Thyroid Cancer Stage IAS-PTCNCT03271892

Deciding on Active Surveillance or Surgery for Primary Management of Low Risk Papillary Thyroid Cancer

An observational study of Thyroid Cancer Stage I, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

This is a prospective observational study. 1. In the first part of the study, consenting eligible adult patients with low risk papillary thyroid cancer that is confined to the thyroid, are provided verbal and written information about their disease and the option of active surveillance (close monitoring with intention… Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Thyroid Cancer Stage I
How many people: 200 participants
Where: 1 siteCanada
Study dates: 11 May 2016to 31 Dec 2031
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Consenting individuals aged 18 years of age or older with papillary thyroid cancer (PTC) who have a primary tumor that is <2cm in maximal diameter, and fine needle aspiration biopsy is positive or suspicious for PTC. The tumor must be confined to the thyroid (no metastatic disease) and not considered in a high risk location (e.g. adjacent to the recurrent laryngeal nerve or trachea). The patient must have no prior surgical treatment for thyroid cancer.

Who may be able to join

Patients 18 years of age or older
Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
No other absolute indications for thyroid or parathyroid surgery
Permission for review of thyroid cancer-related medical records

Who cannot join

Regional or distant metastatic thyroid cancer
History of prior thyroid cancer surgery
High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
Known or suspected poorly differentiated or non-papillary thyroid cancer
Medically unfit for surgery due to co-morbidity

Show all 10Show fewer

Another active malignancy with limited life expectancy of < 1 year.
Pregnancy at the time of study enrollment.
Other absolute indication for thyroid or parathyroid surgery
Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, or other reasons.

Trial locations and contacts

1 site in 1 country.

Canada1 site

University Health Network
Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer

This is a prospective observational study.

In the first part of the study, consenting eligible adult patients with low risk papillary thyroid cancer that is confined to the thyroid, are provided verbal and written information about their disease and the option of active surveillance (close monitoring with intention to treat if disease progresses or if the patient changes her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional standard of care). Patients are free to make their own disease management choice (ie. active surveillance or thyroidectomy) and the investigators are examining how often patients choose each of these options. The investigators are also examining the reasons for their choice.
In the second part of the study, consenting, eligible patients who completed the preceding part of the study and chose either a) active surveillance, or b) thyroid surgery, are tracked with respect to clinical and psychosocial outcomes as well as quality of life. Patients who chose active surveillance are free to change their mind and have surgery at any point, even if the disease does not progress. The primary study outcome is decision regret at one year, in the respective groups of patients who chose active surveillance or thyroidectomy.

Read the detailed description

This is a prospective observational study, consisting of multiple parts.

In the first part of the study, eligible, consenting adult patients with low risk papillary thyroid cancer who have not had thyroid surgery, are provided with verbal and written information about the disease prognosis, surgical treatment outcomes, and the option of active surveillance (close monitoring with the intention of treatment if there is disease progression or if the patient changes her/his mind), as an alternative to immediately proceeding with thyroidectomy. The primary outcome of this part of the study is the final disease management decision of the patient (ie. active surveillance or thyroid surgery) and we are also examining patients' reasons for their choice.
In the second part of this study, eligible consenting patients who completed the preceding part of the study and chose either: a) active surveillance, or b) thyroid surgery, are tracked with respect to disease, treatment, psychosocial outcomes, and quality of life. For patients under active surveillance, clinical follow-up is conducted at a participating study institution. For patients who choose surgery, surgery and related clinical follow-up may be performed at any institution (of the patient's choice), however, the thyroid cancer-related medical records are regularly reviewed. Questionnaires are mailed to patients at one year. The primary outcome for this study is decision regret (on the decision for active surveillance or surgery) at one year after initiating the disease management decision (ie. active surveillance or surgery). As the decision for surgery or active surveillance is up to the patient and the proportion of patients in each group is unknown, the results in respective groups will be reported separately for the primary analysis (and only compared if sufficient numbers are available in each group).

Conditions: Thyroid Cancer Stage I
Keywords: papillary thyroid cancer, thyroidectomy, active surveillance
Medical subject headings: Thyroid Neoplasms, Thyroid Cancer, Papillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03271892
Study group	Role	What they receive
Active surveillance		Patients under active surveillance choose to not have immediate thyroidectomy. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if needed). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.
Immediate Surgery		Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.

What is being measured

The primary outcome is the main question the study is designed to answer.

Disease management decision (first part of the study, focused on treatment management choice)
In the first part of the study, at any time point after study enrollment and receiving written and verbal information about disease prognosis and the option of active surveillance, patients will be asked to provide a final disease management decision (active surveillance or surgery). This decision should be generally finalized within 3 months of enrollment in the study.
Measured: 0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)
Decision regret (second part of the study - follow-up of respective active surveillance and surgical patient groups)
Decision regret (total score, self-administered written questionnaire)
Measured: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)

Secondary outcomes (17)

Disease management decision rationale/explanation
Patients will be asked the reason for choosing active surveillance or surgery once final decision is complete for the disease management plan (i.e. active surveillance or surgery). Each patient will be asked, in a semi-structured interview question, to explain the reason why the disease management strategy that was chosen. The results will be coded and analyzed using a mixed methods approach.
Measured: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Disease management decision-maker identification
Patients will be asked about the extent of their involvement in disease management decision-making
Measured: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Disease management decision satisfaction
Satisfaction with decision scale (overall score)
Measured: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Baseline coping mechanisms in all patients and respective study groups
Brief Cope Questionnaire (description of all respective subscales per the questionnaire developer)
Measured: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Baseline evaluation of fear of disease progression in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Short form of the Fear of Progression Questionnaire (overall score)
Measured: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Fear of disease progression at 1 year follow-up - in respective study groups (active surveillance or surgery)
Short form of the Fear of Progression Questionnaire (overall score)
Measured: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Baseline evaluation of surgical fear in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Surgical Fear Questionnaire (total score)
Measured: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Baseline evaluation of decision self-efficacy in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Decision Self-Efficacy Scale (total score)
Measured: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Psychological distress at 1 year in respective study groups
Hospital Anxiety and Depression Scale (respective total scores for anxiety and depression, respectively)
Measured: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Disease-specific quality of life at 1 year
M.D. Anderson Symptom Inventory (respective Symptom Severity and Symptom Interference with life - respective total scores for these subscales)
Measured: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Body image perception at 1 year
Body Image Scale (overall score)
Measured: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Thyroid cancer surgery in patients who initially choose active surveillance
The number and percent of patients who initially choose active surveillance, but go on to have surgery (with surgical indication) will be evaluated yearly
Measured: From date of enrollment in the active surveillance arm of the study until the date of first documented thyroid cancer surgery or date of death from any cause, whichever comes first, assessed up to 10 years from active surveillance arm study enrollment
Disease progression
Structural disease progression (Defined as follows: primary tumor growth >3 mm in largest diameter in the active surveillance group, or new metastatic disease in either the active surveillance or surgical group, or newly diagnosed thyroid cancer in the thyroid bed/remaining thyroid lobe in the surgical group)
Measured: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented thyroid cancer structural disease progression or death from any cause, whichever comes first, assessed up to 10 years from enrollment
Thyroid surgical complications
Any thyroid surgical complications (defined as hypoparathyroidism, recurrent laryngeal nerve injury, or other surgical complications documented in the medical record) will be ascertained in all patients from either group, who undergo thyroid surgery
Measured: From date of enrollment in the active surveillance or surgical arms of the study until the date of any documented thyroid cancer surgical complication or death from any cause, whichever comes first, assessed up to 10 years from enrollment
New chronic prescription thyroid hormone use
New chronic prescription thyroid hormone use will be ascertained in both study arms. Individuals who are taking chronic prescription thyroid hormone prior to enrollment in the study will be excluded from this analysis.
Measured: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented prescription thyroid hormone use or death from any cause, whichever comes first, assessed up to 10 years from enrollment
Healthcare resource utilization
Thyroid cancer or thyroid cancer care-related expenses/procedures will be ascertained in both study arms including thyroid cancer surgery, thyroid hormone use, thyroid cancer-related diagnostic testing [bloodwork, imaging], thyroid biopsies, other thyroid cancer-related procedures, thyroid cancer-related specialist healthcare provider visits, radioactive iodine treatment or scans, use of recombinant human thyrotropin, or healthcare expenditures for treatments of complications of thyroid surgery [e.g. prescription treatments for hypoparathyroidism]).
Measured: From the date of enrollment until death from any cause or up to 10 years from enrollment
Serum thyroglobulin measurement in the active surveillance group
Serum thyroglobulin (with thyroglobulin antibody) measurement
Measured: Upon enrollment in the active surveillance arm of the study and thereafter every 6 months for 2 years, and thereafter yearly, for up to 10 years, for patients in the active surveillance arm of the study (who do not have surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 201631 Dec 2031

First posted5 Sep 2017
Study start11 May 2016
Primary completion31 Dec 2031 (estimated)
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Thyroid Cancer Stage IStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03271892
Sponsor's protocol ID: 15-8942
Acronym: AS-PTC
Status last verified: Nov 2025
First submitted: 28 Aug 2017
Last updated: 26 Nov 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: We are in discussions with other groups doing active surveillance research, and in future, may share data with such groups. Final plan not yet established.

Publications

Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Su J, Xu W, Esemezie AO, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Long-Term Durability of Active Surveillance of Small, Low-Risk Papillary Thyroid Cancer. JAMA Surg. 2025 Oct 1;160(10):1117-1124. doi: 10.1001/jamasurg.2025.2957.
PubMed 40833769
Sawka AM, Ghai S, Tomlinson G, Rotstein L, Gilbert R, Gullane P, Pasternak J, Brown D, de Almeida J, Irish J, Chepeha D, Higgins K, Monteiro E, Jones JM, Gafni A, Goldstein DP. A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer. BMJ Open. 2018 Apr 12;8(4):e020298. doi: 10.1136/bmjopen-2017-020298.
PubMed 29654030
Sawka AM, Ghai S, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP, On Behalf Of The Canadian Thyroid Cancer Active Surveillance Study Group. Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic. Cancers (Basel). 2021 Jan 20;13(3):371. doi: 10.3390/cancers13030371.
PubMed 33498497
Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Gooden E, Brown DH, Eskander A, Zahedi A, Chung J, Su J, Xu W, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Active Surveillance Study Group (Greater Toronto Area). A Quantitative Analysis Examining Patients' Choice of Active Surveillance or Surgery for Managing Low-Risk Papillary Thyroid Cancer. Thyroid. 2022 Mar;32(3):255-262. doi: 10.1089/thy.2021.0485. Epub 2022 Feb 17.
PubMed 35019770
Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Zahedi A, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP. Decision Regret Following the Choice of Surgery or Active Surveillance for Small, Low-Risk Papillary Thyroid Cancer: A Prospective Cohort Study. Thyroid. 2024 May;34(5):626-634. doi: 10.1089/thy.2023.0634. Epub 2024 Apr 8.
PubMed 38481111
Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Zahedi A, Gooden E, Eskander A, Chung J, Devon K, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Gender Differences in Fears Related to Low-Risk Papillary Thyroid Cancer and Its Treatment. JAMA Otolaryngol Head Neck Surg. 2023 Sep 1;149(9):803-810. doi: 10.1001/jamaoto.2023.1642.
PubMed 37410454
Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.
PubMed 32126932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Deciding on Active Surveillance as an Alternative Option to Surgery in the Primary Management of Low Risk Papillary Thyroid Cancer
ClinicalTrials.gov ID: NCT03271892
Acronym / sponsor ID: AS-PTC / 15-8942
Conditions: Thyroid Cancer Stage I
Keywords: papillary thyroid cancer, thyroidectomy, active surveillance
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: Canadian Cancer Society (CCS), Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
Study start: 11 May 2016 (actual)
Primary completion: 31 Dec 2031 (estimated)
Study completion: 31 Dec 2031 (estimated)
First posted: 5 Sep 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective observational study.

In the first part of the study, consenting eligible adult patients with low risk papillary thyroid cancer that is confined to the thyroid, are provided verbal and written information about their disease and the option of active surveillance (close monitoring with intention to treat if disease progresses or if the patient changes her/his mind), as an alternative to thyroid surgery (thyroidectomy - traditional standard of care). Patients are free to make their own disease management choice (ie. active surveillance or thyroidectomy) and the investigators are examining how often patients choose each of these options. The investigators are also examining the reasons for their choice.
In the second part of the study, consenting, eligible patients who completed the preceding part of the study and chose either a) active surveillance, or b) thyroid surgery, are tracked with respect to clinical and psychosocial outcomes as well as quality of life. Patients who chose active surveillance are free to change their mind and have surgery at any point, even if the disease does not progress. The primary study outcome is decision regret at one year, in the respective groups of patients who chose active surveillance or thyroidectomy.

Detailed description

This is a prospective observational study, consisting of multiple parts.

In the first part of the study, eligible, consenting adult patients with low risk papillary thyroid cancer who have not had thyroid surgery, are provided with verbal and written information about the disease prognosis, surgical treatment outcomes, and the option of active surveillance (close monitoring with the intention of treatment if there is disease progression or if the patient changes her/his mind), as an alternative to immediately proceeding with thyroidectomy. The primary outcome of this part of the study is the final disease management decision of the patient (ie. active surveillance or thyroid surgery) and we are also examining patients' reasons for their choice.
In the second part of this study, eligible consenting patients who completed the preceding part of the study and chose either: a) active surveillance, or b) thyroid surgery, are tracked with respect to disease, treatment, psychosocial outcomes, and quality of life. For patients under active surveillance, clinical follow-up is conducted at a participating study institution. For patients who choose surgery, surgery and related clinical follow-up may be performed at any institution (of the patient's choice), however, the thyroid cancer-related medical records are regularly reviewed. Questionnaires are mailed to patients at one year. The primary outcome for this study is decision regret (on the decision for active surveillance or surgery) at one year after initiating the disease management decision (ie. active surveillance or surgery). As the decision for surgery or active surveillance is up to the patient and the proportion of patients in each group is unknown, the results in respective groups will be reported separately for the primary analysis (and only compared if sufficient numbers are available in each group).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Active surveillance	–	–Patients under active surveillance choose to not have immediate thyroidectomy. Patients are closely monitored with respect to clinical status, ultrasound imaging, biochemical indices (thyroid function, thyroglobulin, and thyroglobulin antibodies) and any thyroid cancer-related treatments (if needed). Active surveillance is conducted at a participating study site. Criteria defining disease progression are established, and if such criteria are met, thyroid surgery is recommended to the patient. However, patients are free to choose to have thyroid surgery at any time, in the absence of disease progression. Thyroid cancer clinical and treatment outcomes are tracked by the study team.
Immediate Surgery	–	–Patients who choose surgery, undergo thyroidectomy, as per current standards of care, by a surgeon of their choice in an institution of their choice. The treating surgeon, in discussion with the patient, will choose the extent of thyroid surgery that may be appropriate for the individual case. Post-surgical follow-up is per the discretion of the treating surgeon, endocrinologist, or other healthcare providers involved in the patient's thyroid cancer care. Thyroid cancer clinical and treatment outcomes are tracked by the study team.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Consenting individuals aged 18 years of age or older with papillary thyroid cancer (PTC) who have a primary tumor that is <2cm in maximal diameter, and fine needle aspiration biopsy is positive or suspicious for PTC. The tumor must be confined to the thyroid (no metastatic disease) and not considered in a high risk location (e.g. adjacent to the recurrent laryngeal nerve or trachea). The patient must have no prior surgical treatment for thyroid cancer.

Key inclusion criteria (6 listed)

Patients 18 years of age or older
Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC).
PTC must be less than 2 cm in maximal diameter on thyroid ultrasound
No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer.
No other absolute indications for thyroid or parathyroid surgery

Key exclusion criteria (10 listed)

Regional or distant metastatic thyroid cancer
History of prior thyroid cancer surgery
High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea)
The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus)
Known or suspected poorly differentiated or non-papillary thyroid cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Disease management decision (first part of the study, focused on treatment management choice)
Time frame: 0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)
In the first part of the study, at any time point after study enrollment and receiving written and verbal information about disease prognosis and the option of active surveillance, patients will be asked to provide a final disease management decision (active surveillance or surgery). This decision should be generally finalized within 3 months of enrollment in the study.
Decision regret (second part of the study - follow-up of respective active surveillance and surgical patient groups)
Time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Decision regret (total score, self-administered written questionnaire)

17 secondary outcomes

Disease management decision rationale/explanation
Time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Disease management decision-maker identification
Time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Disease management decision satisfaction
Time frame: 0 to 3 months after enrollment in the study, once the decision on disease management is finalized (it is expected that the disease management decision should be completed within the time frame of 0 to 3 months)
Baseline coping mechanisms in all patients and respective study groups
Time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Baseline evaluation of fear of disease progression in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Fear of disease progression at 1 year follow-up - in respective study groups (active surveillance or surgery)
Time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Baseline evaluation of surgical fear in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Baseline evaluation of decision self-efficacy in all patients and respective study groups (i.e. those who ultimately choose active surveillance or surgery)
Time frame: Within 1 month of study enrollment (baseline interview after enrollment in the study, prior to being provided detailed information about active surveillance)
Psychological distress at 1 year in respective study groups
Time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Disease-specific quality of life at 1 year
Time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Body image perception at 1 year
Time frame: 1 year after enrolling in the second phase of the study (i.e. one year after enrolling in the active surveillance arm or 1 year after the first thyroid cancer surgery)
Thyroid cancer surgery in patients who initially choose active surveillance
Time frame: From date of enrollment in the active surveillance arm of the study until the date of first documented thyroid cancer surgery or date of death from any cause, whichever comes first, assessed up to 10 years from active surveillance arm study enrollment
Disease progression
Time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented thyroid cancer structural disease progression or death from any cause, whichever comes first, assessed up to 10 years from enrollment
Thyroid surgical complications
Time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of any documented thyroid cancer surgical complication or death from any cause, whichever comes first, assessed up to 10 years from enrollment
New chronic prescription thyroid hormone use
Time frame: From date of enrollment in the active surveillance or surgical arms of the study until the date of first documented prescription thyroid hormone use or death from any cause, whichever comes first, assessed up to 10 years from enrollment
Healthcare resource utilization
Time frame: From the date of enrollment until death from any cause or up to 10 years from enrollment
Serum thyroglobulin measurement in the active surveillance group
Time frame: Upon enrollment in the active surveillance arm of the study and thereafter every 6 months for 2 years, and thereafter yearly, for up to 10 years, for patients in the active surveillance arm of the study (who do not have surgery)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
Background: PubMed 40833769Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Su J, Xu W, Esemezie AO, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Long-Term Durability of Active Surveillance of Small, Low-Risk Papillary Thyroid Cancer. JAMA Surg. 2025 Oct 1;160(10):1117-1124. doi: 10.1001/jamasurg.2025.2957.
Background: PubMed 29654030Sawka AM, Ghai S, Tomlinson G, Rotstein L, Gilbert R, Gullane P, Pasternak J, Brown D, de Almeida J, Irish J, Chepeha D, Higgins K, Monteiro E, Jones JM, Gafni A, Goldstein DP. A protocol for a Canadian prospective observational study of decision-making on active surveillance or surgery for low-risk papillary thyroid cancer. BMJ Open. 2018 Apr 12;8(4):e020298. doi: 10.1136/bmjopen-2017-020298.
Background: PubMed 33498497Sawka AM, Ghai S, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP, On Behalf Of The Canadian Thyroid Cancer Active Surveillance Study Group. Decision-making in Surgery or Active Surveillance for Low Risk Papillary Thyroid Cancer During the COVID-19 Pandemic. Cancers (Basel). 2021 Jan 20;13(3):371. doi: 10.3390/cancers13030371.
Background: PubMed 35019770Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Gooden E, Brown DH, Eskander A, Zahedi A, Chung J, Su J, Xu W, Ihekire O, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Active Surveillance Study Group (Greater Toronto Area). A Quantitative Analysis Examining Patients' Choice of Active Surveillance or Surgery for Managing Low-Risk Papillary Thyroid Cancer. Thyroid. 2022 Mar;32(3):255-262. doi: 10.1089/thy.2021.0485. Epub 2022 Feb 17.
Background: PubMed 38481111Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Monteiro E, Chung J, Zahedi A, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP. Decision Regret Following the Choice of Surgery or Active Surveillance for Small, Low-Risk Papillary Thyroid Cancer: A Prospective Cohort Study. Thyroid. 2024 May;34(5):626-634. doi: 10.1089/thy.2023.0634. Epub 2024 Apr 8.
Background: PubMed 37410454Sawka AM, Ghai S, Rotstein L, Irish JC, Pasternak JD, Gullane PJ, Monteiro E, Zahedi A, Gooden E, Eskander A, Chung J, Devon K, Su J, Xu W, Jones JM, Gafni A, Baxter NN, Goldstein DP; Canadian Thyroid Cancer Active Surveillance Study Group (Greater Toronto Area). Gender Differences in Fears Related to Low-Risk Papillary Thyroid Cancer and Its Treatment. JAMA Otolaryngol Head Neck Surg. 2023 Sep 1;149(9):803-810. doi: 10.1001/jamaoto.2023.1642.
Background: PubMed 32126932Sawka AM, Ghai S, Yoannidis T, Rotstein L, Gullane PJ, Gilbert RW, Pasternak JD, Brown DH, Eskander A, Almeida JR, Irish JC, Higgins K, Enepekides DJ, Monteiro E, Banerjee A, Shah M, Gooden E, Zahedi A, Korman M, Ezzat S, Jones JM, Rac VE, Tomlinson G, Stanimirovic A, Gafni A, Baxter NN, Goldstein DP. A Prospective Mixed-Methods Study of Decision-Making on Surgery or Active Surveillance for Low-Risk Papillary Thyroid Cancer. Thyroid. 2020 Jul;30(7):999-1007. doi: 10.1089/thy.2019.0592. Epub 2020 Apr 8.
Protocol manuscript - PMID: 29654030Link provided by the sponsor.
Study websiteLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. We are in discussions with other groups doing active surveillance research, and in future, may share data with such groups. Final plan not yet established.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna M Sawka, MD,PhD principal investigator

University Health Network, Toronto

David P Goldstein, MD, PhD principal investigator

University Health Network, Toronto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Cancer Stage I, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease management decision (first part of the study, focused on treatment management choice) (time frame: 0 to 3 months after enrollment in the study (as it is expected that the disease management decision should be completed within that time frame)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03271892, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.