Papillary Thyroid CancerNCT01974284
Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
A study testing percutaneous ethanol ablation in people with Papillary Thyroid Cancer, run by Yale University at 1 site in United States.
Trial summary
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer
- What is being tested?
- percutaneous ethanol ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 29 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and older
- Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound
Who cannot join
- Patient refusal to participate
- History of prior thyroid or parathyroid surgery
- Previous recurrent laryngeal nerve injury
- Inability to make decisions or comply with follow up
- Co-existing indication for thyroidectomy
- Aggressive cytological or molecular features
Show all 12Show fewer
- Multifocal papillary thyroid carcinoma
- Pregnant or breast-feeding
- Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea)
- Documented or suspected distant metastasis
- History of radiation to neck or face
- Family history of thyroid cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Endocrine Surgery Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06520
About this study
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.
Read the detailed description
We hypothesize that percutaneous ethanol ablation (PEA) for primary papillary thyroid microcarcinoma (PTMC) has equivalent oncologic outcomes to current treatment options including observation, thyroid lobectomy and total thyroidectomy. In addition, we hypothesize that it will yield superior long-term quality of life, including measures of pain, voice, and cosmesis than standard surgical therapy (total thyroidectomy). If our hypotheses are correct, the findings of this study have the potential to fundamentally change clinical management of this group of patients.
This study was changed from its initial design: a 2 arm study comparing PEA to surgery (Amended April 30, 2015). The change in design was made based on several discussions within Yale Endocrine Surgery, with patients diagnosed with PTMC, and knowledge of other institutions performing PEA for PTMC as standard of care.
The study team had been contacted by numerous potential subjects interested in PEA who were unwilling to be randomized to surgery. Because patients interested in PEA appeared to be firmly against the idea of thyroidectomy, we believed that we would be unable to enroll sufficient patients to this study as the protocol originally stood.
- Conditions
- Papillary Thyroid Cancer
- Being tested
- percutaneous ethanol ablation
- Medical subject headings
- Thyroid Cancer, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous ethanol ablationDrug
Also called percutaneous, ethanol, ablation, papillary
The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous ethanol ablation | Experimental | The experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma. Receives: Drug: percutaneous ethanol ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Measured: 5 years
Overall Survival
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
Measured: 5 years
Secondary outcomes (2)
Quality of Life
The Short-Form-36 (SF-36) health survey is a patient-reported survery that evaluates the patient's health status. It consists of 8 scaled scores which are the weighted sums of the questions in each section. The 8 sections that are tested are vitality, physical functioning, bodily pain, general role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale; the higher the score, the less disability (i.e. the score of 0 is equivalent to maximal disability, and the score of 100 is equivalent of no disability). The SF-36 is a set of easily-administered quality-of-life measures and is a validated tool to evaluate patient quality of life.
Measured: 5 years
Patient Satisfaction
Patient satisfaction will be assessed by evaluating the following: pain with the "Brief Pain Inventory" (BPI), voice with the "Voice Handicap Index" (VHI) and cosmesis with the "Patient and Observer Scar Assessment Scale" (POSAS). The BPI is a simple, well-accepted instrument for the objective assessment of pain. The VHI is an established tool used to assess voice after an intervention. POSAS is a validated tool for the evaluation of surgical scars.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMar 2014
- Primary completion2 Mar 2017
- Study completion29 Jun 2017
Why it stopped: Lack of patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Papillary Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenda Callender, MD, Principal investigator, Yale University- Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974284
- Sponsor's protocol ID
- HIC1312013168
- Status last verified
- Nov 2019
- First submitted
- 25 Oct 2013
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Ethanol Injection for Primary Papillary Thyroid Microcarcinoma
- ClinicalTrials.gov ID
- NCT01974284
- Acronym / sponsor ID
- HIC1312013168
- Conditions
- Papillary Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We assess the effectiveness of percutaneous ethanol ablation for the treatment of thyroid cancer.
Detailed description
We hypothesize that percutaneous ethanol ablation (PEA) for primary papillary thyroid microcarcinoma (PTMC) has equivalent oncologic outcomes to current treatment options including observation, thyroid lobectomy and total thyroidectomy. In addition, we hypothesize that it will yield superior long-term quality of life, including measures of pain, voice, and cosmesis than standard surgical therapy (total thyroidectomy). If our hypotheses are correct, the findings of this study have the potential to fundamentally change clinical management of this group of patients.
This study was changed from its initial design: a 2 arm study comparing PEA to surgery (Amended April 30, 2015). The change in design was made based on several discussions within Yale Endocrine Surgery, with patients diagnosed with PTMC, and knowledge of other institutions performing PEA for PTMC as standard of care.
The study team had been contacted by numerous potential subjects interested in PEA who were unwilling to be randomized to surgery. Because patients interested in PEA appeared to be firmly against the idea of thyroidectomy, we believed that we would be unable to enroll sufficient patients to this study as the protocol originally stood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| percutaneous ethanol ablation | Experimental | Drug: percutaneous ethanol ablationThe experimental group of the study is comprised of patients that will undergo percutaneous ethanol ablation for the management of papillary thyroid microcarcinoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years and older
- Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound
Key exclusion criteria (12 listed)
- Patient refusal to participate
- History of prior thyroid or parathyroid surgery
- Previous recurrent laryngeal nerve injury
- Inability to make decisions or comply with follow up
- Co-existing indication for thyroidectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous ethanol ablationAlso: percutaneous, ethanol, ablation, papillaryThe volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia. | Drug | percutaneous ethanol ablation |
Primary outcome
Disease-free
Time frame: 5 years
Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.
Overall Survival
Time frame: 5 years
Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.
2 secondary outcomes
Quality of Life
Time frame: 5 years
Patient Satisfaction
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Glenda Callender, MD principal investigator
Yale University- Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous ethanol ablation in people with Papillary Thyroid Cancer, run by Yale University at 1 site in United States.
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 2 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 Nov 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-free (time frame: 5 years). 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?
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 25 Nov 2019.