Stage I Papillary Thyroid CancerPhase 2NCT02138214
Central Neck Dissection in Patients With Clinical Node Negative Thyroid Cancer
A Phase 2 study testing Thyroidectomy, entral lymph node dissection (CLND) and Quality-of-life assessment in people with Stage I Papillary Thyroid Cancer and Stage II Papillary Thyroid Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Read more about this study
- Who is it for?
- Ages 21 to 73 years
- Conditions the study is for
- Stage I Papillary Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage III Papillary Thyroid Cancer
- What is being tested?
- Thyroidectomy, entral lymph node dissection (CLND) and Quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2014to 26 Oct 2020
- Phase
- Phase 2
- 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 21 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
- No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
- No evidence of distant metastases
- Ability to read and write in English
Who cannot join
- Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
- Previous thyroid surgery
- Concurrent active malignancy of another type
- Inability to give informed consent or lacks decision making capacity
- T4 tumor
- Pre-existing vocal cord paralysis
Show all 12Show fewer
- Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
- Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function
- Becomes pregnant before surgery or at any time while on study
- INTRA-OPERATION EXCLUSION CRITERIA (randomization arms only)
- Evidence of nodal involvement identified in the operating room (OR)
- Failure to confirm diagnosis of cancer in participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the rate of transient and permanent hypocalcemia
SECONDARY OBJECTIVES:
- To determine the rate of voice and swallowing problems.
II. To determine the degree to which quality of life (QOL) is compromised.
III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques.
IV. To determine clinical recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.
Arm I: Patients undergo total thyroidectomy alone.
Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).
Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up.
After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.
- Conditions
- Stage I Papillary Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage III Papillary Thyroid Cancer
- Being tested
- Thyroidectomy, entral lymph node dissection (CLND), Quality-of-life assessment
- 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.
ThyroidectomyProcedure or surgery
Undergo total thyroidectomy
entral lymph node dissection (CLND)Procedure or surgery
Undergo total thyroidectomy with ipsilateral prophylactic CND
Quality-of-life assessmentOther
Voice evaluation, interviews, ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (no CND) | Experimental | Patients undergo total thyroidectomy alone. Receives: Procedure: Thyroidectomy; Other: Quality-of-life assessment |
| Arm II (CND) | Experimental | Patients undergo total thyroidectomy with ipsilateral prophylactic CND. Receives: Procedure: Thyroidectomy; Procedure: entral lymph node dissection (CLND); Other: Quality-of-life assessment |
| Arm III (SOC) | Active comparator | Patients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference Receives: Other: Quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml
Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.
Measured: Post-operative day 1
Post-operative Serum Calcium (mg/dL) at Day 12
Post-operative serum calcium (mg/dL) at Day 12
Measured: At day 12
Total Calcium Consumption in First 2 Weeks
Total calcium consumption in first 2 weeks (total mg). Participants were given calcium symptom logs in which to record their calcium consumption between surgery and their first preoperative follow up appointment, approximately two week.
Measured: 2 weeks after surgery
Number of Participants With Hypocalcemia Symptoms in First 2 Weeks
Number of participants with hypocalcemia symptoms and symptom severity in first two weeks, as defined by presence of clinically significant symptoms of hypocalcemia.
Clinically significant symptoms defined as 1 or more episodes of symptoms of hypocalcemia per day for multiple days, symptoms leading to calls to provider for assistance with managing and/or symptoms leading to escalation of dosage of prescribed medications to treat symptoms of hypocalcemia
Measured: 2 weeks
Hypocalcemia Symptom Severity Scale (Range of 1-5)
Mean number of occurrences of mild (severity 1 - 2) and severe (severity 3 - 5) hypocalcemia symptoms. Participants were asked to record hypocalcemia symptoms between surgery and first postoperative follow-up at approximately two weeks in their provided calcium symptom logs and rank severity on scale of 1 (mild) to 5 (severe).
Measured: 2 weeks post surgery
Percentage of Participants That Required Calcium and Calcitriol at Month 6
Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH <15 pg/ml)
Measured: At Month 6
Post-operative Serum PTH (pg/ml) at Month 6
Measured: At Month 6
Post-operative Serum Calcium Level at Month 6
Post-operative serum calcium (mg/dL) at Month 6
Measured: At Month 6
Secondary outcomes (5)
Rate of Transient and Permanent Hypocalcemia
The rate of transient and permanent hypocalcemia will be determined by assessing the following:
- Post-operative serum calcium (mg/dl) and PTH (pg/ml) at Day 12 and Month 6 II. Total calcium consumption in first 2 weeks (total gm) III. Hypocalcemia symptoms in first 2 weeks (average episodes/day) IV. Hypocalcemia symptom severity scale (range 1-5) V. Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH < 15 pg/ml
Data will be analyzed using the methods described above.
Measured: Post-operative day 1 - Month 6
Rate of Voice and Swallowing Problems
The rate of voice and swallowing problems will be determined by assessing the following:
- Phonation threshold pressure, in centimeters of water II. Dysphonia severity index (DSI) score (+5 to -5) III. Grade Roughness Breathiness Asthenia Strain (GRBAS) score (0-3) IV. Voice quality parameters as measured by Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) (0-100 on visual analog scale) V. Vocal fold vibratory and movement parameters as measured by stroboscopy assessment (1-4) VI. Glottal function index score VII. Penetration-Aspiration score as measured by videofluoroscopic swallow study (0-8)
Data will be analyzed using the methods described above.
Measured: Post operative day 1 - up to 1 year
Degree to Which Quality of Life (QOL) is Compromised
The degree to which quality (QOL) is compromised will be determined by assessing the following:
- Short Form Health Survey (SF-12) Mental Composite Scale (MCS) score II. Short Form Health Survey (SF-12) Physical Composite Scale (PCS) score III. European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core-30 (C30) score IV. Thyroid Cancer Specific Quality of Life (ThyCA-QOL) score V. 10-item Eating Assessment Tool (EAT-10) dysphagia inventory score VI. Voice Handicap Index (VHI) score VII. Themes and codes from interview transcripts assessed using qualitative research methods
Data will be analyzed using the methods described above.
Measured: Post-operative day 1 - up to 1 year
Clinical Recurrence Rates
Clinical recurrence rates will be determined by assessing the following:
- Percent of patients with a recombinant thyroid-stimulating hormone (rTSH) stimulated thyroglobulin level < 1 ng/ml one year after surgery II. Unstimulated thyroglobulin level prior to beginning week 6 radioactive iodine treatment III. Stimulated thyroglobulin at the time of week 6 radioactive iodine treatment IV. Incidence of unstimulated thyroglobulin > 1 ng/mL at 6 months V. Incidence of stimulated thyroglobulin > 2 ng/mL at 1 year VI. Incidence of biopsy-proven disease identification on neck ultrasound or iodine-131 (I-131) uptake up to 5 years post-surgery
Data will be analyzed using the methods described above.
Measured: Week 6 - up to 5 years
Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques
The degree to which accurate quality of life (QOL) measures can be extracted from patient interview narratives using natural language process techniques will allow for the development of computer algorithms that convert patient narrative text into simple quality of life measures. Data will be analyzed using the methods described above.
Measured: Post-operative day 1 - up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start6 Jun 2014
- Primary completion30 Oct 2019
- Study completion26 Oct 2020
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stage I Papillary Thyroid CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Sippel, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138214
- Sponsor's protocol ID
- UW13115
- Other IDs
- NCI-2014-00833, UW13115, R01CA176911, 2014-0391, A539700, SMPH\SURGERY\SURGERY
- Status last verified
- Feb 2020
- First submitted
- 12 May 2014
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Knigge MA, Robbins D, Thibeault S, Connor N, Sippel R. Secondary analyses of swallowing efficiency and safety outcomes following thyroidectomy versus thyroidectomy plus prophylactic central neck dissection. Thyroid Res. 2025 Sep 16;18(1):45. doi: 10.1186/s13044-025-00264-5.
PubMed 40954474Sippel RS, Robbins SE, Poehls JL, Pitt SC, Chen H, Leverson G, Long KL, Schneider DF, Connor NP. A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer. Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345.
PubMed 33759836Kletzien H, Macdonald CL, Orne J, Francis DO, Leverson G, Wendt E, Sippel RS, Connor NP. Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):995-1003. doi: 10.1001/jamaoto.2018.0309.
PubMed 29710208
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Gland Removal With or Without Central Lymph Node Dissection in Treating Patients With Node Negative Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02138214
- Acronym / sponsor ID
- UW13115
- Conditions
- Stage I Papillary Thyroid Cancer, Stage II Papillary Thyroid Cancer, Stage III Papillary Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well thyroid gland removal with or without central lymph node dissection works in treating patients with thyroid cancer or suspected thyroid cancer that has not spread to the lymph nodes (randomized into Arms I and II). Arms I and II are compared to a standard of care (SOC) Arm III to enable comparison of quality of life among various surgical treatments. Currently, the standard treatment for thyroid cancer is total thyroidectomy, or complete removal of the thyroid. The lymph nodes in the central part of the neck may also be surgically removed, called central lymph node dissection. Prophylactic removal of the lymph nodes may increase the risk of life-threatening complications, and may reduce post-surgery quality of life. It may also prevent the cancer from returning and reduce the need for additional surgery. It is not yet known whether recurrence rates and complication levels are lower after thyroid gland removal alone or with central lymph node dissection.
Detailed description
PRIMARY OBJECTIVES:
- To determine the rate of transient and permanent hypocalcemia
SECONDARY OBJECTIVES:
- To determine the rate of voice and swallowing problems.
II. To determine the degree to which quality of life (QOL) is compromised.
III. To determine the degree to which accurate quality of life measures can be extracted from patient interview narratives using natural language processing techniques.
IV. To determine clinical recurrence rates.
OUTLINE: Patients are randomized to 1 of 2 treatment arms, if ineligible into a SOC arm.
Arm I: Patients undergo total thyroidectomy alone.
Arm II: Patients undergo total thyroidectomy with ipsilateral prophylactic central neck dissection (CND).
Arm III: Patients ineligible to be randomized into Arm I or II, Standard of Care (SOC) comparator receiving same follow up.
After completion of study treatment, patients are followed up at day 1, 2 and 6 weeks, and 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (no CND) | Experimental | Procedure: Thyroidectomy, Other: Quality-of-life assessmentPatients undergo total thyroidectomy alone. |
| Arm II (CND) | Experimental | Procedure: Thyroidectomy, Procedure: entral lymph node dissection (CLND), Other: Quality-of-life assessmentPatients undergo total thyroidectomy with ipsilateral prophylactic CND. |
| Arm III (SOC) | Active comparator | Other: Quality-of-life assessmentPatients who are not eligible for randomization into Arm I or Arm II, Standard of Care (SOC) group. No specific trial intervention, treated as per patient and physician preference |
Who may qualify
- Ages
- 21 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA)
- No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only)
- No evidence of distant metastases
- Ability to read and write in English
Key exclusion criteria (12 listed)
- Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
- Previous thyroid surgery
- Concurrent active malignancy of another type
- Inability to give informed consent or lacks decision making capacity
- T4 tumor
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 |
|---|---|---|
| ThyroidectomyUndergo total thyroidectomy | Procedure or surgery | Arm I (no CND), Arm II (CND) |
| entral lymph node dissection (CLND)Undergo total thyroidectomy with ipsilateral prophylactic CND | Procedure or surgery | Arm II (CND) |
| Quality-of-life assessmentVoice evaluation, interviews, ancillary studies | Other | Arm I (no CND), Arm II (CND), Arm III (SOC) |
Primary outcome
Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml
Time frame: Post-operative day 1
Rate of transient hypoparathyroidism will be assessed in terms of percentage of participants with day 1 serum PTH level of < 10 pg/ml.
Post-operative Serum Calcium (mg/dL) at Day 12
Time frame: At day 12
Post-operative serum calcium (mg/dL) at Day 12
Total Calcium Consumption in First 2 Weeks
Time frame: 2 weeks after surgery
Total calcium consumption in first 2 weeks (total mg). Participants were given calcium symptom logs in which to record their calcium consumption between surgery and their first preoperative follow up appointment, approximately two week.
Number of Participants With Hypocalcemia Symptoms in First 2 Weeks
Time frame: 2 weeks
Number of participants with hypocalcemia symptoms and symptom severity in first two weeks, as defined by presence of clinically significant symptoms of hypocalcemia. Clinically significant symptoms defined as 1 or more episodes of symptoms of hypocalcemia per day for multiple days, symptoms leading to calls to provider for assistance with managing and/or symptoms leading to escalation of dosage of prescribed medications to treat symptoms of hypocalcemia
Hypocalcemia Symptom Severity Scale (Range of 1-5)
Time frame: 2 weeks post surgery
Mean number of occurrences of mild (severity 1 - 2) and severe (severity 3 - 5) hypocalcemia symptoms. Participants were asked to record hypocalcemia symptoms between surgery and first postoperative follow-up at approximately two weeks in their provided calcium symptom logs and rank severity on scale of 1 (mild) to 5 (severe).
Percentage of Participants That Required Calcium and Calcitriol at Month 6
Time frame: At Month 6
Requirement for calcium and calcitriol at Month 6 (or, if laboratory values at visit reveal calcium < 8 mg/dL and PTH <15 pg/ml)
Post-operative Serum PTH (pg/ml) at Month 6
Time frame: At Month 6
Post-operative Serum Calcium Level at Month 6
Time frame: At Month 6
Post-operative serum calcium (mg/dL) at Month 6
5 secondary outcomes
Rate of Transient and Permanent Hypocalcemia
Time frame: Post-operative day 1 - Month 6
Rate of Voice and Swallowing Problems
Time frame: Post operative day 1 - up to 1 year
Degree to Which Quality of Life (QOL) is Compromised
Time frame: Post-operative day 1 - up to 1 year
Clinical Recurrence Rates
Time frame: Week 6 - up to 5 years
Degree to Which Accurate Quality of Life (QOL) Measures Can be Extracted From Patient Interview Narratives Using Natural Language Processing Techniques
Time frame: Post-operative day 1 - up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40954474Knigge MA, Robbins D, Thibeault S, Connor N, Sippel R. Secondary analyses of swallowing efficiency and safety outcomes following thyroidectomy versus thyroidectomy plus prophylactic central neck dissection. Thyroid Res. 2025 Sep 16;18(1):45. doi: 10.1186/s13044-025-00264-5.
- Derived from this study: PubMed 33759836Sippel RS, Robbins SE, Poehls JL, Pitt SC, Chen H, Leverson G, Long KL, Schneider DF, Connor NP. A Randomized Controlled Clinical Trial: No Clear Benefit to Prophylactic Central Neck Dissection in Patients With Clinically Node Negative Papillary Thyroid Cancer. Ann Surg. 2020 Sep 1;272(3):496-503. doi: 10.1097/SLA.0000000000004345.
- Derived from this study: PubMed 29710208Kletzien H, Macdonald CL, Orne J, Francis DO, Leverson G, Wendt E, Sippel RS, Connor NP. Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Nov 1;144(11):995-1003. doi: 10.1001/jamaoto.2018.0309.
- University of Wisconsin Carbone Cancer Center HomepageLink provided by the sponsor.
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Thyroid Cancer Stage I
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.
Rebecca Sippel principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thyroidectomy, entral lymph node dissection (CLND) and Quality-of-life assessment in people with Stage I Papillary Thyroid Cancer and Stage II Papillary Thyroid Cancer, run by University of Wisconsin, Madison 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 4 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: finished, as of the sponsor's last update on 21 Dec 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2020). 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?
Percentage of Participants With Transient Hypoparathyroidism, as Defined by a Day 1 Serum Parathyroid Hormone (PTH) Level of < 10 pg/ml (time frame: Post-operative day 1). The study lists 8 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 NCT02138214, which also lists 3 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 21 Dec 2020.