Well Differentiated Thyroid CarcinomaNCT04500925
The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience
An observational study of Well Differentiated Thyroid Carcinoma and Papillary Thyroid Cancer, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of the risk for disease-specific recurrence is essential for deciding between partial (low risk) and completion (high risk) thyroidectomies. Read more about this study
- Who is it for?
- Ages 38 to 61 years
- Conditions the study is for
- Well Differentiated Thyroid Carcinoma, Papillary Thyroid Cancer
- What is being tested?
- UNILATERAL THYROIDECTOMY
- Type of treatment
- Surgery or procedure
- How many people
- 301 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 38 to 61 years
- All sexes
- Adult
Study population: The medical charts of all patients who underwent thyroid surgery between January 2006 and December 2018 in TASMC were retrieved. Most of them were females. The mean age of the entire cohort was 49.59 ± 15.17 years (median 50 years, interquartile range 38-61].
Who may be able to join
- All patients who underwent thyroid surgery (partial and total) between 2006-2018 at Tel Aviv Sourasky Medical Center (TASMC) were included
Who cannot join
- Patients with evidence of cervical lymph node metastasis, other malignancies, adverse imaging features (i.e., extracapsular spread of thyroid malignancy, vocal cord paralysis or immobility in physical examination) were excluded from the study.
About this study
Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of the risk for disease-specific recurrence is essential for deciding between partial (low risk) and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels are re-stratified according to surgical and final histopathological findings. The American Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size and without suspicious features may be suitable candidates for partial thyroidectomy. The incidence and clinical implications of high-risk features discovered postoperatively in patients with preoperatively determined low-risk WDTC have not been previously reported.
Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical Center were included. Pre- and postoperative risk stratifications were performed, and the rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.
- Being tested
- UNILATERAL THYROIDECTOMY
- Keywords
- Low risk, Risk stratification, Partial thyroidectomy, Hemithyroidectomy, Completion Thyroidectomy
- 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.
UNILATERAL THYROIDECTOMYProcedure or surgery
Also called TOTAL THYROIDECTOMY
| Study group | Role | What they receive |
|---|---|---|
| UPSCALED | Not described Receives: Procedure: UNILATERAL THYROIDECTOMY | |
| NOT UPSCALED | Not described Receives: Procedure: UNILATERAL THYROIDECTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-specific recurrence
WDTC recurrence
Measured: 2006-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jan 2006
- Primary completion1 Jan 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well Differentiated Thyroid CarcinomaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Retrospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500925
- Sponsor's protocol ID
- TASMC-20-NC-TLV-704-16-CTIL
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Postoperative Re-stratification for Recurrence in Well-differentiated Thyroid Cancer - A Single Tertiary Israeli Center Experience
- ClinicalTrials.gov ID
- NCT04500925
- Acronym / sponsor ID
- TASMC-20-NC-TLV-704-16-CTIL
- Keywords
- Low risk, Risk stratification, Partial thyroidectomy, Hemithyroidectomy, Completion Thyroidectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 5 Aug 2020 (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.
Background After diagnosing well-differentiated thyroid cancer (WDTC), careful assessment of the risk for disease-specific recurrence is essential for deciding between partial (low risk) and completion (high risk) thyroidectomies. Patients' preoperatively determined risk levels are re-stratified according to surgical and final histopathological findings. The American Thyroid Association 2015 guidelines suggest that patients with WDTC between 1-4 cm in size and without suspicious features may be suitable candidates for partial thyroidectomy. The incidence and clinical implications of high-risk features discovered postoperatively in patients with preoperatively determined low-risk WDTC have not been previously reported.
Methods All thyroidectomies performed between 2006-2018 in the Tel Aviv Sourasky Medical Center were included. Pre- and postoperative risk stratifications were performed, and the rate of completion thyroidectomy was determined. Patients with 1-4 cm WDTC without evidence of positive cervical lymph nodes, invasion to adjacent structures, or high-risk cytology were considered at low risk for disease-specific recurrence and therefore suitable for lobectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UPSCALED | – | Procedure: UNILATERAL THYROIDECTOMY |
| NOT UPSCALED | – | Procedure: UNILATERAL THYROIDECTOMY |
Who may qualify
- Ages
- 38 to 61 years
- Sex
- All
- Age groups
- Adult
- Study population
- The medical charts of all patients who underwent thyroid surgery between January 2006 and December 2018 in TASMC were retrieved. Most of them were females. The mean age of the entire cohort was 49.59 ± 15.17 years (median 50 years, interquartile range 38-61].
Key inclusion criteria (1 listed)
- All patients who underwent thyroid surgery (partial and total) between 2006-2018 at Tel Aviv Sourasky Medical Center (TASMC) were included
Key exclusion criteria (1 listed)
- Patients with evidence of cervical lymph node metastasis, other malignancies, adverse imaging features (i.e., extracapsular spread of thyroid malignancy, vocal cord paralysis or immobility in physical examination) were excluded from the study.
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 |
|---|---|---|
| UNILATERAL THYROIDECTOMYAlso: TOTAL THYROIDECTOMY | Procedure or surgery | NOT UPSCALED, UPSCALED |
Primary outcome
disease-specific recurrence
Time frame: 2006-2018
WDTC recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Well Differentiated Thyroid Carcinoma and Papillary Thyroid Cancer, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 1 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 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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-specific recurrence (time frame: 2006-2018). 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 5 Aug 2020.