Papillary Thyroid MicrocarcinomaNCT01648569
Long-term Outcomes of Total Thyroidectomy Versus Less Than Total Thyroidectomy for Papillary Thyroid Microcarcinoma
An observational study of Papillary Thyroid Microcarcinoma, run by Korean Association of Endocrine Surgeons at 1 site in South Korea.
Trial summary
Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have excellent long-term outcomes, some patients experience tumor recurrence, either locally or, less frequently, as distant metastases, with some patients dying due to this disease. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- Papillary Thyroid Microcarcinoma
- How many people
- 2,014 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Jul 2012
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We evaluated 2014 patients with PTMC who underwent TT (n=1015) or LT (n=999) between March 1986 and December 2006 and for whom complete follow-up data were available for at least 5 years (median 11.8 years; range 5-26 years).
Who may be able to join
- From March 1986 to December 2006, a total of 5042 patients with PTC (of all tumor sizes) underwent initial surgical therapy at our institution. Of these, 2441 patients (48.4%) had PTMCs ≤1 cm in diameter, with 1270 undergoing TT and 1171 undergoing LT. Complete follow-up data for major clinical events were available for 2014 patients (82.5%), including 1015 (79.9%) of the TT group and 999 (85.3%) of the LT group (p=0.083). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria.
Who cannot join
- Patients with follow-up loss
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proper Extent of Surgery for Papillary Microcarcinoma
Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have excellent long-term outcomes, some patients experience tumor recurrence, either locally or, less frequently, as distant metastases, with some patients dying due to this disease. The natural course of PTMC has not always been universally accepted, thus creating controversy concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to confidently identify PTMCs that would take aggressive courses if left untreated. Treatment recommendations range from observation alone to vigorous intervention featuring total thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation. Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on which therapy is the most appropriate. Moreover, the impact of several clinicopathologic risk factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in diameter may have a better prognosis than patients with tumors 0.5-1 cm in size.
Most studies evaluating the proper extent of surgery for PTMC have been retrospective in design. A prospective, long-term, randomized study in a large number of patients, however, may not be feasible owing to the need for an extensive follow-up duration, the costs associated with such a study, and, particularly, its ethical constraints. Consequently, it is not currently possible to determine the prognosis of patients with PTMC or the proper therapeutic approach in these patients. The investigators therefore compared long-term outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than total thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients with PTMC, using propensity-score matching to adjust for the uncontrolled assignment of surgical extent in these patients. In addition, the investigators evaluated whether tumor size, ≤ 0.5 cm or > 0.5 cm, had a significant impact in determining the extent of surgery in patients with PTMC.
Read the detailed description
Study population From March 1986 to December 2006, a total of 5042 patients with PTC (of all tumor sizes) underwent initial surgical therapy at our institution. Of these, 2441 patients (48.4%) had PTMCs ≤ 1 cm in diameter, with 1270 undergoing TT and 1171 undergoing LT. Complete follow-up data for major clinical events were available for 2014 patients (82.5%), including 1015 (79.9%) of the TT group and 999 (85.3%) of the LT group (p=0.083). Patients were followed-up for a median 11.8 years (range, 5 to 26 years). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria. The study protocol was approved by our Institutional Review Board. Details of patients' presentations, surgical and pathologic findings, and adjunctive treatments were obtained from the Yonsei University Thyroid Cancer Database.
Management strategy In patients diagnosed with PTMC after a complete radiologic and histologic examination, the extent of thyroidectomy and radioactive iodine (RI) therapy were based on prognostic factors. However, the protocol of our institution as to how PTMC should be appropriately managed has been changed according to update of clinical reports and validated treatment guidelines. Therefore, the lack of a standardized approach during the study period allowed us to assess the impact of various therapeutic modalities, especially extent of thyroidectomy, in patients with PTMC.
- Conditions
- Papillary Thyroid Microcarcinoma
- Medical subject headings
- Papillary Thyroid Microcarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival in patients with papillary thyroid microcarcinoma
We analyzed overall survival in patients with PTMC. We also compared the overall survival between total thyroidectomy group versus less than total thyroidectomy group. Survival curves were constructed using the Kaplan-Meier method and compared using the log-rank test.
Measured: Overall survival (10-year)
Secondary outcomes (1)
Disease-free survival in patients with papillary thyroid microcarcinoma
We analyzed disease-free survival in patients with PTMC. We also compared the disease-free survival between total thyroidectomy group versus less than total thyroidectomy group. Survival curves were constructed using the Kaplan-Meier method and compared using the log-rank test.
Measured: Disease-free survival (10-year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary Thyroid MicrocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Association of Endocrine Surgeons
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jandee Lee, Korean Association of Endocrine Surgeons
- Investigators
- Woong Youn Chung, Study chair, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648569
- Sponsor's protocol ID
- KoreanAES003
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proper Extent of Surgery for Papillary Microcarcinoma
- ClinicalTrials.gov ID
- NCT01648569
- Acronym / sponsor ID
- KoreanAES003
- Conditions
- Papillary Thyroid Microcarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,014 participants (actual)
- Lead sponsor
- Korean Association of Endocrine SurgeonsResearch network
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Jul 2012 (estimated)
- 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.
Although the vast majority of patients with Papillary Thyroid Microcarcinoma (PTMC) have excellent long-term outcomes, some patients experience tumor recurrence, either locally or, less frequently, as distant metastases, with some patients dying due to this disease. The natural course of PTMC has not always been universally accepted, thus creating controversy concerning the diagnosis and treatment of PTMC. Further, it is not yet possible to confidently identify PTMCs that would take aggressive courses if left untreated. Treatment recommendations range from observation alone to vigorous intervention featuring total thyroidectomy, prophylactic cervical lymph node dissection, and adjuvant RI ablation. Therefore, no consensus has yet been reached on the biological aggressiveness of PTMC or on which therapy is the most appropriate. Moreover, the impact of several clinicopathologic risk factors, including tumor size, is unclear, although patients with tumors ≤ 0.5cm in diameter may have a better prognosis than patients with tumors 0.5-1 cm in size.
Most studies evaluating the proper extent of surgery for PTMC have been retrospective in design. A prospective, long-term, randomized study in a large number of patients, however, may not be feasible owing to the need for an extensive follow-up duration, the costs associated with such a study, and, particularly, its ethical constraints. Consequently, it is not currently possible to determine the prognosis of patients with PTMC or the proper therapeutic approach in these patients. The investigators therefore compared long-term outcomes after total thyroidectomy (TT: total or near-total thyroidectomy) or less than total thyroidectomy (LT: lobectomy or subtotal thyroidectomy) in a large cohort of patients with PTMC, using propensity-score matching to adjust for the uncontrolled assignment of surgical extent in these patients. In addition, the investigators evaluated whether tumor size, ≤ 0.5 cm or > 0.5 cm, had a significant impact in determining the extent of surgery in patients with PTMC.
Detailed description
Study population From March 1986 to December 2006, a total of 5042 patients with PTC (of all tumor sizes) underwent initial surgical therapy at our institution. Of these, 2441 patients (48.4%) had PTMCs ≤ 1 cm in diameter, with 1270 undergoing TT and 1171 undergoing LT. Complete follow-up data for major clinical events were available for 2014 patients (82.5%), including 1015 (79.9%) of the TT group and 999 (85.3%) of the LT group (p=0.083). Patients were followed-up for a median 11.8 years (range, 5 to 26 years). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria. The study protocol was approved by our Institutional Review Board. Details of patients' presentations, surgical and pathologic findings, and adjunctive treatments were obtained from the Yonsei University Thyroid Cancer Database.
Management strategy In patients diagnosed with PTMC after a complete radiologic and histologic examination, the extent of thyroidectomy and radioactive iodine (RI) therapy were based on prognostic factors. However, the protocol of our institution as to how PTMC should be appropriately managed has been changed according to update of clinical reports and validated treatment guidelines. Therefore, the lack of a standardized approach during the study period allowed us to assess the impact of various therapeutic modalities, especially extent of thyroidectomy, in patients with PTMC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We evaluated 2014 patients with PTMC who underwent TT (n=1015) or LT (n=999) between March 1986 and December 2006 and for whom complete follow-up data were available for at least 5 years (median 11.8 years; range 5-26 years).
Key inclusion criteria (1 listed)
- From March 1986 to December 2006, a total of 5042 patients with PTC (of all tumor sizes) underwent initial surgical therapy at our institution. Of these, 2441 patients (48.4%) had PTMCs ≤1 cm in diameter, with 1270 undergoing TT and 1171 undergoing LT. Complete follow-up data for major clinical events were available for 2014 patients (82.5%), including 1015 (79.9%) of the TT group and 999 (85.3%) of the LT group (p=0.083). All histopathologic diagnoses were reviewed and verified by endocrine pathologists using WHO criteria.
Key exclusion criteria (1 listed)
- Patients with follow-up loss
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
Overall survival in patients with papillary thyroid microcarcinoma
Time frame: Overall survival (10-year)
We analyzed overall survival in patients with PTMC. We also compared the overall survival between total thyroidectomy group versus less than total thyroidectomy group. Survival curves were constructed using the Kaplan-Meier method and compared using the log-rank test.
1 secondary outcome
Disease-free survival in patients with papillary thyroid microcarcinoma
Time frame: Disease-free survival (10-year)
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 24 Jul 2012.
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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.
Woong Youn Chung study chair
Yonsei University
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 Papillary Thyroid Microcarcinoma, run by Korean Association of Endocrine Surgeons at 1 site in South Korea.
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 24 Jul 2012. 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 South Korea. 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?
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?
Overall survival in patients with papillary thyroid microcarcinoma (time frame: Overall survival (10-year)). 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 24 Jul 2012.