Follicular Thyroid CancerNCT06437873
Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 FTC
An observational study of Follicular Thyroid Cancer and SEER Database Analysis, run by Dezhou Hospital Qilu Hospital of Shandong University.
Trial summary
This study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine… Read more about this study
- Who is it for?
- Ages 5 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Follicular Thyroid Cancer, SEER Database Analysis
- What is being tested?
- Total Thyroidectomy (TT) and Radioactive iodine treatment(RAIT)
- Type of treatment
- Surgery or procedure
- How many people
- 2,957 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 25 May 2024
- 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 5 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The SEER database was established in 1973, serves as a public database and research resource developed by the National Cancer Institute (NCI) of the United States. It encompasses data covering approximately 30% of the U.S. population. The dataset for this retrospective study was obtained from the SEER Research Data, encompassing information from 17 registries as of November 2022, which includes cases recorded between the years 2000 and 2020.
Inclusion Criteria:1.The primary site code C73.9, denoting the thyroid gland;2.The International Classification of Diseases for Oncology, Third Edition (ICD-O-3) histology types comprising 8330 (Follicular adenocarcinoma, NOS), 8331 (Follicular adenocarcinoma well differentiated), 8332 (Follicular adenocarcinoma trabecular), 8335 (Follicular carcinoma, minimally invasive), and 8339 (Follicular thyroid carcinoma (FTC), encapsulated angioinvasive).
Exclusion Criteria:(1). Absence of T stage information or designation as T1, T2; (2). Missing surgery codes; (3). Cases not verified by histopathological analysis; (4). FTC not being the initial malignancy diagnosed in the patient; (5). Unknown survival duration or survival less than one month; (6). Presence of bilateral tumors.
About this study
Official title: Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 Follicular Thyroid Carcinoma:A Retrospective Propensity Score-Matched Study
This study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine therapy (RAIT) on the survival of patients without TT. Utilizing the SEER database, a retrospective study identified patients diagnosed with T3 or T4 FTC, categorizing them into two cohorts: those treated with TT and those who were not (No-TT). The No-TT group was further analyzed to determine the impact of RAIT on patient survival. Propensity score matching (PSM) was applied to adjust for confounding variables. Survival analysis, including Kaplan-Meier survival curves and Landmark analysis, was conducted to evaluate the effects of surgical intervention and RAIT on overall survival (OS) and cancer-specific survival (CSS).
- Conditions
- Follicular Thyroid Cancer, SEER Database Analysis
- Being tested
- Total Thyroidectomy (TT), Radioactive iodine treatment(RAIT)
- Keywords
- Retrospective analysis, follicular thyroid carcinoma, total thyroidectomy, long-term survival outcomes.
- Medical subject headings
- Adenocarcinoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Thyroidectomy (TT)Procedure or surgery
TT:Surgical removal of the entire thyroid gland.
Radioactive iodine treatment(RAIT)Radiation
RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| Total Thyroidectomy (TT) Group | Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy Receives: Procedure: Total Thyroidectomy (TT) | |
| No Total Thyroidectomy (No-TT) Group | Patients with T3 or T4 stage follicular thyroid carcinoma who did not undergo total thyroidectomy. | |
| Radioactive Iodine Therapy (RAIT) Group | Patients in the No-TT group who received radioactive iodine therapy. Receives: Radiation: Radioactive iodine treatment(RAIT) | |
| No Radioactive Iodine Therapy (No-RAIT) Group | Patients in the No-TT group who did not receive radioactive iodine therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from diagnosis until death from any cause.
Measured: Up to 10 years post-diagnosis
Cancer-Specific Survival (CSS)
Time from diagnosis to death specifically from follicular thyroid carcinoma.
Measured: Up to 10 years post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2020
- Study completion25 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Follicular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dezhou Hospital Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Zhang, MD, Study director, Dezhou Hospital Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437873
- Sponsor's protocol ID
- DezhouH_2024_001
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared with researchers upon reasonable request.
Publications
Daniels GH. Follicular Thyroid Carcinoma: A Perspective. Thyroid. 2018 Oct;28(10):1229-1242. doi: 10.1089/thy.2018.0306. Epub 2018 Aug 21. No abstract available.
PubMed 30039751Barbesino G, Goldfarb M, Parangi S, Yang J, Ross DS, Daniels GH. Thyroid lobe ablation with radioactive iodine as an alternative to completion thyroidectomy after hemithyroidectomy in patients with follicular thyroid carcinoma: long-term follow-up. Thyroid. 2012 Apr;22(4):369-76. doi: 10.1089/thy.2011.0198. Epub 2012 Mar 2.
PubMed 22385290Bal C, Satapathy S, Tupalli A, Ballal S. Propensity Score Matched Outcome Analysis of Lobar Ablation Versus Completion Thyroidectomy in Low-Risk Differentiated Thyroid Cancer Patients: Median Follow-Up of 11 Years. Thyroid. 2022 Oct;32(10):1220-1228. doi: 10.1089/thy.2022.0234. Epub 2022 Sep 22.
PubMed 35983596Choi JB, Lee SG, Kim MJ, Kim TH, Ban EJ, Lee CR, Lee J, Kang SW, Jeong JJ, Nam KH, Chung WY, Park CS. Oncologic outcomes in patients with 1-cm to 4-cm differentiated thyroid carcinoma according to extent of thyroidectomy. Head Neck. 2019 Jan;41(1):56-63. doi: 10.1002/hed.25356. Epub 2018 Dec 10.
PubMed 30536465Sugino K, Nagahama M, Kitagawa W, Ohkuwa K, Uruno T, Matsuzu K, Suzuki A, Tomoda C, Hames KY, Akaishi J, Masaki C, Ito K. Risk Stratification of Pediatric Patients with Differentiated Thyroid Cancer: Is Total Thyroidectomy Necessary for Patients at Any Risk? Thyroid. 2020 Apr;30(4):548-556. doi: 10.1089/thy.2019.0231. Epub 2020 Mar 11.
PubMed 31910105
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 Follicular Thyroid Carcinoma:A Retrospective Propensity Score-Matched Study
- ClinicalTrials.gov ID
- NCT06437873
- Acronym / sponsor ID
- DezhouH_2024_001
- Conditions
- Follicular Thyroid Cancer, SEER Database Analysis
- Keywords
- Retrospective analysis, follicular thyroid carcinoma, total thyroidectomy, long-term survival outcomes.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,957 participants (actual)
- Lead sponsor
- Dezhou Hospital Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 25 May 2024 (actual)
- First posted
- 31 May 2024 (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 study aims to thoroughly examine survival disparities in patients with T3 or T4 stage follicular thyroid carcinoma (FTC) as classified by the AJCC staging system. It compares outcomes between those who underwent total thyroidectomy (TT) and those who did not, and assesses the influence of radioactive iodine therapy (RAIT) on the survival of patients without TT. Utilizing the SEER database, a retrospective study identified patients diagnosed with T3 or T4 FTC, categorizing them into two cohorts: those treated with TT and those who were not (No-TT). The No-TT group was further analyzed to determine the impact of RAIT on patient survival. Propensity score matching (PSM) was applied to adjust for confounding variables. Survival analysis, including Kaplan-Meier survival curves and Landmark analysis, was conducted to evaluate the effects of surgical intervention and RAIT on overall survival (OS) and cancer-specific survival (CSS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total Thyroidectomy (TT) Group | – | Procedure: Total Thyroidectomy (TT)Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy |
| No Total Thyroidectomy (No-TT) Group | – | –Patients with T3 or T4 stage follicular thyroid carcinoma who did not undergo total thyroidectomy. |
| Radioactive Iodine Therapy (RAIT) Group | – | Radiation: Radioactive iodine treatment(RAIT)Patients in the No-TT group who received radioactive iodine therapy. |
| No Radioactive Iodine Therapy (No-RAIT) Group | – | –Patients in the No-TT group who did not receive radioactive iodine therapy. |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The SEER database was established in 1973, serves as a public database and research resource developed by the National Cancer Institute (NCI) of the United States. It encompasses data covering approximately 30% of the U.S. population. The dataset for this retrospective study was obtained from the SEER Research Data, encompassing information from 17 registries as of November 2022, which includes cases recorded between the years 2000 and 2020.
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 |
|---|---|---|
| Total Thyroidectomy (TT)TT:Surgical removal of the entire thyroid gland. | Procedure or surgery | Total Thyroidectomy (TT) Group |
| Radioactive iodine treatment(RAIT)RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells. | Radiation | Radioactive Iodine Therapy (RAIT) Group |
Primary outcome
Overall Survival (OS)
Time frame: Up to 10 years post-diagnosis
Time from diagnosis until death from any cause.
Cancer-Specific Survival (CSS)
Time frame: Up to 10 years post-diagnosis
Time from diagnosis to death specifically from follicular thyroid carcinoma.
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 31 May 2024.
- Background: PubMed 30039751Daniels GH. Follicular Thyroid Carcinoma: A Perspective. Thyroid. 2018 Oct;28(10):1229-1242. doi: 10.1089/thy.2018.0306. Epub 2018 Aug 21. No abstract available.
- Background: PubMed 22385290Barbesino G, Goldfarb M, Parangi S, Yang J, Ross DS, Daniels GH. Thyroid lobe ablation with radioactive iodine as an alternative to completion thyroidectomy after hemithyroidectomy in patients with follicular thyroid carcinoma: long-term follow-up. Thyroid. 2012 Apr;22(4):369-76. doi: 10.1089/thy.2011.0198. Epub 2012 Mar 2.
- Background: PubMed 35983596Bal C, Satapathy S, Tupalli A, Ballal S. Propensity Score Matched Outcome Analysis of Lobar Ablation Versus Completion Thyroidectomy in Low-Risk Differentiated Thyroid Cancer Patients: Median Follow-Up of 11 Years. Thyroid. 2022 Oct;32(10):1220-1228. doi: 10.1089/thy.2022.0234. Epub 2022 Sep 22.
- Background: PubMed 30536465Choi JB, Lee SG, Kim MJ, Kim TH, Ban EJ, Lee CR, Lee J, Kang SW, Jeong JJ, Nam KH, Chung WY, Park CS. Oncologic outcomes in patients with 1-cm to 4-cm differentiated thyroid carcinoma according to extent of thyroidectomy. Head Neck. 2019 Jan;41(1):56-63. doi: 10.1002/hed.25356. Epub 2018 Dec 10.
- Background: PubMed 31910105Sugino K, Nagahama M, Kitagawa W, Ohkuwa K, Uruno T, Matsuzu K, Suzuki A, Tomoda C, Hames KY, Akaishi J, Masaki C, Ito K. Risk Stratification of Pediatric Patients with Differentiated Thyroid Cancer: Is Total Thyroidectomy Necessary for Patients at Any Risk? Thyroid. 2020 Apr;30(4):548-556. doi: 10.1089/thy.2019.0231. Epub 2020 Mar 11.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared with researchers upon reasonable request.
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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.
Tao Zhang, MD study director
Dezhou Hospital Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
An observational study of Follicular Thyroid Cancer and SEER Database Analysis, run by Dezhou Hospital Qilu Hospital of Shandong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 May 2024. 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?
Overall Survival (OS) (time frame: Up to 10 years post-diagnosis). 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 NCT06437873, which also lists 5 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 31 May 2024.