Long-term Survival Outcomes of Total Thyroidectomy and Radioactive Iodine Therapy in Unilateral T3/T4 FTC

NCT06437873 | Completed

• 1 other identifier: DezhouH_2024_001
• Study Type: observational
• Target: 2,957
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

Retrospective analysis, follicular thyroid carcinoma, total thyroidectomy, long-term survival outcomes.

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS)

  Time from diagnosis until death from any cause.

  Up to 10 years post-diagnosis

• Cancer-Specific Survival (CSS)

  Time from diagnosis to death specifically from follicular thyroid carcinoma.

  Up to 10 years post-diagnosis

Study Arms (4)

Total Thyroidectomy (TT) Group

Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy

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.

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.

Interventions

Total Thyroidectomy (TT) PROCEDURE

TT:Surgical removal of the entire thyroid gland.

Total Thyroidectomy (TT) Group

Radioactive iodine treatment(RAIT) RADIATION

RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells.

Radioactive Iodine Therapy (RAIT) Group

Eligibility Criteria

• Age: 5 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

Sponsors & Collaborators

• Dezhou Hospital Qilu Hospital of Shandong University: lead

Related Publications (5)

• 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.

  PMID: 30039751 BACKGROUND

• Barbesino 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.

  PMID: 22385290 BACKGROUND

• Bal 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.

  PMID: 35983596 BACKGROUND

• Choi 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.

  PMID: 30536465 BACKGROUND

• Sugino 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.

  PMID: 31910105 BACKGROUND

MeSH Terms

Conditions

Adenocarcinoma, Follicular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Tao Zhang, MD

  Dezhou Hospital Qilu Hospital of Shandong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: January 1, 2000
• Primary Completion: December 31, 2020
• Study Completion: May 25, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months after publication of the main study results and will be accessible for a period of 5 years.
• Access Criteria: Researchers seeking access to the IPD must submit a methodologically sound proposal. Requests should be directed to the principal investigator and will be evaluated on the basis of scientific merit and ethical considerations.