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

May 27, 2024 updated by: Dezhou Hospital Qilu Hospital of Shandong University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total Thyroidectomy (TT) Group
Patients with T3 or T4 stage follicular thyroid carcinoma who underwent total thyroidectomy
Procedure: Total Thyroidectomy (TT)
TT:Surgical removal of the entire thyroid gland.
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)
RAIT:Administration of radioactive iodine to eliminate remaining thyroid tissue or cancer cells.
No Radioactive Iodine Therapy (No-RAIT) Group
Patients in the No-TT group who did not receive radioactive iodine therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 10 years post-diagnosis
Time from diagnosis until death from any cause.
Up to 10 years post-diagnosis
Cancer-Specific Survival (CSS)
Time Frame: Up to 10 years post-diagnosis
Time from diagnosis to death specifically from follicular thyroid carcinoma.
Up to 10 years post-diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dezhou Hospital Qilu Hospital of Shandong University

Investigators

  • Study Director: Tao Zhang, MD, Qilu Hospital of Shandong University Dezhou Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2000

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

May 25, 2024

Study Registration Dates

First Submitted

May 25, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DezhouH_2024_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared with researchers upon reasonable request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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