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

NCT ID: NCT06437873

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2024-05-25

Brief Summary

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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).

Detailed Description

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Conditions

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Follicular Thyroid Cancer SEER Database Analysis

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Total Thyroidectomy (TT) Group

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

Total Thyroidectomy (TT)

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Radioactive Iodine Therapy (RAIT) Group

Patients in the No-TT group who received radioactive iodine therapy.

Radioactive iodine treatment(RAIT)

Intervention Type RADIATION

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.

No interventions assigned to this group

Interventions

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Total Thyroidectomy (TT)

TT:Surgical removal of the entire thyroid gland.

Intervention Type PROCEDURE

Radioactive iodine treatment(RAIT)

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

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dezhou Hospital Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tao Zhang, MD

Role: STUDY_DIRECTOR

Dezhou Hospital Qilu Hospital of Shandong University

References

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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.

Reference Type BACKGROUND
PMID: 30039751 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22385290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35983596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30536465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31910105 (View on PubMed)

Other Identifiers

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DezhouH_2024_001

Identifier Type: -

Identifier Source: org_study_id