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OpenTrials
Completed

NCT Number: NCT06437873

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

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).

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total Thyroidectomy (TT)

Procedure

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.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 10 years post-diagnosis

    Time from diagnosis until death from any cause.

  2. Cancer-Specific Survival (CSS)

    Time frame: Up to 10 years post-diagnosis

    Time from diagnosis to death specifically from follicular thyroid carcinoma.

Sponsors and collaborators

Lead sponsor

Dezhou Hospital Qilu Hospital of Shandong University

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2020
Study completion
2024
First posted
May 31, 2024
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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