## Protocol Section
### Identification Module
**NCT ID:** NCT06437873

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

**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

#### Organization Study ID Info
**ID:** DezhouH_2024_001
#### Organization
**Class:** OTHER
**Full Name:** Dezhou Hospital Qilu Hospital of Shandong University
### Status Module
#### Completion Date
**Date:** 2024-05-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2000-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Dezhou Hospital Qilu Hospital of Shandong University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Follicular Thyroid Cancer

- SEER Database Analysis

**Keywords:**

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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 2957

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Procedure: Total Thyroidectomy (TT)

**Label:** Total Thyroidectomy (TT) Group

#### Arm Group 2

**Description:** Patients with T3 or T4 stage follicular thyroid carcinoma who did not undergo total thyroidectomy.

**Label:** No Total Thyroidectomy (No-TT) Group

#### Arm Group 3

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

**Intervention Names:**

- Radiation: Radioactive iodine treatment(RAIT)

**Label:** Radioactive Iodine Therapy (RAIT) Group

#### Arm Group 4

**Description:** Patients in the No-TT group who did not receive radioactive iodine therapy.

**Label:** No Radioactive Iodine Therapy (No-RAIT) Group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Total Thyroidectomy (TT) Group

**Description:** TT:Surgical removal of the entire thyroid gland.

**Name:** Total Thyroidectomy (TT)

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Radioactive Iodine Therapy (RAIT) Group

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

**Name:** Radioactive iodine treatment(RAIT)

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Time from diagnosis until death from any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** Up to 10 years post-diagnosis

**Description:** Time from diagnosis to death specifically from follicular thyroid carcinoma.

**Measure:** Cancer-Specific Survival (CSS)

**Time Frame:** Up to 10 years post-diagnosis

### Eligibility Module

**Eligibility 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.

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 5 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Qilu hospital of Shandong University Dezhou hospital

**Name:** Tao Zhang, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**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.

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

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**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.

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M20409

- Name: Adenocarcinoma, Follicular

- Relevance: HIGH

- As Found: Follicular Thyroid Cancer

- ID: M16718

- Name: Thyroid Diseases

- Relevance: HIGH

- As Found: Thyroid

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M16723

- Name: Thyroid Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5650

- Name: Thyroid Cancer, Follicular

- Relevance: HIGH

- As Found: Follicular Thyroid Cancer

### Condition Browse Module - Meshes

- ID: D000018263

- Term: Adenocarcinoma, Follicular

- ID: D000013959

- Term: Thyroid Diseases

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
