Recurrence in Patients With Differentiated Thyroid Cancer

February 16, 2024 updated by: Sara Salah Mahmoud, Assiut University

Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer

The aim of this study is to assess the recurrence-free survival (RFS) rate and recurrence-related factors, especially the relationship between RFS and RAI dose, in patients who received RAI after thyroidectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid cancer is the most frequent cancer of the endocrine system, and its incidence is constantly rising worldwide. This is mainly because of advances in examination modalities that have made it possible to detect smaller cancers at an early stage.

Owing to advancements in screening techniques and treatment methods, the number of patients who die from thyroid cancer is small compared to the incidence.[1]

The most common type of thyroid cancer is differentiated thyroid cancer (DTC), which includes papillary and follicular carcinomas. Women are three times more likely to develop thyroid cancer than men. [2] Adjuvant RAI131 (AT) is recommended post thyroidectomy, because of its therapeutic impact on micro-invasions or micro-metastases, to reduce the likelihood of recurrence in patients who do not have metastases but have risk of recurrence according to the Japanese guidelines and American Thyroid Association guidelines [3],[4].

AT could prolong the survival of patients with intermediate-risk DTC [5]. Additionally, a meta-analysis has shown that AT is effective in reducing recurrence in some studies but not in others, and the effect of AT on recurrence prevention, especially in high-risk DTC, remains unclear.[6].

Although there are reliable reports discussing the relationship between the success or failure of remnant ablation [7],[8], recurrence after AT is rarely reported and the number of cases is small. In addition, no study has so far discussed the relationship between the success or failure of AT or remnant ablation and recurrence or death [9],[10].

Study Type

Observational

Enrollment (Estimated)

100

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

N/A

Sampling Method

Probability Sample

Study Population

patients with differentiated thyroid cancer underwent total thyroidectomy.

Description

Inclusion Criteria:

  • Patients with DTC (differentiated thyroid cancer) who underwent total or subtotal thyroidectomy without distant metastasis and gross residual tumors.
  • Followed by ablation with RAI and underwent post RAI whole body scan.
  • Having baseline TG (thyroglobulin), Anti-TG antibodies (anti thyroglobulin) and neck US.
  • Patients with lymph node metastasis will be included if their lymph nodes had been dissected and no unresectable disease remained.

Exclusion Criteria:

  • Patients who received RAI and missed follow-up.
  • Patients with no surgical or pathological data.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.
Time Frame: 2 years
Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.
Time Frame: 2 years
Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant in patients with low-intermediate-risk differentiated thyroid cancer.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Prognostic significance of pathological data post thyroidectomy in thyroid cancer.
Time Frame: 2 years
Assessment of Prognostic significance of pathological data post thyroidectomy in patients with differentiated thyroid cancer.
2 years
Assessment of Prognostic significance of anti-thyroglobulin level in differentiated thyroid cancer.
Time Frame: 2 years
Assessment of Prognostic significance of anti-thyroglobulin level in follow up of patients with differentiated thyroid cancer patients.
2 years
Assessment of Prognostic significance of thyroglobulin level in differentiated thyroid cancer.
Time Frame: 2 years
Assessment of Prognostic significance of thyroglobulin level in follow up of patients with differentiated thyroid cancer.
2 years

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 22, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • recurrence in thyroid cancer

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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