Recurrence in Patients With Differentiated Thyroid Cancer

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06154863
Collaborator
(none)
100
24.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer
Anticipated Study Start Date :
Dec 25, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer. [2 years]

    Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.

Secondary Outcome Measures

  1. Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant. [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.

Other Outcome Measures

  1. Assessment of Prognostic significance of pathological data post thyroidectomy in thyroid cancer. [2 years]

    Assessment of Prognostic significance of pathological data post thyroidectomy in patients with differentiated thyroid cancer.

  2. Assessment of Prognostic significance of anti-thyroglobulin level in differentiated thyroid cancer. [2 years]

    Assessment of Prognostic significance of anti-thyroglobulin level in follow up of patients with differentiated thyroid cancer patients.

  3. Assessment of Prognostic significance of thyroglobulin level in differentiated thyroid cancer. [2 years]

    Assessment of Prognostic significance of thyroglobulin level in follow up of patients with differentiated thyroid cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sara Salah Mahmoud, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06154863
Other Study ID Numbers:
  • recurrence in thyroid cancer
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023