Recurrence in Patients With Differentiated Thyroid Cancer

Differentiated Thyroid Cancer Clinical Trial

Official title:

Evaluation of Recurrence in Patients With Differentiated Thyroid Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154863
• Other study ID #: recurrence in thyroid cancer
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Recurrence
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• RAI
Radioactive iodine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Jeong SY, Lee SW, Kim WW, Jung JH, Lee WK, Ahn BC, Lee J. Clinical outcomes of patients with T4 or N1b well-differentiated thyroid cancer after different strategies of adjuvant radioiodine therapy. Sci Rep. 2019 Apr 3;9(1):5570. doi: 10.1038/s41598-019-42083-3. — View Citation

Lee SH, Roh JL, Gong G, Cho KJ, Choi SH, Nam SY, Kim SY. Risk Factors for Recurrence After Treatment of N1b Papillary Thyroid Carcinoma. Ann Surg. 2019 May;269(5):966-971. doi: 10.1097/SLA.0000000000002710. — View Citation

Ruel E, Thomas S, Dinan M, Perkins JM, Roman SA, Sosa JA. Adjuvant radioactive iodine therapy is associated with improved survival for patients with intermediate-risk papillary thyroid cancer. J Clin Endocrinol Metab. 2015 Apr;100(4):1529-36. doi: 10.1210/jc.2014-4332. Epub 2015 Feb 2. — View Citation

Sawka AM, Carty SE, Haugen BR, Hennessey JV, Kopp PA, Pearce EN, Sosa JA, Tufano RP, Jonklaas J. American Thyroid Association Guidelines and Statements: Past, Present, and Future. Thyroid. 2018 Jun;28(6):692-706. doi: 10.1089/thy.2018.0070. Epub 2018 Apr 26. — View Citation

Vigneri R, Malandrino P, Vigneri P. The changing epidemiology of thyroid cancer: why is incidence increasing? Curr Opin Oncol. 2015 Jan;27(1):1-7. doi: 10.1097/CCO.0000000000000148. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of Prognostic significance of pathological data post thyroidectomy in thyroid cancer.	Assessment of Prognostic significance of pathological data post thyroidectomy in patients with differentiated thyroid cancer.	2 years
Other	Assessment of Prognostic significance of anti-thyroglobulin level in differentiated thyroid cancer.	Assessment of Prognostic significance of anti-thyroglobulin level in follow up of patients with differentiated thyroid cancer patients.	2 years
Other	Assessment of Prognostic significance of thyroglobulin level in differentiated thyroid cancer.	Assessment of Prognostic significance of thyroglobulin level in follow up of patients with differentiated thyroid cancer.	2 years
Primary	Assessment of recurrence-free survival after RAI therapy in patients with thyroid cancer.	Assessment of recurrence-free survival after radioactive iodine-131 therapy in patients with differentiated thyroid carcinoma.	2 years
Secondary	Correlation analysis of I-131 SPECT/CT uptake parameters with the success ablation treatment of thyroid remnant.	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