The Role of Trop2 in Radioactive Iodine-131 Therapy Sensitivity in Papillary Thyroid Carcinoma

NCT07314255 | Active Not Recruiting

• 2 other identifiers: Trop2 and PTC202211013
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Clinincal data and pathological specimens from patients who had undergone at least one radioactive iodine-131 (\^131I) therapy in the Department of Nuclear Medicine at Jiangxi Cancer Hospital over the past 8-10 years were retrospectively collected (approximately 30-50 cases each in the \^131I treatment-responsive group vs. the \^131I treatment-resistant group). Patients in the \^131I treatment-resistant group underwent \^18F-Trop2 PET-CT imaging. Inclusion criteria:

1. 1.History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC);
2. 2.At least one course of \^131I internal radiotherapy.
3. 3.Presence of other severe comorbidities;
4. 4.Incomplete clinical or follow-up data. The clinicopathological characteristics and Trop2 expression levels in tissue samples were compared between the \^131I treatment-responsive group and the \^131I treatment-resistant group.

Conditions

PTC; I-131; Trop2

Outcome Measures

Primary Outcomes (1)

• Tumor size;

  Lesion size was determined using CT imaging. Lymph nodes were assessed based on their shortest diameter, while other target lesions were evaluated based on their longest diameter. Each measurable lesion underwent an average measurement derived from a minimum of three readings, with all measurements conducted by the same individual to minimize measurement discrepancies. Response Evaluation Criteria in Solid Tumors (RECIST 1.1) were used to assess treatment response

  6-60 months

Secondary Outcomes (1)

• Serological assessment

  1-60months

Study Arms (2)

RAI responder

The ¹³¹I treatment-responsive group was defined as patients who achieved successful radioactive iodine therapy (i.e., lesions disappeared or showed no long-term progression after radioiodine uptake).

Radiation: radioiodine-131 therapy

RAI nonresponder

The ¹³¹I treatment-resistant group was defined as patients meeting any of the following criteria: No radioiodine uptake in metastatic tissues during the first ¹³¹I treatment, with insignificant decrease or an increase in serum Tg levels before and after therapy; Partial lesions exhibit radioiodine uptake while others showed no uptaking; Progressive metastatic disease despite evident radioiodine uptake.

Radiation: radioiodine-131 therapy

Interventions

radioiodine-131 therapy RADIATION

surgery, tsh inhibition therapy

RAI nonresponder; RAI responder

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients who had undergone total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma and at least one radioactive iodine-131 (\^131I) therapy in the Department of Nuclear Medicine at Jiangxi Cancer Hospital over the past 8-10 years were retrospectively collected

Sponsors & Collaborators

• Jiangxi Provincial Cancer Hospital: lead
• Lin Zhou: collaborator
• Zhijun Chen: collaborator
• Yu Su: collaborator
• Jingxiu Zhong: collaborator
• Tianzhu Lu: collaborator

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Postoperative paraffin-embedded specimens

Study Officials

• lin zhou

  Jiangxi Provincial Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)