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

NCT ID: NCT07314255

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-18

Study Completion Date

2027-07-01

Brief Summary

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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. History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC);
2. At least one course of \^131I internal radiotherapy.

Exclusion criteria:

1. Presence of other severe comorbidities;
2. 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.

Within the \^131I treatment-resistant group, comparisons were made between the rapidly progressing subgroup and the stable-disease subgroup under TSH-suppressive therapy in terms of clinicopathological features, tissue Trop2 expression levels, and SUVmax of metastatic lesions on \^18F-Trop2 PET-CT imaging. Factors influencing progression-free survival and overall survival in \^131I-resistant patients were analyzed.

Detailed Description

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Conditions

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PTC I-131 Trop2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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).

radioiodine-131 therapy

Intervention Type RADIATION

surgery, tsh inhibition 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.

radioiodine-131 therapy

Intervention Type RADIATION

surgery, tsh inhibition therapy

Interventions

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radioiodine-131 therapy

surgery, tsh inhibition therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:( 1) History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC); (2) At least one course of \^131I internal radiotherapy.

Exclusion Criteria

Exclusion Criteria:(1) Presence of other severe comorbidities; (2) Incomplete clinical or follow-up data.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lin Zhou

UNKNOWN

Sponsor Role collaborator

Zhijun Chen

UNKNOWN

Sponsor Role collaborator

Yu Su

UNKNOWN

Sponsor Role collaborator

Jingxiu Zhong

UNKNOWN

Sponsor Role collaborator

Tianzhu Lu

UNKNOWN

Sponsor Role collaborator

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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lin zhou

Role: PRINCIPAL_INVESTIGATOR

Jiangxi Provincial Cancer Hospital

Locations

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Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Site Status

Countries

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China

Other Identifiers

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202211013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Trop2 and PTC

Identifier Type: -

Identifier Source: org_study_id

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