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Active, not recruitingNCT07314255ZL2025Updated Jan 2, 2026

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

An observational study in PTC, I-131 and Trop2, sponsored by Jiangxi Provincial Cancer Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Jiangxi Provincial Cancer Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • PTC
  • I-131
  • Trop2
03

In context

Lead sponsor

Jiangxi Provincial Cancer Hospital is the lead sponsor of 33 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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

Eligibility 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:(1) Presence of other severe comorbidities; (2) Incomplete clinical or follow-up data.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
60 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Radiationradioiodine-131 therapy

    surgery, tsh inhibition therapy

06

What researchers measure

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

    Time frame: 6-60 months

Secondary outcomes

  1. Serological assessment

    Including serum thyroglobulin (Tg) and serum anti-thyroglobulin antibody levels (TgAb) in thyrotropin-inhibited states, as well as tumor markers such as CEA

    Time frame: 1-60months

07

Study locations

1 site
  • Jiangxi Cancer Hospital
    Nanchang, Jiangxi 330000, China
08

References and documents

Individual participant data

Plan to share: Undecided — We will share our plan after our results be published

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07314255
Lead sponsor
Jiangxi Provincial Cancer Hospital
Collaborators
Lin Zhou, Zhijun Chen, Yu Su, Jingxiu Zhong, Tianzhu Lu
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Dec 18, 2025
Primary completion
Jun 10, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Jan 2, 2026

Study contacts

lin zhou
principal investigator · Jiangxi Provincial Cancer Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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