PTCZL2025NCT07314255
The Role of Trop2 in Radioactive Iodine-131 Therapy Sensitivity in Papillary Thyroid Carcinoma
An observational study of PTC and I-131, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- radioiodine-131 therapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to 1 Jul 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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
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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC);
- At least one course of ^131I internal radiotherapy.
Exclusion criteria:
- Presence of other severe comorbidities;
- 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.
- Being tested
- radioiodine-131 therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radioiodine-131 therapyRadiation
surgery, tsh inhibition therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Radiation: radioiodine-131 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-60months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start18 Dec 2025
- Primary completion10 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lin Zhou, Zhijun Chen, Yu Su, Jingxiu Zhong, Tianzhu Lu
- Responsible party
- Sponsor
- Investigators
- lin zhou, Principal investigator, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314255
- Sponsor's protocol ID
- Trop2 and PTC
- Other IDs
- 202211013
- Acronym
- ZL2025
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share our plan after our results be published
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Trop2 in Radioactive Iodine-131 Therapy Sensitivity in Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT07314255
- Acronym / sponsor ID
- ZL2025 / Trop2 and PTC
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Collaborators
- Lin Zhou, Zhijun Chen, Yu Su, Jingxiu Zhong, Tianzhu Lu
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- History of total thyroidectomy with postoperative pathology confirming papillary thyroid carcinoma (PTC);
- At least one course of ^131I internal radiotherapy.
Exclusion criteria:
- Presence of other severe comorbidities;
- 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAI responder | – | Radiation: radioiodine-131 therapyThe 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). |
| RAI nonresponder | – | Radiation: radioiodine-131 therapyThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radioiodine-131 therapysurgery, tsh inhibition therapy | Radiation | RAI nonresponder, RAI responder |
Primary outcome
Tumor size;
Time frame: 6-60 months
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
1 secondary outcome
Serological assessment
Time frame: 1-60months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided. We will share our plan after our results be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
lin zhou principal investigator
Jiangxi Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTC and I-131, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size; (time frame: 6-60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.