Thyroid CancerNCT06530316
RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer
An observational study of Thyroid Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- RET Inhibitor and Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2024to 31 Dec 2029
- 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 14 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with locally advanced thyroid cancer and RET alterations, who require RET inhibitor treatment and surgery after neoadjuvant therapy.
Who may be able to join
- Patients voluntarily join this study and sign an informed consent form;
- Age: ≥ 14 years old, male or female not limited;
- Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc;
- RET alterations, including fusion and mutations;
- The definition of locally advanced thyroid cancer meets at least one of the following criteria:
- Local advanced thyroid cancer with estimated surgical difficulty and inability to R0/1 resection;
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- T4 thyroid cancer defined by AJCC: any size of tumor primary lesion or regional lymph node infiltration beyond the thyroid capsule to subcutaneous soft tissue, larynx, trachea, esophagus, or recurrent laryngeal nerve, tumor invasion of pre vertebral fascia or wrapping around carotid or mediastinal blood vessels;
- According to the imaging score, the resectable probability is less than 80% based on CT.
- At least one measurable lesion;
- For patients with distant metastasis, researchers need to determine whether patients would benefit from surgery;
- Patients voluntarily undergo tumor tissue biopsy/surgery during enrollment and withdrawal;
- Normal function of major organs.
Who cannot join
- Previously used RET inhibitors;
- There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
- The patient refuses to undergo tumor tissue biopsy or surgery;
- Patients who are unsuitable for RET inhibitors or surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Univeristy Shanghai Cancer Center
Shanghai
Yu Wang, M.D., 86-021-64175590 ext. 65805, neck130@hotmail.com
About this study
Official title: The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study
This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- RET Inhibitor, Surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RET InhibitorDrug
RET inhibitors for neoadjuvant treatment
SurgeryProcedure or surgery
Operable patients receive surgery after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| None MTC | DTC, PDTC and ATC patients with RET fusions. Receives: Drug: RET Inhibitor; Procedure: Surgery | |
| MTC | MTC patients with RET mutations Receives: Drug: RET Inhibitor; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0/1 resection rate
Measured: 1 year
Secondary outcomes (6)
Objective Response Rate, ORR
Measured: 1 year
Disease Control Rate，DCR
Measured: 1 year
Time to objective response，TTR
Measured: 1 year
Progression Free Survival，PFS
Measured: 5 years
Overall Survival，OS
Measured: 5 years
Adverse Events
Measured: During RET inhibitor treatment, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start18 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530316
- Sponsor's protocol ID
- PATHYOID
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study
- ClinicalTrials.gov ID
- NCT06530316
- Acronym / sponsor ID
- PATHYOID
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 31 Jul 2024 (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.
This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| None MTC | – | Drug: RET Inhibitor, Procedure: SurgeryDTC, PDTC and ATC patients with RET fusions. |
| MTC | – | Drug: RET Inhibitor, Procedure: SurgeryMTC patients with RET mutations |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced thyroid cancer and RET alterations, who require RET inhibitor treatment and surgery after neoadjuvant therapy.
Key inclusion criteria (12 listed)
- Patients voluntarily join this study and sign an informed consent form;
- Age: ≥ 14 years old, male or female not limited;
- Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc;
- RET alterations, including fusion and mutations;
- The definition of locally advanced thyroid cancer meets at least one of the following criteria:
Key exclusion criteria (4 listed)
- Previously used RET inhibitors;
- There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
- The patient refuses to undergo tumor tissue biopsy or surgery;
- Patients who are unsuitable for RET inhibitors or surgery.
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 |
|---|---|---|
| RET InhibitorRET inhibitors for neoadjuvant treatment | Drug | MTC, None MTC |
| SurgeryOperable patients receive surgery after neoadjuvant therapy | Procedure or surgery | MTC, None MTC |
Primary outcome
R0/1 resection rate
Time frame: 1 year
6 secondary outcomes
Objective Response Rate, ORR
Time frame: 1 year
Disease Control Rate，DCR
Time frame: 1 year
Time to objective response，TTR
Time frame: 1 year
Progression Free Survival，PFS
Time frame: 5 years
Overall Survival，OS
Time frame: 5 years
Adverse Events
Time frame: During RET inhibitor treatment, up to 5 years
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 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Thyroid Cancer, run by Fudan University 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?
The sponsor lists 12 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 2 Aug 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0/1 resection rate (time frame: 1 year). 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 Aug 2024.