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NCT06530316Recruiting

RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer

The Efficacy and Safety of RET Inhibitor for Neoadjuvant Therapy in Locally Advanced RET-altered Thyroid Cancer: a Real-world Study

Source: ClinicalTrials.gov · Last updated 2 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
48 (estimated)
First submitted
27 Jul 2024
Start date
18 Jul 2024
Primary completion date
31 Dec 2026
Lead sponsor
Fudan University
NCT number
NCT06530316

What you commit to

  • Study type: Observational
  • Planned participants: 48
  • From 18 Jul 2024 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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;
    • 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.

Age in the registry: 14 years to 80 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan Univeristy Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.