NCT07042984Not yet recruiting
RET-US Study - Ultrasound-Based Prediction of RET Alterations and Lateral-Neck Metastasis in Thyroid Cancer
RET-US Cohort: Prospective Evaluation of an AI-Ultrasound Model for Detecting RET Gene Alterations and Predicting Lateral Cervical Lymph-Node Metastasis in Papillary Thyroid Carcinoma
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Why is this study being done? RET gene alterations occur in only 5-10 % of papillary thyroid cancers, but they can change how surgeons treat the disease. Gene testing is costly and not always performed, so many RET-positive tumours are missed. Researchers have built a computer program (artificial-intelligence or "AI" model) that reads routine thyroid ultrasound images and predicts whether the tumour carries a RET alteration and whether the cancer has already spread to lymph-nodes in the side of the neck. What will happen in this study? About 800 adults who are scheduled for thyroid-cancer surgery will take part. Each participant will: * have a standard pre-operative ultrasound exam (no extra scanning time), * give a routine fine-needle sample for a 14-gene panel test (results in 24 h), and * allow the AI model to analyse the ultrasound images in the background. Doctors making treatment decisions will not see the AI result. After surgery, the research team will compare the AI predictions with the gene-panel result and the final pathology report. Main goal: To find out how accurately the AI model detects RET alterations. Secondary goals: To measure the model's ability to predict lymph-node spread, and to compare costs between ultrasound-only prediction and full gene testing. Benefits and risks: Participants will receive the current standard of care; there is no added risk beyond the usual ultrasound and needle biopsy. The study could lead to faster, less expensive ways to identify high-risk thyroid cancers in the future.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 21 Jun 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- Fujian Medical University
- Diseases
- Thyroid cancer
- NCT number
- NCT07042984
What you commit to
- Study type: Observational
- Planned participants: 800
- From 1 Jul 2025 to the primary completion date, 31 Jul 2029
- 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
- Prior thyroid or major neck surgery.
Other illness
- Known medullary thyroid carcinoma, anaplastic carcinoma, or metastatic disease outside the neck.
- Multiple endocrine neoplasia (MEN) syndromes or clinical suspicion of multi-gland disease.
Lab values
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or other condition that precludes surgery or gene testing.
Other
- Pregnant or breastfeeding.
Who the study is looking for
- Age 18-75 years, able to provide written informed consent.
- Pre-operative ultrasound findings highly suggestive of papillary thyroid carcinoma.
- Planned thyroidectomy (any extent) at a participating institution.
- Willing to undergo rapid 11-gene next-generation sequencing (NGS) panel and allow use of ultrasound DICOM images for AI analysis.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.