Monitoring patients with uveal melanoma for liver metastases
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)
This study is testing a special follow-up plan with regular liver scans and blood tests for people with uveal melanoma to see if it helps catch liver cancer spread early.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Curie Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04424719 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with uveal melanoma who are at high risk for metastatic relapse. It involves a tailored follow-up approach that includes regular liver MRI scans and blood tests to identify biomarkers for early diagnosis of liver metastases. Patients will undergo imaging assessments every six months for at least five years, and blood samples will be collected to support biomarker research. The study aims to enhance oncological surveillance based on individual risk factors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high-risk uveal melanoma who have recently completed treatment for their primary tumor.
Not a fit: Patients without French social insurance or those with conditions that hinder participation in the research process may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of liver metastases in uveal melanoma patients, potentially improving treatment outcomes.
How similar studies have performed: While there have been studies focusing on uveal melanoma, this specific approach of personalized risk-adjusted surveillance is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged of 18 years or more. 2. Patient with uveal melanoma with high metastatic relapse risk defined as : * T2b/c/d ou ≥ T3, * or chromosom 3 or chromosom 8 abnormality by CGH array. 3. Completion of treatment of the primary tumor ≤ 2 months. 4. Patient able to comply with the schedule of visits and blood samples of the study. 5. Signed informed consent form or legal representative. Exclusion Criteria: 1. Patient without french social insurance. 2. Any social, medical or psychological condition making the research process impossible.
Where this trial is running
Paris
- Institut Curie — Paris, France (Recruiting)
Study contacts
- Principal investigator: Sophie Piperno-Neumann, MD — Institut Curie
- Study coordinator: Sophie Piperno-Neumann, MD
- Email: sophie.piperno-neumann@curie.fr
- Phone: 01 44 32 46 72
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.