Using molecular markers to improve management of adrenal cancers
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
NA · Assistance Publique - Hôpitaux de Paris · NCT05754892
This study is testing if using specific molecular markers can help doctors better manage treatment for adults with adrenal cancers by predicting their risk of recurrence after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05754892 on ClinicalTrials.gov |
What this trial studies
This study aims to implement the COMETE biomarkers as a standard part of care for patients with adrenal cancers, specifically adrenocortical carcinomas and malignant pheochromocytomas/paragangliomas. Adult patients with malignant adrenal tumors will have tumor, blood, and urine samples collected before surgery to assess prognostic molecular measurements. The study will evaluate the proportion of biomarker results provided within three months post-surgery and the impact of these biomarkers on patient management. The goal is to classify patients based on their risk of recurrence and improve clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a malignant adrenal tumor scheduled for surgery.
Not a fit: Patients who are minors, pregnant or breastfeeding women, or those on state medical aid may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective management of adrenal cancer patients.
How similar studies have performed: Other studies have shown promise in using molecular markers for cancer management, but this specific approach is novel in the context of adrenal cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Patients 18 years of age and older * Patients with an adrenal tumor who will be operated or have been operated in the last 2 months of a potentially malignant adrenocortical (ACC) (any tumor with density \> 10 UH) or pheochromocytoma or paraganglioma (MPP) (any stage, any secretion) * Patients affiliated with a social security regime * Patients who have signed an informed consent Exclusion Criteria * Vulnerable populations : minors, pregnant or breastfeeding women, protected adults * Patients on AME (state medical aid)
Where this trial is running
Paris
- GH Paris Centre, Assistance Publique - Hôpitaux de Paris — Paris, France (RECRUITING)
Study contacts
- Study coordinator: Guillaume Assie, Pr
- Email: guillaume.assie@aphp.fr
- Phone: 01 58 41 18 20
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.
Conditions: Cancer, Adrenal, biological markers, genomics