Actively Recruiting
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-27
450
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
The adrenal cancer research network "COMETE" is federating French research on rare adrenal cancers. COMETE achieved major breakthroughs in the molecular characterization of adrenocortical carcinomas (ACC) and malignant pheochromocytomas/paragangliomas (MPP). Recently, COMETE successfully derived potential biomarkers for prognosis, theranostic and follow-up. Those biomarkers have been retrospectively validated. However the benefit for patients in real life conditions is not yet established. * Main objective : to implement COMETE biomarkers as a routine standard of care for adrenal cancer. * The primary end point is double : * Proportion of biomarkers results provided within 3 months after surgery, * The proportion of "informative" biomarkers, corresponding to markers passing quality controls and returning a value that is not in the grey zone of the measure. * Secondary objective : to estimate the impact of COMETE biomarkers on patients management. * Secondary endpoints : * Proportion of patients with discrepant clinical and molecular markers ; for discrepancies, proportion of decisions impacted by biomarkers results * Proportion of high risk patients for whom an actionable molecular target was identified * Predictive value (positive and negative) of biomarkers to detect recurrences * Molecular signatures of "extraordinary responders" to treatments (corresponding to the exceptional RECIST complete response, or to the \>80% tumor reduction sutained for \>6months) * Correlation of molecular markers with morphological features (radiological and pathological) of the tumor
CONDITIONS
Official Title
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 carcinoma or pheochromocytoma or paraganglioma
- Patients affiliated with a social security regime
- Patients who have signed an informed consent
You will not qualify if you...
- Minors, pregnant or breastfeeding women, and protected adults
- Patients on state medical aid (AME)
AI-Screening
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Trial Site Locations
Total: 1 location
1
GH Paris Centre, Assistance Publique - Hôpitaux de Paris
Paris, France, 75014
Actively Recruiting
Research Team
G
Guillaume Assie, Pr
CONTACT
C
Christelle AUGER, Chef de projet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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