Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients 18 years of age and older

• Patients with an adrenal tumor who will be operated of a potentially malignant adrenocortical carcinoma (ACC) or pheochromocytoma or paraganglioma (MPP) (any stage, any secretion)

• Patients affiliated with a social security regime

• Patients who have signed an informed consent

Locations
Other Locations
France
GH Paris Centre, Assistance Publique - Hôpitaux de Paris
RECRUITING
Paris
Contact Information
Primary
Guillaume Assie, Pr
guillaume.assie@aphp.fr
01 58 41 18 20
Backup
Christelle AUGER, Chef de projet
christelle.auger@aphp.fr
01 58 41 11 86
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2030-06
Participants
Target number of participants: 450
Treatments
Other: Patients with ACC
These patients will be followed up and proposed a search for targetable molecular alterations
Other: Patients with MPP
These patients will be followed up and proposed a search for targetable molecular alterations
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris
Collaborators: National Cancer Institute, France

This content was sourced from clinicaltrials.gov