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Recruiting NCT05754892

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

Conditions: Cancer, Adrenal

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 450
Sponsor: Assistance Publique - Hôpitaux de Paris

Location: GH Paris Centre, Assistance Publique - Hôpitaux de Paris Paris

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) * Correlation of molecular markers with morphological features (radiological and pathological) of the tumor

Eligibility 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)

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Source: ClinicalTrials.gov (NCT05754892). StuddyBuddy aggregates publicly available trial information.