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

Sponsor: Assistance Publique - Hôpitaux de Paris • ClinicalTrials.gov ID: NCT05754892

Registry updated: 2026-10-05
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Description

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

Interventions

  • Blood sample (Other)
    For patients with ACC : blood (30ml) sampling before surgery and every 3 months during 3 years after surgery for biobanking For patients with MPP : blood (30ml) sampling before surgery and every 6 to 12 months for MPP during 3 years after surgery for biobanking
  • Urine sample (Other)
    For patients with ACC : urine sampling before surgery and every 3 months during 3 years after surgery for biobanking For patients with MPP : urine sampling before surgery and every 6 to 12 months for MPP during 3 years after surgery for biobanking
  • Tumor sample (Other)
    For patients with ACC and patients with MPP : tumor sample during surgery

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)

Conditions

Cancer Adrenal

Locations

  • GH Paris Centre, Assistance Publique - Hôpitaux de Paris — Paris, France
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record