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

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood sample: 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: 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: For patients with ACC and patients with MPP : tumor sample during surgery

Study 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

Primary outcome measure(s)

• Baseline biomarkers results — Within 3 months after surgery
  Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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