About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Vulnerable populations : minors, pregnant or breastfeeding women, protected adults
Patients on AME (state medical aid)
Trial design
Parallel
Treatments tested in this trial
Blood sample
Other interventionFor 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 interventionFor 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 interventionFor patients with ACC and patients with MPP : tumor sample during surgery
Treatment groups
Trial outcomes
Primary outcomes
Baseline biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery
Secondary outcomes
M3 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit
M6 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit
M9 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit
M12 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
National Cancer Institute, France
Collaborator
URC-CIC Paris Descartes Necker Cochin
Collaborator