RecruitingNot ApplicableNCT05754892

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

450 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (COMETE-CARE) is evaluating molecular markers in the blood and tumor tissue of patients with adrenal gland tumors — including adrenocortical carcinoma and pheochromocytoma — to see if these markers can improve diagnosis, predict outcomes, and guide treatment decisions. **You may be eligible if...** - You are 18 or older - You have an adrenal tumor that will be surgically removed, suspected or confirmed to be a potentially malignant type (adrenocortical carcinoma, pheochromocytoma, or paraganglioma) - You are covered by French social security - You have given informed consent **You may NOT be eligible if...** - You are a minor (under 18) - You are pregnant or breastfeeding - You are on state medical aid (AME) - You are a legally protected adult Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood 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

OTHERUrine 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

OTHERTumor sample

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


Locations(1)

GH Paris Centre, Assistance Publique - Hôpitaux de Paris

Paris, France

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NCT05754892


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