NCT05754892 Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
| NCT ID | NCT05754892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2023-10-01 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Contact & Investigator
Anne JOUINOT, Dr
STUDY DIRECTOR
APHP
Frequently Asked Questions
Who can join the NCT05754892 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05754892 currently recruiting?
Yes, NCT05754892 is actively recruiting participants. Contact the research team at guillaume.assie@aphp.fr for enrollment information.
Where is the NCT05754892 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05754892 clinical trial?
NCT05754892 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Anne JOUINOT, Dr at APHP. The trial plans to enroll 450 participants.
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