GH Paris Centre, Assistance Publique - Hôpitaux de Paris
Paris, 75014, France
Location status: Recruiting
Location contact
Christelle AUGER, Chef de projet
CONTACT
Guillaume ASSIE, Pr
CONTACT
NCT Number: NCT05754892
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Paris, 75014, France
Location status: Recruiting
Christelle AUGER, Chef de projet
CONTACT
Guillaume ASSIE, Pr
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
For patients with ACC and patients with MPP : tumor sample during surgery
Time frame: Within 3 months after surgery
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery
Time frame: During follow-up (month 6)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit
Time frame: During follow-up (month 9)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit
Time frame: During follow-up (month 12)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit
Time frame: During follow-up (month 15)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit
Time frame: During follow-up (month 18)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M18 follow-up visit
Time frame: During follow-up (month 21)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M21 follow-up visit
Time frame: During follow-up (month 24)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M24 follow-up visit
Time frame: During follow-up (month 27)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M27 follow-up visit
Time frame: During follow-up (month 30)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M30 follow-up visit
Time frame: During follow-up (month 33)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M33 follow-up visit
Time frame: During follow-up (month 36)
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M36 follow-up visit
Contact information is provided by the study sponsor or research team.
Christelle AUGER, Chef de projet
CONTACT
Guillaume Assie, Pr
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: COMETE-CARE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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