Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05754892 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Tumeurs de la surrénale
Tumeurs

Phase

N/A

Promoteur

Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)

Date de début

octobre 2023

Date de fin

juin 2030

Dernière mise à jour

02 avril 2026

Résumé

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

Détail

Voir le détail - Adult patients with a malignant adrenal tumor before initial surgery are proposed to participate to the study. - Initial clinical management following current guidelines is applied, including clinical and morphological evaluation, hormone assays and adrenal surgery. A tumor sample from initial surgery , and a blood sample and a urine sample collected before surgery are included in the current research protocol. These samples are used to run prognostic molecular measurements, in order to classify patients as "low" or "high risk" of recurrence. For ACC samples, paraffin tumor samples will be sent to a centralized pathology facility, where 3' RNA sequencing will be performed on tumor RNA to classify tumors into previously established C1A/C1B prognostic classification. Circulating levels of miRNAs will be assayed from blood samples collected before surgery and used to classify tumors into prognostic categories as previously reported. Urine and plasma steroids profiles will be established using mass spectrometry to classify tumors into prognostic categories as previously reported. For MPP, molecular assays will include somatic genotyping, methylation assays and immunochemistry for the known recurrently altered genes, and used to classify tumors into prognostic categories as previously reported. These molecular results are returned by 3 months after surgery - Patients follow-up is then performed following current guidelines, with repeated visits (each ~3 months for ACC and ~6 months for MPP), including clinical, morphological evaluation, and hormone assays. A blood and a urine sample will also be collected for the current research protocol. These samples will be used to run molecular measurements aiming at identifying early recurrence. For ACC, circulating levels of miRNAs and urine and plasma steroids profiles will be measured every 3 months to classify tumors into prognostic categories as previously reported. For MPP, circulating levels of miRNAs will be measured every 6 months to classify tumors into prognostic categories as previously reported - For patients at high risk of recurrence, a molecular target will be searched by an extended genomic analysis of the tumor (exome sequencing and RNA sequencing), in search for molecular targets that may orient future treatments, if the disease recurs. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY	ASSIE Guillaume	En recrutement IDF	27/12/2025 07:37:28	Contacter
AP-HP Assistance publique - Hôpitaux de Paris		En recrutement IDF	27/12/2025 07:37:26	Contacter
	AP-HP - Hôpital Cochin
	AP-HP - Hôpital Europeen Georges Pompidou
	AP-HP - Hôpital La Pitié-Salpêtrière
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS	Guillaume ASSIE, Pr	En recrutement IDF		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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)

Critère de non inclusion

NCT05754892 - Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)

Informations générales
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Critères
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