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

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

NCT ID: NCT05754892

Condition: Cancer
Adrenal

Conditions: Official terms:
Adrenal Gland Neoplasms

Conditions: Keywords:
biological markers
genomics

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Blood sample
Description: 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
Arm group label: Patients with ACC
Arm group label: Patients with MPP

Intervention type: Other
Intervention name: Urine sample
Description: 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
Arm group label: Patients with ACC
Arm group label: Patients with MPP

Intervention type: Other
Intervention name: Tumor sample
Description: For patients with ACC and patients with MPP : tumor sample during surgery
Arm group label: Patients with ACC
Arm group label: Patients with MPP

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)

Detailed description: - 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria - Patients 18 years of age and older - Patients with an adrenal tumor who will be operated of a potentially malignant adrenocortical carcinoma (ACC) 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)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: GH Paris Centre, Assistance Publique - Hôpitaux de Paris

Address:
City: Paris
Zip: 75014
Country: France

Status: Recruiting

Contact:
Last name: Guillaume ASSIE, Pr

Phone: 01 58 41 18 20
Email: guillaume.assie@aphp.fr

Contact backup:
Last name: Christelle AUGER, Chef de projet

Phone: 01 58 41 11 86
Email: christelle.auger@aphp.fr

Start date: October 1, 2023

Completion date: June 2030

Lead sponsor:
Agency: Assistance Publique - Hôpitaux de Paris
Agency class: Other

Collaborator:
Agency: National Cancer Institute, France
Agency class: Other

Source: Assistance Publique - Hôpitaux de Paris

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05754892