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NCT Number: NCT05754892

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

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sample

Other

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

Urine sample

Other

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

Tumor sample

Other

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

Primary outcomes

  1. Baseline biomarkers results

    Time frame: Within 3 months after surgery

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery

Secondary outcomes

  1. M3 biomarkers results

    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

  2. M6 biomarkers results

    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

  3. M9 biomarkers results

    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

  4. M12 biomarkers results

    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

  5. M15 biomarkers results

    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

  6. M18 biomarkers results

    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

  7. M21 biomarkers results

    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

  8. M24 biomarkers results

    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

  9. M27 biomarkers results

    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

  10. M30 biomarkers results

    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

  11. M33 biomarkers results

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle AUGER, Chef de projet

CONTACT

[email protected]

01 58 41 11 86

Guillaume Assie, Pr

CONTACT

[email protected]

01 58 41 18 20

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • National Cancer Institute, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: COMETE-CARE

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Mar 6, 2023
Registry last updated
Mar 27, 2026

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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