NCT05754892

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable cancer

Timeline
49mo left

Started Oct 2023

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
Oct 2023Jun 2030

First Submitted

Initial submission to the registry

December 26, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6.2 years

First QC Date

December 26, 2022

Last Update Submit

March 24, 2026

Conditions

CancerAdrenal

Keywords

biological markersgenomics

Outcome Measures

Primary Outcomes (1)

  • Baseline biomarkers results

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

    Within 3 months after surgery

Secondary Outcomes (11)

  • M3 biomarkers results

    During follow-up (month 6)

  • M6 biomarkers results

    During follow-up (month 9)

  • M9 biomarkers results

    During follow-up (month 12)

  • M12 biomarkers results

    During follow-up (month 15)

  • M15 biomarkers results

    During follow-up (month 18)

  • +6 more secondary outcomes

Study Arms (2)

Patients with ACC

OTHER

These patients will be followed up and proposed a search for targetable molecular alterations

Other: Blood sampleOther: Urine sampleOther: Tumor sample

Patients with MPP

OTHER

These patients will be followed up and proposed a search for targetable molecular alterations

Other: Blood sampleOther: Urine sampleOther: Tumor sample

Interventions

Blood sampleOTHER

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

Patients with ACCPatients with MPP
Urine sampleOTHER

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

Patients with ACCPatients with MPP
Tumor sampleOTHER

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

Patients with ACCPatients with MPP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Vulnerable populations : minors, pregnant or breastfeeding women, protected adults
  • Patients on AME (state medical aid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GH Paris Centre, Assistance Publique - Hôpitaux de Paris

Paris, 75014, France

RECRUITING

Related Publications (5)

  • Assie G, Jouinot A, Fassnacht M, Libe R, Garinet S, Jacob L, Hamzaoui N, Neou M, Sakat J, de La Villeon B, Perlemoine K, Ragazzon B, Sibony M, Tissier F, Gaujoux S, Dousset B, Sbiera S, Ronchi CL, Kroiss M, Korpershoek E, De Krijger R, Waldmann J, Quinkler M, Haissaguerre M, Tabarin A, Chabre O, Luconi M, Mannelli M, Groussin L, Bertagna X, Baudin E, Amar L, Coste J, Beuschlein F, Bertherat J. Value of Molecular Classification for Prognostic Assessment of Adrenocortical Carcinoma. JAMA Oncol. 2019 Oct 1;5(10):1440-1447. doi: 10.1001/jamaoncol.2019.1558.

    PMID: 31294750BACKGROUND

  • Lenders JWM, Kerstens MN, Amar L, Prejbisz A, Robledo M, Taieb D, Pacak K, Crona J, Zelinka T, Mannelli M, Deutschbein T, Timmers HJLM, Castinetti F, Dralle H, Widimsky J, Gimenez-Roqueplo AP, Eisenhofer G. Genetics, diagnosis, management and future directions of research of phaeochromocytoma and paraganglioma: a position statement and consensus of the Working Group on Endocrine Hypertension of the European Society of Hypertension. J Hypertens. 2020 Aug;38(8):1443-1456. doi: 10.1097/HJH.0000000000002438.

    PMID: 32412940BACKGROUND

  • Jouinot A, Lippert J, Sibony M, Violon F, Jeanpierre L, De Murat D, Armignacco R, Septier A, Perlemoine K, Letourneur F, Izac B, Ragazzon B, Leroy K, Pasmant E, North MO, Gaujoux S, Dousset B, Groussin L, Libe R, Terris B, Fassnacht M, Ronchi CL, Bertherat J, Assie G. Transcriptome in paraffin samples for the diagnosis and prognosis of adrenocortical carcinoma. Eur J Endocrinol. 2022 Apr 21;186(6):607-617. doi: 10.1530/EJE-21-1228.

    PMID: 35266879BACKGROUND

  • Chabre O, Libe R, Assie G, Barreau O, Bertherat J, Bertagna X, Feige JJ, Cherradi N. Serum miR-483-5p and miR-195 are predictive of recurrence risk in adrenocortical cancer patients. Endocr Relat Cancer. 2013 Jul 5;20(4):579-94. doi: 10.1530/ERC-13-0051. Print 2013 Aug.

    PMID: 23756429BACKGROUND

  • Bancos I, Taylor AE, Chortis V, Sitch AJ, Jenkinson C, Davidge-Pitts CJ, Lang K, Tsagarakis S, Macech M, Riester A, Deutschbein T, Pupovac ID, Kienitz T, Prete A, Papathomas TG, Gilligan LC, Bancos C, Reimondo G, Haissaguerre M, Marina L, Grytaas MA, Sajwani A, Langton K, Ivison HE, Shackleton CHL, Erickson D, Asia M, Palimeri S, Kondracka A, Spyroglou A, Ronchi CL, Simunov B, Delivanis DA, Sutcliffe RP, Tsirou I, Bednarczuk T, Reincke M, Burger-Stritt S, Feelders RA, Canu L, Haak HR, Eisenhofer G, Dennedy MC, Ueland GA, Ivovic M, Tabarin A, Terzolo M, Quinkler M, Kastelan D, Fassnacht M, Beuschlein F, Ambroziak U, Vassiliadi DA, O'Reilly MW, Young WF Jr, Biehl M, Deeks JJ, Arlt W; ENSAT EURINE-ACT Investigators. Urine steroid metabolomics for the differential diagnosis of adrenal incidentalomas in the EURINE-ACT study: a prospective test validation study. Lancet Diabetes Endocrinol. 2020 Sep;8(9):773-781. doi: 10.1016/S2213-8587(20)30218-7. Epub 2020 Jul 23.

    PMID: 32711725BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Anne JOUINOT, Dr

    APHP

    STUDY DIRECTOR

Central Study Contacts

Guillaume Assie, Pr

CONTACT

01 58 41 18 20guillaume.assie@aphp.fr

Christelle AUGER, Chef de projet

CONTACT

01 58 41 11 86christelle.auger@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2022

First Posted

March 6, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)