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CancerCOMETE-CARENCT05754892

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

A study testing Blood sample, Urine sample and Tumor sample in people with Cancer and Adrenal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Adrenal
What is being tested?
Blood sample, Urine sample and Tumor sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteFrance
Study dates
1 Oct 2023to Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guillaume Assie, Pr contact

01 58 41 18 20

guillaume.assie@aphp.fr

Christelle AUGER, Chef de projet contact

01 71 76 07 53

christelle.auger@aphp.fr

France1 site, 1 recruiting
  • GH Paris Centre, Assistance Publique - Hôpitaux de Paris

    Paris, 75014

    Guillaume ASSIE, Pr, 01 58 41 18 20, guillaume.assie@aphp.fr

    Christelle AUGER, Chef de projet, 01 71 76 07 53, christelle.auger@aphp.fr

    Recruiting

Other trials in France

About this study

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
Read the 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.
Conditions
Cancer, Adrenal
Being tested
Blood sample, Urine sample, Tumor sample
Keywords
biological markers, genomics
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • 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

  • Tumor sampleOther

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

Study groups in NCT05754892
Study groupRoleWhat they receive
Patients with ACCOtherThese patients will be followed up and proposed a search for targetable molecular alterations
Receives: Other: Blood sample; Other: Urine sample; Other: Tumor sample
Patients with MPPOtherThese patients will be followed up and proposed a search for targetable molecular alterations
Receives: Other: Blood sample; Other: Urine sample; Other: Tumor sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline biomarkers results

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

    Measured: Within 3 months after surgery

Secondary outcomes (11)
  1. M3 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit

    Measured: During follow-up (month 6)

  2. M6 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit

    Measured: During follow-up (month 9)

  3. M9 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit

    Measured: During follow-up (month 12)

  4. M12 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit

    Measured: During follow-up (month 15)

  5. M15 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M18 follow-up visit

    Measured: During follow-up (month 18)

  6. M18 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M21 follow-up visit

    Measured: During follow-up (month 21)

  7. M21 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M24 follow-up visit

    Measured: During follow-up (month 24)

  8. M24 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M27 follow-up visit

    Measured: During follow-up (month 27)

  9. M27 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M30 follow-up visit

    Measured: During follow-up (month 30)

  10. M30 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M33 follow-up visit

    Measured: During follow-up (month 33)

  11. M33 biomarkers results

    Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M36 follow-up visit

    Measured: During follow-up (month 36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start1 Oct 2023
  3. Primary completionDec 2029 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754892
Sponsor's protocol ID
APHP210350
Other IDs
2022-A00663-40
Acronym
COMETE-CARE
Status last verified
Sep 2026
First submitted
26 Dec 2022
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31294750
  • 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.

    PubMed 32412940
  • 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.

    PubMed 35266879
  • 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.

    PubMed 23756429
  • 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.

    PubMed 32711725

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample, Urine sample and Tumor sample in people with Cancer and Adrenal, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guillaume Assie, Pr (01 58 41 18 20, guillaume.assie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline biomarkers results (time frame: Within 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05754892, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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