search
Back to results

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

Primary Purpose

Cancer, Adrenal

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Urine sample
Tumor sample
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer focused on measuring biological markers, genomics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • GH Paris Centre, Assistance Publique - Hôpitaux de Paris

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with ACC

Patients with MPP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

M3 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit
M6 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit
M9 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit
M12 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit
M15 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M18 follow-up visit
M18 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M21 follow-up visit
M21 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M24 follow-up visit
M24 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M27 follow-up visit
M27 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M30 follow-up visit
M30 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M33 follow-up visit
M33 biomarkers results
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M36 follow-up visit

Full Information

First Posted
December 26, 2022
Last Updated
February 22, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Cancer Institute, France
search

1. Study Identification

Unique Protocol Identification Number
NCT05754892
Brief Title
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
Acronym
COMETE-CARE
Official Title
Positioning of Molecular Markers in Clinical Routine for the Management of Patients With Adrenal Cancers/Tumors (COMETE-CARE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
June 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Adrenal
Keywords
biological markers, genomics

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with ACC
Arm Type
Other
Arm Description
These patients will be followed up and proposed a search for targetable molecular alterations
Arm Title
Patients with MPP
Arm Type
Other
Arm Description
These patients will be followed up and proposed a search for targetable molecular alterations
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention 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
Intervention Type
Other
Intervention Name(s)
Urine sample
Intervention 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
Intervention Type
Other
Intervention Name(s)
Tumor sample
Intervention Description
For patients with ACC and patients with MPP : tumor sample during surgery
Primary Outcome Measure Information:
Title
Baseline biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after initial surgery
Time Frame
Within 3 months after surgery
Secondary Outcome Measure Information:
Title
M3 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M6 follow-up visit
Time Frame
During follow-up (month 6)
Title
M6 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M9 follow-up visit
Time Frame
During follow-up (month 9)
Title
M9 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M12 follow-up visit
Time Frame
During follow-up (month 12)
Title
M12 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M15 follow-up visit
Time Frame
During follow-up (month 15)
Title
M15 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M18 follow-up visit
Time Frame
During follow-up (month 18)
Title
M18 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M21 follow-up visit
Time Frame
During follow-up (month 21)
Title
M21 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M24 follow-up visit
Time Frame
During follow-up (month 24)
Title
M24 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M27 follow-up visit
Time Frame
During follow-up (month 27)
Title
M27 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M30 follow-up visit
Time Frame
During follow-up (month 30)
Title
M30 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M33 follow-up visit
Time Frame
During follow-up (month 33)
Title
M33 biomarkers results
Description
Proportion of biomarkers and of informative biomarkers returned to physicians within 3 months after M36 follow-up visit
Time Frame
During follow-up (month 36)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Assie, Pr
Phone
01 58 41 18 20
Email
guillaume.assie@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle AUGER, Chef de projet
Phone
01 58 41 11 86
Email
christelle.auger@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne JOUINOT, Dr
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
GH Paris Centre, Assistance Publique - Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume ASSIE, Pr
Phone
01 58 41 18 20
Email
guillaume.assie@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christelle AUGER, Chef de projet
Phone
01 58 41 11 86
Email
christelle.auger@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31294750
Citation
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.
Results Reference
background
PubMed Identifier
32412940
Citation
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.
Results Reference
background
PubMed Identifier
35266879
Citation
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.
Results Reference
background
PubMed Identifier
23756429
Citation
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.
Results Reference
background
PubMed Identifier
32711725
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs