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Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card (COMETETACTIC)

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ClinicalTrials.gov Identifier: NCT02672020
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborators:
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
National Cancer Institute, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care.

The main objective of COMETE-TACTIC is to provide an easy-to-use "identity card" of the adrenal tumors that will allow a personalized "à la carte" management of the patient and, when indicated, to the indication of the most accurate molecular targeted therapy.

We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require,

  1. the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers);
  2. the implementation of the translational research projects based on the COMETE collection to identify circulating diagnostic, prognostic and therapeutic genetic and metabolic biomarkers that could be used as non-invasive "liquid biopsies".

Condition or disease Intervention/treatment Phase
Adrenal Gland Neoplasms Biological: omics identity card Not Applicable

Detailed Description:

Malignant pheochromocytoma/paraganglioma (MPP) and adrenocortical carcinoma (ACC) are two rare cancer entities with a very unfavorable prognosis. The knowledge on these rare cancers improved thanks to the French COMETE ('COrtex, MEdulla Tumors Endocrines') network originally based on two clinical centers (HEGP and Cochin) well organized for clinical and biological samples collection. Over the last 10 years, the COMETE key partners deciphered molecular mechanisms of tumorigenesis and oncogenesis of these tumors and identified molecular signatures discriminating between benign and malignant cancers by integrated genomic approaches. COMETE has published more than 200 papers and performed seminal work on the pathophysiology and the genetics of MPP and ACC published in high-impact journals.

This strategy was highly successful in delivering new diagnostic applications of genomics technologies that now appear as potentially suitable for rapid implementation in routine clinical care.

The main objective of COMETE-TACTIC program is to design and validate an easy-to-use "identity card" classifying MPP and ACC in clinical routine, using molecular genomic and metabolomic tools combined with histopathological-based tests, to provide a real help for early diagnosis, prognostic as well as a personalized "à la carte" management and treatment to patients with malignant adrenal tumors. Seven teams, with an expertise in genomics of adrenal tumors, or in metabolomics approaches, or in clinical research and statistical analyses collaborate in COMETE-TACTIC. COMETE-TACTIC will be based on an already constituted large cohort of 850 patients that will be enlarged by the prospective enrolment of new cases and biological samples (300 to 450 new cases during the 3 years of the project) via 21 French expert and/or competence centers of COMETE-Cancer Reference center.

Previous COMETE basic studies provided important new insight for the understanding of molecular mechanisms responsible for MPP or ACC. With the transfer of "Omics"-based tests from research laboratories to clinical practice, COMETE-TACTIC is the next step toward a personalized medicine for patients with MPP and ACC. COMETE-TACTIC should speed the transfer in routine clinical care of new biomarkers based on cutting-edge technologies combining advanced pathology assessment and targeted genomics and metabolomics to diagnose malignancy and predict outcome, and thereby facilitating a more accurate, rapid and reliable diagnostic work-up for patients. This personalized management will help to avoid delayed diagnosis and to direct clinical decisions resulting in a better health outcome for the patients. COMETE-TACTIC will offer the access to a precise molecular classification of MPP and ACC that should guide targeted therapies. Finally, COMETE-TACTIC will investigate for the first time the impact of circulating biomarkers for the diagnosis and prognostic of adrenal cancers that will be further tested as biomarkers of response to targeted therapies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The COMETE Network, Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card
Study Start Date : November 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: patients with adrenal tumor Biological: omics identity card



Primary Outcome Measures :
  1. Malignant status [ Time Frame: Up to 36 months ]
    Number of participants with evidence of metastases



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient operated on a tumor developed from the adrenal cortex or a pheochromocytoma or a paraganglioma
  • Age≥15 years
  • Signature of the informed consent

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672020


Contacts
Contact: Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD 33 1 56 09 38 81 anne-paule.gimenez-roqueplo@aphp.fr
Contact: Laurence AMAR 33 1 56 09 30 63 laurence.amar@aphp.fr

Locations
France
CHU-Angers Recruiting
Angers, France
Principal Investigator: Sandrine LABOUREAU         
Sub-Investigator: Odile BLANCHET         
CHU Rouen-Hopital de Bois-Guillaume Recruiting
Bois-Guillaume, France
Principal Investigator: Herve LEFEBVRE         
Sub-Investigator: Jean-Christophe SABOURIN         
CHU Bordeaux, Hopital du Haut Leveque Recruiting
Bordeaux, France
Principal Investigator: Antoine TABARIN         
Sub-Investigator: Jean-Philippe MERLIO         
CHU Brest, Hopital de la Cavale Blanche Recruiting
Brest, France
Principal Investigator: Emmanuel SONNET         
Sub-Investigator: Laurent DOUCET         
HCL- Centre Hospitalier Lyon Est Recruiting
Bron, France
Principal Investigator: Francoise BORSON-CHAZOT         
Sub-Investigator: Myriam DECAUSSIN-PETRUCCI         
CHU Clermont-Ferrand, Hopital Gabriel Montpied Recruiting
Clermont-Ferrand, France
Principal Investigator: Marie BATISSE-LIGNIER         
Sub-Investigator: Marc BERGER         
CHU Grenoble- Hopital Albert Michallon Recruiting
Grenoble, France
Principal Investigator: Olivier CHABRE         
Sub-Investigator: Pascal MOSSUZ         
Assistance Publique Hopitaux de Pais, Hopital de Bicetre Recruiting
Le Kremlin Bicetre, France
Principal Investigator: Philippe CHANSON         
Sub-Investigator: Catherine GUETTIER-BOUTTIER         
CHU Limoges, Hopital du Cluzeau Recruiting
Limoges, France
Principal Investigator: Francoise ARCHAMBEAUD         
Sub-Investigator: Francois LABROUSSE         
CHU Montpellier, Hopital Lapeyronie Recruiting
Montpellier, France
Principal Investigator: Flora FASSIO         
Sub-Investigator: Valerie RIGAU         
CHU Nantes, Hopital Laënnec Recruiting
Nantes, France
Principal Investigator: Delphine DRUI         
Sub-Investigator: Geraldine GALLOT         
Assistance Publique Hopitaux de Paris -HEGP Recruiting
Paris, France
Principal Investigator: Laurence AMAR         
Sub-Investigator: Benoit VEDIE         
Assistance Publique Hopitaux de Paris, Cochin Recruiting
Paris, France
Principal Investigator: Jerome BERTHERAT         
Sub-Investigator: Beatrice PARFAIT         
Assistance Publique Hopitaux de Paris, Necker Recruiting
Paris, France
Principal Investigator: Chris OTTOLENGHI         
Sub-Investigator: Marie-Alexandra ALYANAKIAN         
Assistance Publique Hopitaux de Paris, Pitie Salpetriere Recruiting
Paris, France
Principal Investigator: Cecile GHANDER         
Sub-Investigator: Frederique TISSIER         
CHU Reims, Hopital Robert Debre Recruiting
Reims, France
Principal Investigator: Benedicte DECOUDIER         
Sub-Investigator: Marie-Danielle DIEBOLD         
CHU Rennes, Hopital Sud Recruiting
Rennes, France
Principal Investigator: Isabelle GUILHEM         
Sub-Investigator: Catherine MASSART         
CHU Strasbourg, Hopital de Hautepierre Recruiting
Strasbourg, France
Principal Investigator: Bernard GOICHOT         
Sub-Investigator: Marie-Pierre NEU-CHENARD         
CHU Toulouse, IUC Oncopole Recruiting
Toulouse, France
Principal Investigator: Philippe CARON         
Sub-Investigator: Anne BROUCHET         
CHU Tours, Hopital Bretonneau Recruiting
Tours, France
Principal Investigator: Peggy RENOULT-PIERRE         
Sub-Investigator: Caroline GADRAS         
Institut Gustave Roussy Recruiting
Villejuif, France
Principal Investigator: Eric BAUDIN         
Sub-Investigator: Abir AL-GHUZLAN         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Institut National de la Santé Et de la Recherche Médicale, France
National Cancer Institute, France
Investigators
Principal Investigator: Anne-Paule GIMENEZ-ROQUEPLO Assistance Publique Hopitaux de Paris-HEGP, Paris, France

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02672020     History of Changes
Other Study ID Numbers: NI14028
PRTK-14-079 ( Other Grant/Funding Number: Ministry of Health )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
pheochromocytoma
paraganglioma
adrenocortical carcinoma

Additional relevant MeSH terms:
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents