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

NCT02672020 | Completed

• 2 other identifiers: NI14028PRTK-14-079
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 21

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. 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. 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".

Conditions

Adrenal Gland Neoplasms

Keywords

pheochromocytoma; paraganglioma; adrenocortical carcinoma

Outcome Measures

Primary Outcomes (1)

• Malignant status

  Number of participants with evidence of metastases

  Up to 36 months

Study Arms (1)

patients with adrenal tumor

EXPERIMENTAL

Biological: omics identity card

Interventions

omics identity card BIOLOGICAL

patients with adrenal tumor

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• National Cancer Institute, France: collaborator

Study Sites (21)

CHU-Angers

Angers, France

Location

CHU Rouen-Hopital de Bois-Guillaume

Bois-Guillaume, France

Location

CHU Bordeaux, Hopital du Haut Leveque

Bordeaux, France

Location

CHU Brest, Hopital de la Cavale Blanche

Brest, France

Location

HCL- Centre Hospitalier Lyon Est

Bron, France

Location

CHU Clermont-Ferrand, Hopital Gabriel Montpied

Clermont-Ferrand, France

Location

CHU Grenoble- Hopital Albert Michallon

Grenoble, France

Location

Assistance Publique Hopitaux de Pais, Hopital de Bicetre

Le Kremlin-Bicêtre, France

Location

CHU Limoges, Hopital du Cluzeau

Limoges, France

Location

CHU Montpellier, Hopital Lapeyronie

Montpellier, France

Location

CHU Nantes, Hopital Laënnec

Nantes, France

Location

Assistance Publique Hopitaux de Paris -HEGP

Paris, France

Location

Assistance Publique Hopitaux de Paris, Cochin

Paris, France

Location

Assistance Publique Hopitaux de Paris, Necker

Paris, France

Location

Assistance Publique Hopitaux de Paris, Pitie Salpetriere

Paris, France

Location

CHU Reims, Hopital Robert Debre

Reims, France

Location

CHU Rennes, Hopital Sud

Rennes, France

Location

CHU Strasbourg, Hopital de Hautepierre

Strasbourg, France

Location

CHU Toulouse, IUC Oncopole

Toulouse, France

Location

CHU Tours, Hopital Bretonneau

Tours, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (3)

• Castro-Vega LJ, Letouze E, Burnichon N, Buffet A, Disderot PH, Khalifa E, Loriot C, Elarouci N, Morin A, Menara M, Lepoutre-Lussey C, Badoual C, Sibony M, Dousset B, Libe R, Zinzindohoue F, Plouin PF, Bertherat J, Amar L, de Reynies A, Favier J, Gimenez-Roqueplo AP. Multi-omics analysis defines core genomic alterations in pheochromocytomas and paragangliomas. Nat Commun. 2015 Jan 27;6:6044. doi: 10.1038/ncomms7044.

  PMID: 25625332 BACKGROUND

• Letouze E, Martinelli C, Loriot C, Burnichon N, Abermil N, Ottolenghi C, Janin M, Menara M, Nguyen AT, Benit P, Buffet A, Marcaillou C, Bertherat J, Amar L, Rustin P, De Reynies A, Gimenez-Roqueplo AP, Favier J. SDH mutations establish a hypermethylator phenotype in paraganglioma. Cancer Cell. 2013 Jun 10;23(6):739-52. doi: 10.1016/j.ccr.2013.04.018. Epub 2013 May 23.

  PMID: 23707781 BACKGROUND

• Assie G, Letouze E, Fassnacht M, Jouinot A, Luscap W, Barreau O, Omeiri H, Rodriguez S, Perlemoine K, Rene-Corail F, Elarouci N, Sbiera S, Kroiss M, Allolio B, Waldmann J, Quinkler M, Mannelli M, Mantero F, Papathomas T, De Krijger R, Tabarin A, Kerlan V, Baudin E, Tissier F, Dousset B, Groussin L, Amar L, Clauser E, Bertagna X, Ragazzon B, Beuschlein F, Libe R, de Reynies A, Bertherat J. Integrated genomic characterization of adrenocortical carcinoma. Nat Genet. 2014 Jun;46(6):607-12. doi: 10.1038/ng.2953. Epub 2014 Apr 20.

  PMID: 24747642 BACKGROUND

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Pheochromocytoma; Paraganglioma; Adrenocortical Carcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Adrenal Cortex Neoplasms; Adrenal Cortex Diseases

Study Officials

• Anne-Paule GIMENEZ-ROQUEPLO

  Assistance Publique Hopitaux de Paris-HEGP, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: February 3, 2016
• Study Start: November 1, 2015
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: September 24, 2019

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)