Adrenal Gland NeoplasmsCOMETETACTICNCT02672020
Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card
A study testing omics identity card in people with Adrenal Gland Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 21 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Adrenal Gland Neoplasms
- What is being tested?
- omics identity card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 21 sitesFrance
- Study dates
- Nov 2015to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient operated on a tumor developed from the adrenal cortex or a pheochromocytoma or a paraganglioma
- Age≥15 years
- Signature of the informed consent
Who cannot join
- None
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
France21 sites
CHU-Angers
Angers
CHU Rouen-Hopital de Bois-Guillaume
Bois-Guillaume
CHU Bordeaux, Hopital du Haut Leveque
Bordeaux
CHU Brest, Hopital de la Cavale Blanche
Brest
HCL- Centre Hospitalier Lyon Est
Bron
CHU Clermont-Ferrand, Hopital Gabriel Montpied
Clermont-Ferrand
CHU Grenoble- Hopital Albert Michallon
Grenoble
Assistance Publique Hopitaux de Pais, Hopital de Bicetre
Le Kremlin-Bicêtre
CHU Limoges, Hopital du Cluzeau
Limoges
CHU Montpellier, Hopital Lapeyronie
Montpellier
CHU Nantes, Hopital Laënnec
Nantes
Assistance Publique Hopitaux de Paris -HEGP
Paris
Assistance Publique Hopitaux de Paris, Cochin
Paris
Assistance Publique Hopitaux de Paris, Necker
Paris
Assistance Publique Hopitaux de Paris, Pitie Salpetriere
Paris
CHU Reims, Hopital Robert Debre
Reims
CHU Rennes, Hopital Sud
Rennes
CHU Strasbourg, Hopital de Hautepierre
Strasbourg
CHU Toulouse, IUC Oncopole
Toulouse
CHU Tours, Hopital Bretonneau
Tours
Institut Gustave Roussy
Villejuif
About this study
Official title: The COMETE Network, Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card
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.
Read more
We hypothesize that the improvement of MPP and ACC diagnosis and of the therapeutic options proposed to affected patients will require,
- the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers);
- 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".
Read the 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.
- Conditions
- Adrenal Gland Neoplasms
- Being tested
- omics identity card
- Keywords
- pheochromocytoma, paraganglioma, adrenocortical carcinoma
- Medical subject headings
- Adrenal Gland Neoplasms, Pheochromocytoma, Paraganglioma, Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omics identity cardBiological
| Study group | Role | What they receive |
|---|---|---|
| patients with adrenal tumor | Experimental | Not described Receives: Biological: omics identity card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant status
Number of participants with evidence of metastases
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startNov 2015
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adrenal Gland NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Anne-Paule GIMENEZ-ROQUEPLO, Principal investigator, Assistance Publique Hopitaux de Paris-HEGP, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672020
- Sponsor's protocol ID
- NI14028
- Other IDs
- PRTK-14-079
- Acronym
- COMETETACTIC
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25625332Letouze 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.
PubMed 23707781Assie 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.
PubMed 24747642
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMETE Network, Towards an Easy-to-use Adrenal Cancer/Tumor Identity Card
- ClinicalTrials.gov ID
- NCT02672020
- Acronym / sponsor ID
- COMETETACTIC / NI14028
- Conditions
- Adrenal Gland Neoplasms
- Keywords
- pheochromocytoma, paraganglioma, adrenocortical carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, National Cancer Institute, France
- Study start
- Nov 2015
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
- the transfer to routine practice and the prospective validation of the novel diagnostic and predictive biomarkers issued from recent discoveries (genetics, genomics, histological biomarkers);
- 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".
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with adrenal tumor | Experimental | Biological: omics identity card |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient operated on a tumor developed from the adrenal cortex or a pheochromocytoma or a paraganglioma
- Age≥15 years
- Signature of the informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omics identity card | Biological | patients with adrenal tumor |
Primary outcome
Malignant status
Time frame: Up to 36 months
Number of participants with evidence of metastases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Background: PubMed 25625332Castro-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.
- Background: PubMed 23707781Letouze 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.
- Background: PubMed 24747642Assie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Paule GIMENEZ-ROQUEPLO principal investigator
Assistance Publique Hopitaux de Paris-HEGP, Paris, France
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omics identity card in people with Adrenal Gland Neoplasms, run by Assistance Publique - Hôpitaux de Paris at 21 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Malignant status (time frame: Up to 36 months). 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 NCT02672020, which also lists 3 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 24 Sep 2019.