EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer (EX²TRICAN)
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| ClinicalTrials.gov Identifier: NCT04141462 |
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Recruitment Status :
Recruiting
First Posted : October 28, 2019
Last Update Posted : October 28, 2019
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Sponsor:
Centre Georges Francois Leclerc
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
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Brief Summary:
5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Genetic Predisposition | Genetic: blood sample | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 613 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer |
| Actual Study Start Date : | July 2, 2019 |
| Actual Primary Completion Date : | October 10, 2019 |
| Estimated Study Completion Date : | October 10, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Patients with a a constitutional genetic alteration
one genetic consultation and one blood test
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Genetic: blood sample
blood test |
Primary Outcome Measures :
- genetic mutations [ Time Frame: inclusion ]SHD-E analysis
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Index case:
- Major or minor patient
- Histological or cytological evidence of malignant tumor diagnosis
- Patient with cancer before age 40 (or before age 30 for breast cancer).
- Absence of anomaly found on the oncogenetic panel tested in the predisposition concerned
- Patient affiliated to a social security scheme
- Signature of Informed Consent EXTRICAN
- Availability of a tumor sample if needed secondary functional studies
- Availability of both parents when the trio approach will be necessary in the population 1 (or validation of the indication in CPR in case of non-availability of both parents)
- Availability of affected relatives in population 2 (or validation of the indication in SPC in case of non-availability of the related person)
Related:
- Major or minor patient
- Histological or cytological evidence of the diagnosis of malignant tumor if
- Patient affiliated to a social security scheme
- Signing informed consent EXTRICAN
Exclusion Criteria:
Index and related case:
- Refusal of the patient participation
- Psychiatric illness and / or condition of the patient compromising the understanding of the information or the realization of the study
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant woman
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): NCT04141462
Contacts
| Contact: Laurence FAIVRE, PH | 03 80 29 53 13 | laurence.faivre@cgfl.fr | |
| Contact: Emilie REDERSTORFF | 03 45 34 81 16 | erederstorff@cgfl.fr |
Locations
| France | |
| CHRU Jean Minjoz | Not yet recruiting |
| Besançon, France | |
| Contact: Marie-Agnès COLLONGE-RAME 03 81 21 81 87 macollongerame@chu-besancon.fr | |
| Centre Georges-François Leclerc | Recruiting |
| Dijon, France, 21000 | |
| Contact: Laurence FAIVRE, PH 03 80 29 53 13 laurence.faivre@cgfl.fr | |
| Contact: Emilie REDERSTORFF, PhD 03 45 34 81 16 erederstorff@cgfl.fr | |
| Principal Investigator: Laurence FAIVRE, PH | |
| Sub-Investigator: François GHIRINGHELLI, PU PH | |
| CHU de Dijon | Not yet recruiting |
| Dijon, France | |
| Contact: Laurence FAIVRE 03 80 29 53 13 laurence.faivre@cgfl.fr | |
| CHU de Reims | Not yet recruiting |
| Reims, France | |
| Contact: Monique MOZELLE 03 26 78 90 03 mmozelle@chu-reims.fr | |
| Polyclinique de Courlancy | Not yet recruiting |
| Reims, France | |
| Contact: Frederique CARRE-PIGEON 03 26 78 90 03 Fcarre-pigeon@groupe-courlancy.com | |
| CH de Troyes | Not yet recruiting |
| Troyes, France | |
| Contact: Monique MOZELLE 03 25 49 49 14 Monique.mozelle@ch-troyes.fr | |
Sponsors and Collaborators
Centre Georges Francois Leclerc
| Responsible Party: | Centre Georges Francois Leclerc |
| ClinicalTrials.gov Identifier: | NCT04141462 |
| Other Study ID Numbers: |
EX²TRICAN |
| First Posted: | October 28, 2019 Key Record Dates |
| Last Update Posted: | October 28, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Centre Georges Francois Leclerc:
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genetic mutations early sporadic or familial cancer gene panel exome analysis high-throughput exome sequencing |
Additional relevant MeSH terms:
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Disease Susceptibility Genetic Predisposition to Disease Disease Attributes Pathologic Processes |