EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer (EX²TRICAN)

• ClinicalTrials.gov Identifier: NCT04141462
• Recruitment Status: Recruiting
• First Posted: October 28, 2019
• Last Update Posted: October 28, 2019
• Sponsor: Centre Georges Francois Leclerc
• Information provided by (Responsible Party): Centre Georges Francois Leclerc

Tracking Information

• First Submitted Date: October 23, 2019
• First Posted Date: October 28, 2019
• Last Update Posted Date: October 28, 2019
• Actual Study Start Date: July 2, 2019
• Actual Primary Completion Date: October 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 24, 2019)

genetic mutations [ Time Frame: inclusion ]

SHD-E analysis

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer
• Official Title: EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer
• 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.
• Detailed Description: The main objective of this study is to evaluate the interest of the SHD-E approaches after a negative result of the analysis called " gene panel " tested in routine in order to identify a genetic factor of predisposition to the cancer.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Cancer
• Genetic Predisposition

Intervention

Genetic: blood sample

blood test

Study Arms

Experimental: Patients with a a constitutional genetic alteration

one genetic consultation and one blood test

Intervention: Genetic: blood sample

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 24, 2019): 613
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 10, 2024
• Actual Primary Completion Date: October 10, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Index case:

1. Major or minor patient
2. Histological or cytological evidence of malignant tumor diagnosis
3. Patient with cancer before age 40 (or before age 30 for breast cancer).
4. Absence of anomaly found on the oncogenetic panel tested in the predisposition concerned
5. Patient affiliated to a social security scheme
6. Signature of Informed Consent EXTRICAN
7. Availability of a tumor sample if needed secondary functional studies
8. 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)
9. Availability of affected relatives in population 2 (or validation of the indication in SPC in case of non-availability of the related person)

Related:

1. Major or minor patient
2. Histological or cytological evidence of the diagnosis of malignant tumor if
3. Patient affiliated to a social security scheme
4. Signing informed consent EXTRICAN

Exclusion Criteria:

Index and related case:

1. Refusal of the patient participation
2. Psychiatric illness and / or condition of the patient compromising the understanding of the information or the realization of the study
3. Patient under guardianship, curatorship or safeguard of justice
4. Pregnant woman

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04141462
• Other Study ID Numbers: EX²TRICAN
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Georges Francois Leclerc
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Georges Francois Leclerc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Georges Francois Leclerc
• Verification Date: October 2019