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NCT Number: NCT04141462

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

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.

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Key information

Conditions

Cancer Disease Attributes Disease Susceptibility Genetic Predisposition Genetic Predisposition to Disease Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Genetic

blood test

Primary outcomes

  1. genetic mutations

    Time frame: inclusion

    SHD-E analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Emilie REDERSTORFF

CONTACT

[email protected]

03 45 34 81 16

Sophie NAMBOT, Dr

CONTACT

[email protected]

03 80 29 53 13

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: EX²TRICAN

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2019
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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