Value of Information of Secondary dAta in ONCOGEnetics — VISAGE-ONCO  

Cancer Clinical Trial

Official title: Value of Information of Secondary dAta in ONCOGEnetics

Status Recruiting

Clinical Trial Summary

VISAGE-ONCO study is a qualitative transversal study aiming to identify and describe processes and mechanisms that explain in cancerology the feelings and experience of patients and health professionals with regard to the possibility of having access to secondary findings generated by the use High-speed exome sequencing . Semi-structured interviews will be conducted with patients and health professionals to answer this aims from 2 situations.

The first situation is in the context of the standard practice for theranostic purposes, where somatic and constitutional analysis of the various genes involved in carcinogenesis is carried out systematically in parallel. Patients are informed that the analysis of these genes may reveal the existence of a genetic predisposition to another type of cancer than the one for which patients have consulted, with a risk for themselves or their relatives, which could modify their management. This targeted information on genetic predisposition genes to cancer is therefore provided as part of standard management for theranostic purposes, but without any detailed exploration of the reasons why patients wanted to be informed.

The second situation is in the framework exome analysis position in the strategy of genetic redisposition factors identification in early-onset cancer study (EX²TRICAN NCT04141462) where all the genes identified in human pathology are part of the analysis. Patients have the possibility of accessing a result concerning a gene that may or may not be linked to a hereditary cancer risk if patients have ticked off in the consent form the wish to be informed.

Therefore, two distinct questions arise:

• That of understanding the wish of patients to be given back actionable data which can be identified in a fortuitous way within the framework of standard management for theranostic purposes and in EX²TRICAN, by taking into account the fact that these data can constitute an opportunity for the patient in terms of management; but patients also constitute a risk of transmission for they relatives, and a psychological risk by the anxiety generated;

• The wish to have access - or not - to data which are not actively sought today within the framework of standard care for theranostic purposes and in EX²TRICAN (genetic alterations increasing the risk of cardiovascular or metabolic diseases), but which could be proposed in a systematic way in the future because of their actionable character.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cancer
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Neoplasm Metastasis

• NCT number: NCT04972409
• Study type: Observational
• Source: Centre Georges Francois Leclerc
• Contact: Catherine LEJEUNE
• Phone: 0380393488
• Email: catherine.lejeune@u-bourgogne.fr
• Status: Recruiting
• Start date: December 9, 2019
• Completion date: December 9, 2022