Value of Information of Secondary dAta in ONCOGEnetics

Cancer Clinical Trial

— VISAGE-ONCO  

Official title:

Value of Information of Secondary dAta in ONCOGEnetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972409
• Other study ID #: 2019-A02303-54
• Status: Recruiting
• Start date: December 9, 2019
• Est. completion date: December 9, 2022

Study information

• Verified date: July 2021
• Source: Centre Georges Francois Leclerc
• Contact: Catherine LEJEUNE
• Phone: 0380393488
• Email: catherine.lejeune[@]u-bourgogne.fr
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Standard care patients for theranostic goal

• Histological or cytological evidence of a diagnosis of metastatic or locally advanced solid tumor

• Tumor material available and usable for the analyses required by the study

• Request for genetic analysis to be performed at the initiation of the 1st or 2nd line of treatment

• Normal biological parameters

• Life expectancy = 6 months

• Performance status = 1

• Social security affiliation

• Who have received information and agreed to participate

Patient from EX²TRICAN study

• Histological or cytological evidence of a diagnosis of metastatic or locally advanced solid tumor

• Having cancer before age 40

• Patient affiliated to social security

• Availability of a tumor sample if secondary functional studies are required

• Availability of the 2 parents when the trio approach is required

• Availability of affected relatives

• Who have received information and agreed to participate

Health professional

• To be oncologist or geneticist or genetic counselor and able to be inform, prescribe and transmit the results of secondary data

• Working at university hospital center of dijon or cancerology center Georges Francois Leclerc at Dijon

• Who have received information and agreed to participate

Exclusion Criteria:

Standard care patients for theranostic goal

• History of Human immunodeficiency virus infection

• History of Hepatitis B virus /Hepatitis C virus infection

• To be pregnant or likely to be or breastfeeding disorders psychiatric

Patient from EX²TRICAN study

• Minor index cases

• Disorders psychiatric

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Centre Georges Francois Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's experience through semi-structured interviews	Patients were asked during a semi-structured interview, to understand their feelings and experience ith regard to the possibility of having access to secondary findings	1 day (during the interview)