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NCT04972409: VISAGE-ONCO
Value of Information of Secondary dAta in ONCOGEnetics
trial in Cancer in 70 participants. Status unknown.
9 June 2022
Quick facts
| Lead sponsor | Centre Georges Francois Leclerc |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 70 |
| Start date | 9 December 2019 |
| Primary completion | 9 June 2022 |
| Estimated completion | 9 December 2022 |
| Sites | 1 location across France |
Conditions studied
- Cancer — all drugs for Cancer →
- Genetic Predisposition — all drugs for Genetic Predisposition →
- Secondary Fundings — all drugs for Secondary Fundings →
Sponsor
Centre Georges Francois Leclerc — full company profile →
Who can join
18 and older, any sex, with Cancer or Genetic Predisposition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04972409
- Europe PMC full search
- ASCO Meeting Library
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04972409 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Georges Francois Leclerc
- Last refreshed: 22 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04972409.
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