CancerVISAGE-ONCONCT04972409
Value of Information of Secondary dAta in ONCOGEnetics
An observational study of Cancer and Genetic Predisposition, run by Centre Georges Francois Leclerc at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Genetic Predisposition, Secondary Fundings
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 9 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer who will undergo exomes analysis
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Georges Francois Leclerc
Dijon
Catherine LEJEUNE, 0380393488 ext. 33, catherine.lejeune@u-bourgogne.fr
Sandrine DABAKUYO, PHD, 0345348067, sdabakuyo@cgfl.fr
About this study
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.
Read more
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.
- Conditions
- Cancer, Genetic Predisposition, Secondary Fundings
- Medical subject headings
- Neoplasms, Genetic Predisposition to Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day (during the interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start9 Dec 2019
- Primary completion9 Jun 2022 (estimated)
- Study completion9 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François GHIRINGHELLI, PU-PH, Principal investigator, Centre Georges Francois Leclerc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972409
- Sponsor's protocol ID
- 2019-A02303-54
- Acronym
- VISAGE-ONCO
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Information of Secondary dAta in ONCOGEnetics
- ClinicalTrials.gov ID
- NCT04972409
- Acronym / sponsor ID
- VISAGE-ONCO / 2019-A02303-54
- Conditions
- Cancer, Genetic Predisposition, Secondary Fundings
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 9 Jun 2022 (estimated)
- Study completion
- 9 Dec 2022 (estimated)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer who will undergo exomes analysis
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient's experience through semi-structured interviews
Time frame: 1 day (during the interview)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François GHIRINGHELLI, PU-PH principal investigator
Centre Georges Francois Leclerc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Genetic Predisposition, run by Centre Georges Francois Leclerc at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine LEJEUNE (0380393488 ext. 33, catherine.lejeune@u-bourgogne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's experience through semi-structured interviews (time frame: 1 day (during the interview)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.