All Types of Metastatic Solid MalignancyINFOGENENCT06550687
Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis.
A study testing Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis in people with All Types of Metastatic Solid Malignancy and 1st-line Treatment, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Types of Metastatic Solid Malignancy, 1st-line Treatment, Exome Analysis
- What is being tested?
- Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 19 Sep 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient identified for inclusion in the EXOMA 2 study (exome analysis request)
- Available to receive different types of information
- Fluent in French
- No prior oncogenetic consultation
- Having been informed of the objectives of the study and having given written non-objection to participate in the INFOGene study
- Authorizing audio recording of consultations and interviews
Who cannot join
- Patient who refused to participate in the EXOMA2 study (for phase 3 patients only)
- Has a psychiatric, cognitive or neurological disorder that makes participation impossible
- Working in the field of genetics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Georges-François Leclerc
Dijon, 21000
Sophie Nambot, Dr, 0380295313 ext. +33, snambot@cgfl.fr
Sophie Parnalland, 0345348077 ext. +33, sparnalland@cgfl.fr
- Recruiting
CHU François Mitterand
Dijon, 21000
Sophie Nambot, Dr, 0380295313 ext. +33, sophie.nambot@chu-dijon.fr
About this study
Official title: Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis. Qualitative Observational and Interventional Cross-sectional Study
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
Read the detailed description
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
Phase 1 will aim to observe and analyze interpersonal communication between physicians prescribing theranostic exome analysis and cancer patients. It will be based on:
1/ ethnographic exploratory observations of 10 consultations during which the doctor will suggest that the patient undergo theranostic exome analysis, and 2/ semi-directed interviews with 10 new patients who have previously seen the doctor.
The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
- Step 1a : - construction of a consultation observation grid (based on existing literature) / - identification and inclusion of patients and physicians observed
- Step 1b : Observation of 10 consultations with a varied panel of prescribing physicians, taking into account taking into account gender, age, specialty and a heterogeneous sample of patients in socio-demographic and clinical terms
- Step 1c : semi-structured interview within 10 days of the consultation with consultation with 10 other patients by an SHS researcher to assess the degree of of the information provided by the doctor and whether it can be used to respond to the patient's needs.
- Step 1d : thematic content analysis
Phase 2 will consist in revisiting existing information supp orts (genetic counselor's explanatory note and and video). These materials will serve as a basis for work, and can be adapted according to the needs of the client.
Phase 3 will aim to evaluate patients' preferences with respect to 3 information modalities concerning a theranostic exome analysis.
- Step 3a: medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information reworked by the in phase 2
- Step 3b : semi-structured interview within 10 days with researcher with 30 of the 60 patients.
- Step 3c : 60 patients divided into 3 groups of 20 stratified by age, gender and cancer site. and cancer location, including 10 seen in interview:
- one group will receive information based solely on the video previously previously
- one group will receive information during a consultation
- one group will receive information first via the video and then during a consultation
- Step 3d : A new semi-structured interview with the 60 patients. These interviews will be carried out within 2 weeks of the information phase, in order to limit memory bias but also to allow time for the patients to express themselves.
- Conditions
- All Types of Metastatic Solid Malignancy, 1st-line Treatment, Exome Analysis, Active File EXOMA2 Study
- Being tested
- Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysisOther
Phase 1: Observation of doctor-patient consultations Phase 2: Adaptation of information tools Phase 3: Assessment of understanding of information tools
| Study group | Role | What they receive |
|---|---|---|
| Phase 1:Observe communication between physicians and cancer patients | Other | * Observation of the 10 consultations : To ensure heterogeneous sampling, a varied panel of prescribing physicians will be selected, taking into account gender, age and specialty (oncologist versus organ specialist).
* Conduct a semi-structured interview within 10 days of the consultation with 10 new patients who have been prescribed a theranostic exome analysis by a researcher
* Thematic content analysis of 10 consultation observations by SHS researchers and 10 semi-structured interviews which will enable us to assess the degree of understanding of the information provided by the doctor, and whether it answers the patient's questions. Receives: Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis |
| Phase 2 : Revisit existing information media (GGC information note and video). | No intervention | These materials will serve as a basis for our work, and may be adapted according to the results of phase 1 of our study. We will seek the advice of a partner patient, who will himself have benefited from a genetic analysis in the context of cancer, and who will be made aware of clinical research. |
| Phase 3:Assess patients' preferences with regard to 3 information modalities | Other | * A medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information, together with the explanatory note (INFOGene study)
* Within 10 days, a semi-structured interview with 30 of the 60 patients. These 30 patients will be selected to ensure maximum socio-demographic and clinical (cancer location) heterogeneity.
* Division of the 60 patients into 3 groups of 20 stratified according to age, gender and cancer location, including 10 previously interviewed (one group will receive the information based solely on the video worked previously, one group will receive the information during a consultation, one group will receive the information first via the video and then during a consultation).
* The researcher conducts a new semi-structured interview with the 60 patients. They will provide an insight into patients' experience of the information they receive (content, form, timing). Receives: Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concepts of communication and preferences.
The various interviews (phases 1 and 3) will provide an insight into patients' level of health literacy, which may explain the ease or difficulty of exchanges with the doctor (phase 1), as well as patients' preferences for one type of information over another (phase 3).
Measured: Through study completion, an average of 21 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start19 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Types of Metastatic Solid MalignancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550687
- Sponsor's protocol ID
- 2024-A00091-46
- Acronym
- INFOGENE
- Status last verified
- Feb 2025
- First submitted
- 6 Aug 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cancer Patients' Preferences for Genetic Information Modalities Preceding Theranostic Exome Analysis. Qualitative Observational and Interventional Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06550687
- Acronym / sponsor ID
- INFOGENE / 2024-A00091-46
- Conditions
- All Types of Metastatic Solid Malignancy, 1st-line Treatment, Exome Analysis, Active File EXOMA2 Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Aug 2024 (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.
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
Detailed description
Currently, the EXOMA2 study (NCT04614480) offers earlier and more comprehensive exome analysis in the management of cancer patients than EXOMA. Based on the active EXOMA2 patient file, the INFOGene study offers the opportunity to study patient-physician communication, to assess patient preferences with regard to different information modalities concerning theranostic exome analysis, and to reflect on information modalities to ensure optimal patient comprehension of the information provided.
The qualitative cross-sectional study includes a dual observational and interventional component involving cancer patients. The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
Phase 1 will aim to observe and analyze interpersonal communication between physicians prescribing theranostic exome analysis and cancer patients. It will be based on:
1/ ethnographic exploratory observations of 10 consultations during which the doctor will suggest that the patient undergo theranostic exome analysis, and 2/ semi-directed interviews with 10 new patients who have previously seen the doctor.
The patients will come from the EXOMA 2 active file at Dijon University Hospital and the CGFL.
- Step 1a : - construction of a consultation observation grid (based on existing literature) / - identification and inclusion of patients and physicians observed
- Step 1b : Observation of 10 consultations with a varied panel of prescribing physicians, taking into account taking into account gender, age, specialty and a heterogeneous sample of patients in socio-demographic and clinical terms
- Step 1c : semi-structured interview within 10 days of the consultation with consultation with 10 other patients by an SHS researcher to assess the degree of of the information provided by the doctor and whether it can be used to respond to the patient's needs.
- Step 1d : thematic content analysis
Phase 2 will consist in revisiting existing information supp orts (genetic counselor's explanatory note and and video). These materials will serve as a basis for work, and can be adapted according to the needs of the client.
Phase 3 will aim to evaluate patients' preferences with respect to 3 information modalities concerning a theranostic exome analysis.
- Step 3a: medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information reworked by the in phase 2
- Step 3b : semi-structured interview within 10 days with researcher with 30 of the 60 patients.
- Step 3c : 60 patients divided into 3 groups of 20 stratified by age, gender and cancer site. and cancer location, including 10 seen in interview:
- one group will receive information based solely on the video previously previously
- one group will receive information during a consultation
- one group will receive information first via the video and then during a consultation
- Step 3d : A new semi-structured interview with the 60 patients. These interviews will be carried out within 2 weeks of the information phase, in order to limit memory bias but also to allow time for the patients to express themselves.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1:Observe communication between physicians and cancer patients | Other | Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis* Observation of the 10 consultations : To ensure heterogeneous sampling, a varied panel of prescribing physicians will be selected, taking into account gender, age and specialty (oncologist versus organ specialist). * Conduct a semi-structured interview within 10 days of the consultation with 10 new patients who have been prescribed a theranostic exome analysis by a researcher * Thematic content analysis of 10 consultation observations by SHS researchers and 10 semi-structured interviews which will enable us to assess the degree of understanding of the information provided by the doctor, and whether it answers the patient's questions. |
| Phase 2 : Revisit existing information media (GGC information note and video). | No intervention | –These materials will serve as a basis for our work, and may be adapted according to the results of phase 1 of our study. We will seek the advice of a partner patient, who will himself have benefited from a genetic analysis in the context of cancer, and who will be made aware of clinical research. |
| Phase 3:Assess patients' preferences with regard to 3 information modalities | Other | Other: Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis* A medical consultation, during which the doctor will provide each of the 60 patients with the standard form of information, together with the explanatory note (INFOGene study) * Within 10 days, a semi-structured interview with 30 of the 60 patients. These 30 patients will be selected to ensure maximum socio-demographic and clinical (cancer location) heterogeneity. * Division of the 60 patients into 3 groups of 20 stratified according to age, gender and cancer location, including 10 previously interviewed (one group will receive the information based solely on the video worked previously, one group will receive the information during a consultation, one group will receive the information first via the video and then during a consultation). * The researcher conducts a new semi-structured interview with the 60 patients. They will provide an insight into patients' experience of the information they receive (content, form, timing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient identified for inclusion in the EXOMA 2 study (exome analysis request)
- Available to receive different types of information
- Fluent in French
- No prior oncogenetic consultation
- Having been informed of the objectives of the study and having given written non-objection to participate in the INFOGene study
Key exclusion criteria (3 listed)
- Patient who refused to participate in the EXOMA2 study (for phase 3 patients only)
- Has a psychiatric, cognitive or neurological disorder that makes participation impossible
- Working in the field of genetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysisPhase 1: Observation of doctor-patient consultations Phase 2: Adaptation of information tools Phase 3: Assessment of understanding of information tools | Other | Phase 1:Observe communication between physicians and cancer patients, Phase 3:Assess patients' preferences with regard to 3 information modalities |
Primary outcome
Concepts of communication and preferences.
Time frame: Through study completion, an average of 21 months.
The various interviews (phases 1 and 3) will provide an insight into patients' level of health literacy, which may explain the ease or difficulty of exchanges with the doctor (phase 1), as well as patients' preferences for one type of information over another (phase 3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer patients' preferences regarding genetic information modalities prior to theranostic exome analysis in people with All Types of Metastatic Solid Malignancy and 1st-line Treatment, run by Centre Georges Francois Leclerc at 2 sites 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concepts of communication and preferences. (time frame: Through study completion, an average of 21 months.). 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 18 Feb 2025.