BreastcancerRIVIERANCT02997384
Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
An observational study of Breastcancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastcancer
- What is being tested?
- Information
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Jun 2018
- 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 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women 40 to 74 years seen in consultation by their attending physician, gynecologist or radiologist
Who may be able to join
- Woman from 40 to 74 years old
- Understanding the French language
Who cannot join
- Women will not be eligible for study if they are in any of the following situations:
- Cancer active or in the course of treatment type surgery, chemotherapy, or radiotherapy, whether breast or other organ
- Recent diagnosis <1 year of suspicious or cancerous lesions
- Psychiatric pathology not compatible with the study
- Poor understanding of the French language
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.
- Conditions
- Breastcancer
- Being tested
- Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
information of women about their risk of breast cancer and the screening methods recommended for them
| Study group | Role | What they receive |
|---|---|---|
| General practitioner | Not described Receives: Other: Information | |
| gynecologist | Not described Receives: Other: Information | |
| radiologist | Not described Receives: Other: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997384
- Sponsor's protocol ID
- 2016-A01082-49
- Other IDs
- 2016/2422
- Acronym
- RIVIERA
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
- ClinicalTrials.gov ID
- NCT02997384
- Acronym / sponsor ID
- RIVIERA / 2016-A01082-49
- Conditions
- Breastcancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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.
This study aims to evaluate the feasibility (acceptability) of a consultation dedicated to informing women about their risk of breast cancer and the screening methods recommended for them according to the recommendations in force during a routine consultation at a general practitioner, a gynecologist or a radiologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General practitioner | – | Other: Information |
| gynecologist | – | Other: Information |
| radiologist | – | Other: Information |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women 40 to 74 years seen in consultation by their attending physician, gynecologist or radiologist
Key inclusion criteria (2 listed)
- Woman from 40 to 74 years old
- Understanding the French language
Key exclusion criteria (5 listed)
- Cancer active or in the course of treatment type surgery, chemotherapy, or radiotherapy, whether breast or other organ
- Recent diagnosis <1 year of suspicious or cancerous lesions
- Psychiatric pathology not compatible with the study
- Poor understanding of the French language
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 |
|---|---|---|
| Informationinformation of women about their risk of breast cancer and the screening methods recommended for them | Other | General practitioner, gynecologist, radiologist |
Primary outcome
Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Breastcancer, run by Gustave Roussy, Cancer Campus, Grand Paris 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 2 inclusion and 5 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 20 Dec 2016. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women who agreed to measure their risk with personalized surveillance and screening recommendations during the consultation (time frame: up to 1 year). 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 20 Dec 2016.