Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8NCT04002986
Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
A study testing Genetic Testing in people with Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
- What is being tested?
- Genetic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2019to 24 May 2021
- Phase
- Interventional
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women participating in IRB:18-010601
- Aged 35 and over with a negative routine mammogram within 3 months.
- Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).
- Have an active email address for survey completion
Who cannot join
- Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
- Known genetic cancer syndrome with test results available for review in Mayo EMR
- Known breast cancer
- Unable to understand or sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.
- Conditions
- Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
- Being tested
- Genetic Testing
- Keywords
- increased risk of breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic TestingGenetic
A blood draw or saliva kit will be provided to collect subject cells
| Study group | Role | What they receive |
|---|---|---|
| Women at intermediate/high risk of breast cancer | Experimental | Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing Receives: Genetic: Genetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic mutations
Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Measured: One year
Study Participants
Number of subjects who decide to undergo genetic panel testing
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start20 Aug 2019
- Primary completion24 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niloy Jewel (Jewel) Samadder, Mayo Clinic
- Investigators
- N. Jewel Samadder, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002986
- Sponsor's protocol ID
- 19-004343
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2019
- Last updated
- 24 Jul 2023
- 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Genetic Assessment, Risk and Education in a Mammography Pilot
- ClinicalTrials.gov ID
- NCT04002986
- Acronym / sponsor ID
- 19-004343
- Conditions
- Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8
- Keywords
- increased risk of breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 1 Jul 2019 (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.
Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women at intermediate/high risk of breast cancer | Experimental | Genetic: Genetic TestingWomen age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women participating in IRB:18-010601
- Aged 35 and over with a negative routine mammogram within 3 months.
- Qualifies as intermediate or high-risk (>15% lifetime risk of breast cancer as defined by IBIS version 8).
- Have an active email address for survey completion
Key exclusion criteria (4 listed)
- Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
- Known genetic cancer syndrome with test results available for review in Mayo EMR
- Known breast cancer
- Unable to understand or sign informed consent
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 |
|---|---|---|
| Genetic TestingA blood draw or saliva kit will be provided to collect subject cells | Genetic | Women at intermediate/high risk of breast cancer |
Primary outcome
Genetic mutations
Time frame: One year
Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)
Study Participants
Time frame: One year
Number of subjects who decide to undergo genetic panel testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
N. Jewel Samadder, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic Testing in people with Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genetic mutations (time frame: One year). The study lists 2 primary outcomes in all. 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 24 Jul 2023.