Breast Cancer RiskPROTECT-CNCT07498829
Population Based Germline Testing for Early Detection and Prevention of Cancer
A study testing Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk in people with Breast Cancer Risk and Ovarian Cancer Risk, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and/or womb cancer. This is regardless of whether they or their families have had cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Risk, Ovarian Cancer Risk, Cancer Gene Mutation
- What is being tested?
- Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2025to Dec 2040
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women, trans men, and non-binary people with female reproductive organs
- ≥18 years at consent
Who cannot join
- Individuals who have previously undergone genetic testing for one or more of the following CSGs: BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BRIP1, MLH1, MSH2, MSH6
- One or more first- or second-degree relative with a PV in any of above CSGs
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Wolfson Institute of Population Health, Queen Mary University of London
London, EC1M 6BQ
Ranjit Manchanda, PhD, +44 8008620236, r.manchanda@qmul.ac.uk
Caitlin Fierheller, PhD, +44 8008620236, protectc.study@qmul.ac.uk
About this study
PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and/or womb cancer. This is regardless of whether they or their families have had cancer.
Breast, ovary, bowel, and womb cancers make up half of all cancers in women. Around 15-20% (15 to 20 in 100 cases) of ovary and 3-4% (3 to 4 in 100 cases) of breast, womb, and bowel cancers are linked to cancer genes and may be prevented. People with a genetic change that puts them at increased risk of any of these cancers have ways to help them manage their risk through the NHS. This may include screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.
Read more
Currently, genetic testing is only available on the NHS to people who meet certain criteria. For example, those who have had certain cancers, have a strong family history of cancer, or those with Jewish ancestry. But many people may not have a strong family history or meet NHS testing criteria. This means that this system of testing misses 50% to 80% of people (50 to 80 in 100 people) who have a genetic change. It is thought that only around 3 in 100 people overall who have a genetic change that increases their risk of cancer know about it. Given the effective screening and preventive options that are available, this represents a huge, missed opportunity to prevent cancers or find them earlier.
The PROTECT-C study aims to evaluate the option of offering genetic testing to everyone who may want it. This is regardless of whether they or their families have had cancer. We will offer genetic testing to 5000 people. People may take part if they:
- Are over the age of 18 years and
- Are a woman, trans man, or non-binary person with female reproductive organs (ovaries, fallopian tubes, and/or a uterus) and
- Have never had genetic testing for the cancer genes tested for in the study and
- Do not have first-degree family members (e.g.: parent, sibling, child) or second-degree family members (e.g.: aunt, uncle, niece, nephew, grandchild, grandparent, half-sibling) with genetic changes in the cancer genes tested for in the study
PROTECT-C is a completely digital study. The study team will give participants access to an app developed specifically for this study. They can download this app using a smartphone or tablet or access it on any internet browser using a computer or laptop. Before they can access the app, participants will need to complete a consent form. They will also be asked to fill in a short questionnaire about themselves and their health. The PROTECT-C app contains information to help participants decide if they would like to have genetic testing. If they decide to have genetic testing, they will complete a consent form for genetic testing on the app. The study team will send them a saliva based test kit in the post.
The study will look at how many people decide to have genetic testing and how many of them are found to have a genetic change. It will evaluate their experience with using the app and how this approach to genetic testing affects their quality-of-life, satisfaction, and mental well-being. This will give us a better understanding of how well the app works as a way of offering genetic testing to people. The study is interested to see how people found to be at increased risk decide to manage their risk. We will assess the uptake of screening and prevention options. Few participants will be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional. The study will also assess if this way of offering genetic testing to people is affordable for the NHS.
- Being tested
- Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk
- Keywords
- Population based genetic testing, BRCA, Lynch Syndrome, breast cancer risk, ovarian cancer risk
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer riskGenetic
Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk for all women (including trans-men, and non-binary individuals with female reproductive organs) over the age of 18 years independent of any family or personal history of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Genetic testing | Experimental | Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk prediction Receives: Genetic: Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathogenic variant (PV) prevalence for multiple moderate to high penetrance CSGs (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) in women from unselected population-based genetic testing compared with FH-based genetic testing
The primary outcome measure is the proportion of women with one or more CSGs who have undergone genetic testing and received a valid result.
PV prevalence will be estimated by the number of observed PVs divided by the total number of individuals tested. An overall rate and CSG specific rates will be calculated. Standard NHS criteria at time of the study (i.e. Amsterdam-2 Criteria for Lynch Syndrome and 10% BRCA probability threshold for HBOC) will be used to evaluate family history criteria for genetic testing. The proportion of PVs fulfilling NHS testing criteria (FH positive) will be estimated. 95% Confidence Intervals for these outcomes will be calculated as per methods specified in the SAP (statistical analysis plan).
Measured: 1 year after completing recruitment
Secondary outcomes (12)
Satisfaction and regret (Satisfaction)
Satisfaction is measured as the proportion of positive responses to the statement "I am satisfied with the decision I have made"
Measured: measured at acceptance, 21 days, 6 months and 12 months
Satisfaction and regret (Regret)
Regret is measured as the proportion who score 10 or less using the Decision Regret Scale questionnaire (scale 5-25 where 5 indicates completely dissatisfied and 25 indicates completely satisfied).
Measured: measured at acceptance, 21 days, 6 months and 12 months
Quality of life using EQ5D- 5L
Quality of Life is measured using the EORTC Questionnaire EQ5D- 5L. Mean score (range 0-1) with higher scores indicating higher quality of life.
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Cancer worry
- Cancer worry score is measured using the Cancer Worry Scale questionnaire (4-item Cancer Worry Scale questionnaire on a 4-point Likert scale). Mean Cancer Worry Scale score (range 4-16) and self-reported VAS score (range 0-100); with higher score indicates greater concern
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Risk perception
Risk perception is measured as the proportion responding as at "high or much higher" chance of cancer to the statement "compared with other people of your age, do you think your chances of getting cancer at some point in your life are…"
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Anxiety and depression
Anxiety is measured using the Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire- Anxiety score (7-item questionnaire on a 4-point Likert scale).
Depression is measured using the HADS depression questionnaire -(7-item questionnaire on a 4-point Likert scale).
Scores range from 0-21 with higher scores indicating higher levels of anxiety/depression.
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Distress
Distress is measured using the Impact of Events (IES) questionnaire (22-item IES questionnaire on a 5-point Likert scale). Mean score IES Intrusive scale (range 0-35) and IES Avoidance scale (range 0-38); where higher scores indicate greater distress.
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Impact
Impact is measured using the Multidimensional Impact of Cancer (MICRA) questionnaire. Mean score overall (range 0 -105) with separate scores for distress, positive experiences and uncertainty. MICRA distress scale (range 0-30), MICRA positive experiences scale (range 0-20) and MICRA uncertainty scale (range 0-45); where higher scores indicates higher impact.
Measured: Pre-genetic testing and at 21 days, 6 months and 12 months
Uptake of risk management options
Uptake of risk management options (for breast, ovarian, endometrial and bowel cancers) are measured using self-reported, clinical and/or registry data
- Breast: Proportion of CSG carriers who undergo of self-examination, mammography, MRI, risk reducing mastectomy, medical prevention
- Ovary: Proportion of CSG carriers who undergo surveillance, or surgical prevention (risk reducing salpingo-oophorectomy or risk reducing early salpingectomy)
- Endometrial: Proportion of CSG carriers who undergo risk reducing hysterectomy (with bilateral salpingo-oophorectomy in women with Lynch Syndrome); endometrial cancer surveillance
- Bowel: Proportion of CSG carriers who undergo FIT test, colonoscopy, take aspirin
- Proportion of CSG carriers who undergo pre-implantation genetic testing in individuals planning a family
Measured: collected annually over 8 years
Uptake of cascade testing
Uptake of cascade testing is measured as the total number of people who undergo cascade testing per family in an individual with a PV in a CSG at 2 years after the return of the last test result
Measured: 2 years post return of last result in those recruited
VUS carrier frequency
measured as the proportion of VUS carriers in women who have undergone testing at 6 months after return of the last test result
Measured: 6 months after return of the last test result
Cost-effectiveness of genetic testing
Is measured by incremental cost-effectiveness ratio (ICER) comparing population testing strategy with a family history based testing strategy. ICER per QALY is compared to the NICE willingness to pay threshold in the UK (£30,000/QALY). Incremental costs, incremental QALYs and number of cancers/deaths prevented will be calculated and one-way and probabilistic sensitivity analysis undertaken.
Measured: 12 months after return of last test result - initial analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start18 Dec 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RiskStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional cohort study offering genetic testing for moderate to high penetrance Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and a personalised breast and ovarian cancer risk prediction using a digital app and saliva based DNA testing.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Manchester, London School of Hygiene and Tropical Medicine, Institute of Cancer Research, United Kingdom, University of Leeds, Imperial College London, University College, London, VU University Medical Center (VUmc), St George's, University of London
- Responsible party
- Sponsor
- Investigators
- Ranjit Manchanda, PhD, Principal investigator, Wolfson Institute of Population Health, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498829
- Sponsor's protocol ID
- IRAS 328404
- Other IDs
- REC Reference 24/NW/0294
- Acronym
- PROTECT-C
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patient data may be shared after completion of study and publication of all results, on reasonable request and communication from the Chief Investigator - via email - r.manchanda@qmul.ac.uk
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Based Germline Testing for Early Detection and Prevention of Cancer
- ClinicalTrials.gov ID
- NCT07498829
- Acronym / sponsor ID
- PROTECT-C / IRAS 328404
- Keywords
- Population based genetic testing, BRCA, Lynch Syndrome, breast cancer risk, ovarian cancer risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Manchester, London School of Hygiene and Tropical Medicine, Institute of Cancer Research, United Kingdom, University of Leeds, Imperial College London, University College, London, VU University Medical Center (VUmc), St George's, University of London
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 27 Mar 2026 (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.
PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and/or womb cancer. This is regardless of whether they or their families have had cancer.
Breast, ovary, bowel, and womb cancers make up half of all cancers in women. Around 15-20% (15 to 20 in 100 cases) of ovary and 3-4% (3 to 4 in 100 cases) of breast, womb, and bowel cancers are linked to cancer genes and may be prevented. People with a genetic change that puts them at increased risk of any of these cancers have ways to help them manage their risk through the NHS. This may include screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.
Currently, genetic testing is only available on the NHS to people who meet certain criteria. For example, those who have had certain cancers, have a strong family history of cancer, or those with Jewish ancestry. But many people may not have a strong family history or meet NHS testing criteria. This means that this system of testing misses 50% to 80% of people (50 to 80 in 100 people) who have a genetic change. It is thought that only around 3 in 100 people overall who have a genetic change that increases their risk of cancer know about it. Given the effective screening and preventive options that are available, this represents a huge, missed opportunity to prevent cancers or find them earlier.
The PROTECT-C study aims to evaluate the option of offering genetic testing to everyone who may want it. This is regardless of whether they or their families have had cancer. We will offer genetic testing to 5000 people. People may take part if they:
- Are over the age of 18 years and
- Are a woman, trans man, or non-binary person with female reproductive organs (ovaries, fallopian tubes, and/or a uterus) and
- Have never had genetic testing for the cancer genes tested for in the study and
- Do not have first-degree family members (e.g.: parent, sibling, child) or second-degree family members (e.g.: aunt, uncle, niece, nephew, grandchild, grandparent, half-sibling) with genetic changes in the cancer genes tested for in the study
PROTECT-C is a completely digital study. The study team will give participants access to an app developed specifically for this study. They can download this app using a smartphone or tablet or access it on any internet browser using a computer or laptop. Before they can access the app, participants will need to complete a consent form. They will also be asked to fill in a short questionnaire about themselves and their health. The PROTECT-C app contains information to help participants decide if they would like to have genetic testing. If they decide to have genetic testing, they will complete a consent form for genetic testing on the app. The study team will send them a saliva based test kit in the post.
The study will look at how many people decide to have genetic testing and how many of them are found to have a genetic change. It will evaluate their experience with using the app and how this approach to genetic testing affects their quality-of-life, satisfaction, and mental well-being. This will give us a better understanding of how well the app works as a way of offering genetic testing to people. The study is interested to see how people found to be at increased risk decide to manage their risk. We will assess the uptake of screening and prevention options. Few participants will be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional. The study will also assess if this way of offering genetic testing to people is affordable for the NHS.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional cohort study offering genetic testing for moderate to high penetrance Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and a personalised breast and ovarian cancer risk prediction using a digital app and saliva based DNA testing.
| Arm | Type | Receives |
|---|---|---|
| Genetic testing | Experimental | Genetic: Genetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer riskGenetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk prediction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women, trans men, and non-binary people with female reproductive organs
- ≥18 years at consent
Key exclusion criteria (3 listed)
- Individuals who have previously undergone genetic testing for one or more of the following CSGs: BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BRIP1, MLH1, MSH2, MSH6
- One or more first- or second-degree relative with a PV in any of above CSGs
- Inability to provide 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 testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer riskGenetic testing for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk for all women (including trans-men, and non-binary individuals with female reproductive organs) over the age of 18 years independent of any family or personal history of cancer. | Genetic | Genetic testing |
Primary outcome
Pathogenic variant (PV) prevalence for multiple moderate to high penetrance CSGs (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) in women from unselected population-based genetic testing compared with FH-based genetic testing
Time frame: 1 year after completing recruitment
The primary outcome measure is the proportion of women with one or more CSGs who have undergone genetic testing and received a valid result. PV prevalence will be estimated by the number of observed PVs divided by the total number of individuals tested. An overall rate and CSG specific rates will be calculated. Standard NHS criteria at time of the study (i.e. Amsterdam-2 Criteria for Lynch Syndrome and 10% BRCA probability threshold for HBOC) will be used to evaluate family history criteria for genetic testing. The proportion of PVs fulfilling NHS testing criteria (FH positive) will be estimated. 95% Confidence Intervals for these outcomes will be calculated as per methods specified in the SAP (statistical analysis plan).
12 secondary outcomes
Satisfaction and regret (Satisfaction)
Time frame: measured at acceptance, 21 days, 6 months and 12 months
Satisfaction and regret (Regret)
Time frame: measured at acceptance, 21 days, 6 months and 12 months
Quality of life using EQ5D- 5L
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Cancer worry
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Risk perception
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Anxiety and depression
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Distress
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Psychosocial wellbeing - Impact
Time frame: Pre-genetic testing and at 21 days, 6 months and 12 months
Uptake of risk management options
Time frame: collected annually over 8 years
Uptake of cascade testing
Time frame: 2 years post return of last result in those recruited
VUS carrier frequency
Time frame: 6 months after return of the last test result
Cost-effectiveness of genetic testing
Time frame: 12 months after return of last test result - initial analysis
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 27 Mar 2026.
- PROTECT-C Web siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Patient data may be shared after completion of study and publication of all results, on reasonable request and communication from the Chief Investigator - via email - r.manchanda@qmul.ac.uk
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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.
Ranjit Manchanda, PhD principal investigator
Wolfson Institute of Population Health, Queen Mary University of London
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 for Cancer Susceptibility Genes (CSGs) (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) and personalised breast and ovarian cancer risk in people with Breast Cancer Risk and Ovarian Cancer Risk, run by Queen Mary University of London at 1 site in United Kingdom.
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 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 27 Mar 2026. 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 Kingdom. 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?
Contact Ranjit Manchanda, PhD (+44 8008620236, r.manchanda@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathogenic variant (PV) prevalence for multiple moderate to high penetrance CSGs (BRCA1, BRCA2, RAD51C, RAD51D, BRIP1, PALB2, MLH1, MSH2, MSH6) in women from unselected population-based genetic testing compared with FH-based genetic testing (time frame: 1 year after completing recruitment). 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 27 Mar 2026.