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GCaPPS: Genetic Cancer Prediction through Population Screening

Genetic Cancer Prediction through Population Screening

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN73338115
Enrollment
10000
Registered
2008-07-21
Start date
2008-09-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic testing for BRCA founder mutations Cancer Malignant neoplasm of breast

Interventions

10,000 volunteers will be recruited in total
this number includes a pilot phase of 1,000 volunteers in the first year. This is a randomised controlled trial comparing a systematic population based approach to genetic testing for

Sponsors

University College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This is a healthy volunteer trial for Ashkenazi Jewish men and women. Inclusion criteria include: 1. Individuals over 18 years 2. Ashkenazi Jewish ethnicity (based on self-reported history of 4 Ashkenazi Jewish grandparents)

Exclusion criteria

Exclusion criteria: 1. Known BRCA mutation in an individual 2. First degree relative (FDR) of an individual with known BRCA mutation 3. Individuals who have already undergone BRCA founder mutation (FM) testing

Design outcomes

Primary

MeasureTime frame
1. Number of founder mutations (FM) detected, assessed by the genetic test result 2. Acceptability 2.1. Perception, attitudes towards BRCA1/2 testing: benefits, risks, limitations; cultural/religious influences; interest and intention, assessed by the baseline questionnaire and post-counselling assessment questionnaire 2.2. Satisfaction with counselling: Genetic Counselling Satisfaction Scale (GCSS), assessed as part of post-counselling assessment questionnaire and exit questionnaire (for those declining testing after counselling) 2.3. Uptake of testing 2.4. Reasons for declining testing, assessed by the exit questionnaire (for those declining testing after counselling) 3. Psychological impact, assessed by the baseline questionnaire, Follow-up Questionnaires 1, 2 and 3. These included the following: 3.1. Hospital Anxiety and Depression Scale (HADS): General well being, depression and anxiety 3.2. Short Form 12 (SF12): Psychological Quality of life (QoL) tool 3.3. Health Anxiety Inventory (HAI) 3.4. Multidimensional Impact of Cancer Risk Assessment (MICRA). This measure is used in Follow-up Questionnaires 1, 2 and 3 to assess the impact of test result 4. Uptake of screening and preventive strategies. Behavioural outcomes assessed by the baseline questionnaire, Follow-up Questionnaires 2 and 3. They included the following assessments: 4.1. Lifestyle behaviours (diet, exercise, alcohol, vitamins, etc.) 4.2. Cancer screening behaviours 4.3. Prophylactic surgery and chemoprevention 5. Health economics will be assessed by the baseline questionnaire, Follow-up Questionnaires 1, 2 and 3. This will involve within trial analysis of the counselling, screening and preventive strategies undertaken as well as modelling to estimate resource imp

Secondary

MeasureTime frame
No secondary outcome measures

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 13, 2026