GCaPPS: Genetic Cancer Prediction through Population Screening

ISRCTN	ISRCTN73338115
DOI	https://doi.org/10.1186/ISRCTN73338115
Protocol serial number	08/0141
Sponsor	University College London (UK)
Funder	Eve Appeal (UK)

Submission date: 15/07/2008
Registration date: 21/07/2008
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-testing-ashkenazi-jewish-people-for-cancer-gene-gcapps

Contact information

Prof Ian Jacobs
Scientific

Gynaecological Cancer Research Centre
EGA Institute for Womens Health
University College London
First Floor
Maple House
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Genetic Cancer Prediction through Population Screening
Study acronym	GCaPPS
Study objectives	1. Systematic population testing detects more mutations than testing on the basis of family history alone 2. There is no increase in psychological morbidity with systematic population testing compared to genetic testing based on family history
Ethics approval(s)	Great Ormond Street Hospital and Institute for Child Health Research Ethics Committee, 09/06/2008, ref: 08/H0713/44
Health condition(s) or problem(s) studied	Genetic testing for BRCA founder mutations
Intervention	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 germ-line cancer predisposition to the current approach based on family history. Interventions include the following: 1. Genetic counselling: All volunteers will receive pre-test education and counselling prior to decision making regarding testing. 2. Genetic testing: Genetic analysis for the 3 Jewish FM: 185 delAG, 5382 insC (in BRCA1) and 6174 delT (in BRCA2) will be performed on peripheral blood samples obtained in those individuals who consent to testing following counselling. All individuals in the systematic screening group and those individuals who have a positive family history of cancer in the family history group will undergo testing. 3. Questionnaires used include: 3.1. Baseline questionnaire (collected before counselling) 3.2. Post-counselling assessment questionnaire (after counselling, at decision making) 3.3. Exit questionnaire (for those declining testing after counselling) 3.4. Follow-up Questionnaire-1 (day 7 and 3 months after receiving test result) 3.5. Follow-up Questionnaire-2 (1 year after receiving test result) 3.6. Follow-up Questionnaire-3 (2 and 3 years after receiving test result)
Intervention type	Other
Primary outcome measure(s)	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 impact based on standard practise. 5.1. Quality adjusted life years (QALYs) 5.2. Cost-effectiveness, cost per case detected 6. The following will also be recorded: 6.1. Socio-demographics, identity scale and women's health by the baseline questionnaire 6.2. Knowledge assessment by the baseline questionnaire, post-counselling assessment questionnaire, and exit questionnaire (for those declining testing after counselling) 6.3. Perceived risk, assessed by the baseline questionnaire, post-counselling assessment questionnaire, Follow-up Questionnaires 1, 2 and 3 6.4. Fertility intention, assessed by the baseline questionnaire, Follow-up Questionnaire-2 6.5. Impact of result on fertility intention, assessed by the Follow-up Questionnaires 1 and 2 See Interventions for timepoints at which the questionnaires will be carried out.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/09/2016

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	10000
Total final enrolment	1034
Key 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)
Key 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
Date of first enrolment	01/09/2008
Date of final enrolment	01/09/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London

London
W1T 7DN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2016		Yes	No
Results article		10/11/2021	11/11/2021	Yes	No
Results article	Long term secondary lifestyle behavioural outcomes	04/07/2022	06/07/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
06/07/2022: Publication reference added.
11/11/2021: Publication reference added.
21/03/2016: Publication reference added.