Condition category
Cancer
Date applied
15/07/2008
Date assigned
21/07/2008
Last edited
21/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Ian Jacobs

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

08/0141

Study information

Scientific title

Genetic Cancer Prediction through Population Screening

Acronym

GCaPPS

Study hypothesis

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

Great Ormond Street Hospital and Institute for Child Health Research Ethics Committee, 09/06/2008, ref: 08/H0713/44

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Patient information can be found at: http://www.instituteforwomenshealth.ucl.ac.uk/gcapps/layversion.htm

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/09/2008

Overall trial end date

01/09/2016

Reason abandoned

Eligibility

Participant 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)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
W1T 7DN
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o Dr Oke Avwenagha
Research Governance Co-ordinator
Joint UCLH/UCL Biomedical Research Unit
Rosenheim Wing
Ground Floor
25 Grafton Way
London
WC1E 5DB
United Kingdom
+44 (0)20 7380 9928
avwenagha@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk

Funders

Funder type

Charity

Funder name

Eve Appeal (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26993268

Publication citations

Additional files

Editorial Notes

21/03/2016: Publication reference added.