Systematic genetic testing for personalised ovarian cancer therapy (SIGNPOsT)
ISRCTN | ISRCTN16988857 |
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DOI | https://doi.org/10.1186/ISRCTN16988857 |
Secondary identifying numbers | ReDA11776 |
- Submission date
- 07/06/2017
- Registration date
- 29/06/2017
- Last edited
- 27/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Contact information
Dr Ranjit Manchanda
Scientific
Scientific
Queen Mary University of London
Room 4 Basement
Old Anatomy Building
Charterhouse square
London
EC1M 6BQ
United Kingdom
0000-0003-3381-5057 | |
Phone | +44 20 7882 5555 |
r.manchanda@qmul.ac.uk |
Study information
Study design | Prospective cohort study |
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Primary study design | Observational |
Secondary study design | Cohort study |
Study setting(s) | Hospital |
Study type | Other |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | SystematIc GeNetic testing for Personalised Ovarian cancer Therapy: A prospective cohort study investigating the impact of systematic germline panel and concomitant somatic testing in epithelial ovarian cancer on psychological health and quality of life |
Study acronym | SIGNPOsT |
Study objectives | Null hypothesis: There is no difference in psychological health between mutation carriers detected on panel-based genetic testing and concomitant somatic testing (of high grade non-mucinous epithelial ovarian cancer) compared to non-carriers. |
Ethics approval(s) | National Research Ethics Committee - London Riverside, 29/03/2017, ref: 17/LO/0405 |
Health condition(s) or problem(s) studied | Epithelial ovarian cancer |
Intervention | Participants attend a baseline visit where they undergo systematic genetic germline panel testing for BRCA1, BRCA2, RADL51C, RAD51D, BRIP1 gene mutations and concomitant somatic genetic testing for BRCA1 and BRCA2. They also have demographic data, family history and clinical outcomes collected. Participants are asked to fill out surveys about their anxiety, quality of life, and counselling satisfaction scale. Participants who decline the genetic test complete a survey called "reasons for declining genetic test". This visit takes around 55-60 minutes. After the results of the genetic testing is complete, participants then repeat the anxiety and quality of life surveys as well as have a psychological health test using the Multi-dimensional impact of Cancer Risks Assessment (MICRA) scale. This visit takes around 30 minutes. Six months after the test, participants again repeat the anxiety and quality of life surveys as well as have a psychological health test using the Multi-dimensional impact of Cancer Risks Assessment (MICRA) scale. This visits takes around 30 minutes. Participants then are asked to attend annual visits where they are surveyed for their patient satisfaction and if they regret their decisions. Participants again repeat the anxiety and quality of life tests. Only at the first annual visit since the genetic testings, participants again complete the MICRA test to have their psychological health assessed. The total follow up period is five years. |
Intervention type | Behavioural |
Primary outcome measure | Psychological health following test result is assessed by MICRA Multi-dimensional impact of Cancer Risk Assessment (MICRA) scale at 7-days post-result, 6-months and 12 months. |
Secondary outcome measures | 1. Patient reported quality of life is assessed by EORTC QLQ C-30, OV28, EN-24, and EQ5D-5L questionnaires at baseline, post-result, 6-months, 12 months and annually 2. Anxiety and depression are assessed using the Hospital anxiety, depression scale (HADS) at baseline, post-result, 6-months, 12 months and annually 3. Cost effectiveness is reported using the Incremental cost effectiveness ratio per quality adjusted life years (ICER/QALY) at the end of the study 4. Germline and somatic BRCA1, BRCA2 detection rate is measured as the number of carriers/number of cases at the end of the study 5. Uptake is measured as the proportion of eligible EOC patients who accepted the offer of genetic testing at baseline 6. Patient satisfaction is assessed by the adapted genetic counselling satisfaction scale– measured post recruitment. A decision regret scale is used at 12 months. 7. PARP Inhibitor uptake is assessed by proportion of participants commenced on PARP inhibitors and reported at the end of the study |
Overall study start date | 05/05/2017 |
Completion date | 04/05/2026 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 280 |
Key inclusion criteria | 1. Aged over 18 years 2. Histological diagnosis of high-grade non-mucinous epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer |
Key exclusion criteria | 1. Women with non-epithelial ovarian cancer 2. Women with low grade or mucinous epithelial ovarian cancer 3. Unable to consent |
Date of first enrolment | 08/05/2017 |
Date of final enrolment | 04/05/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St Bartholomew’s Hospital
West Smithfield
London
EC1a 7BE
United Kingdom
London
EC1a 7BE
United Kingdom
Royal London Hospital
Whitechapel Road
Whitechapel
London
E1 1BB
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Queens Hospital
Romvalley Way
Romford
RM70AG
United Kingdom
Romford
RM70AG
United Kingdom
Sponsor information
Queen Mary University of London
University/education
University/education
Director of Research Services & Business Development
Joint Research Management Office (JRMO)
QM Innovation Building, 5 Walden Street
London
E1 2EF
England
United Kingdom
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Barts and The London Charity
No information available
Results and Publications
Intention to publish date | 04/05/2026 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | Results of the study will be presented at scientific meetings and conferences and published in scientific journals. They will also be distributed through supporting charities, patient groups and the Barts Cancer Institute, QMUL web site. |
IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from r.manchanda@qmul.ac.uk after publication of all results |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No | ||
Other publications | Cohort study set within the recruitment to SIGNPOST | 26/09/2023 | 27/09/2023 | Yes | No |
Editorial Notes
27/09/2023: Publication reference added.
14/05/2018: Cancer Research UK lay summary link added to plain English summary field
16/01/2018: Internal review.
16/10/2017: Internal review.