Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ranjit Manchanda
ORCID ID
http://orcid.org/0000-0003-3381-5057
Contact details
Queen Mary University of London
Room 4 Basement
Old Anatomy Building
Charterhouse square
London
EC1M 6BQ
United Kingdom
+44 20 7882 5555
r.manchanda@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ReDA11776
Study information
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
Acronym
SIGNPOsT
Study hypothesis
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
National Research Ethics Committee - London Riverside, 29/03/2017, ref: 17/LO/0405
Study design
Prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
05/05/2017
Overall trial end date
04/05/2026
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 18 years
2. Histological diagnosis of high-grade non-mucinous epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
280
Participant exclusion criteria
1. Women with non-epithelial ovarian cancer
2. Women with low grade or mucinous epithelial ovarian cancer
3. Unable to consent
Recruitment start date
08/05/2017
Recruitment end date
04/05/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Bartholomew’s Hospital
West Smithfield
London
EC1a 7BE
United Kingdom
Trial participating centre
Royal London Hospital
Whitechapel Road
Whitechapel
London
E1 1BB
United Kingdom
Trial participating centre
Queens Hospital
Romvalley Way
Romford
RM70AG
Funders
Funder type
Charity
Funder name
Barts and The London Charity
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement:
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
Intention to publish date
04/05/2026
Participant level data
Available on request
Basic results (scientific)
Publication list