Systematic genetic testing for personalised ovarian cancer therapy (SIGNPOsT)

ISRCTN	ISRCTN16988857
DOI	https://doi.org/10.1186/ISRCTN16988857
Protocol serial number	ReDA11776
Sponsor	Queen Mary University of London
Funder	Barts and The London Charity

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-genetic-testing-for-ovarian-cancer-signpost

Contact information

Dr Ranjit Manchanda
Scientific

Queen Mary University of London
Room 4 Basement
Old Anatomy Building
Charterhouse square
London
EC1M 6BQ
United Kingdom

ORCID ID	0000-0003-3381-5057
Phone	+44 20 7882 5555
Email	r.manchanda@qmul.ac.uk

Study information

Primary study design	Observational
Study design	Prospective cohort study
Secondary study design	Cohort study
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	04/05/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centres

St Bartholomew’s Hospital

West Smithfield
London
EC1a 7BE
United Kingdom

Royal London Hospital

Whitechapel Road
Whitechapel
London
E1 1BB
United Kingdom

Queens Hospital

Romvalley Way
Romford
RM70AG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.