Systematic genetic testing for personalised ovarian cancer therapy (SIGNPOsT)

ISRCTN ISRCTN16988857
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

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

Study information

Study designProspective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSystematIc 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 acronymSIGNPOsT
Study objectivesNull 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) studiedEpithelial ovarian cancer
InterventionParticipants 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 typeBehavioural
Primary outcome measurePsychological 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 measures1. 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 date05/05/2017
Completion date04/05/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants280
Key inclusion criteria1. Aged over 18 years
2. Histological diagnosis of high-grade non-mucinous epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Key exclusion criteria1. Women with non-epithelial ovarian cancer
2. Women with low grade or mucinous epithelial ovarian cancer
3. Unable to consent
Date of first enrolment08/05/2017
Date of final enrolment04/05/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

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

Sponsor information

Queen Mary University of London
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

ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Charity

Barts and The London Charity

No information available

Results and Publications

Intention to publish date04/05/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults 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 planThe 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.