Condition category
Cancer
Date applied
07/06/2017
Date assigned
29/06/2017
Last edited
11/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

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 measures

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

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

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Director of Research Services & Business Development
Joint Research Management Office (JRMO)
QM Innovation Building
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Internal review.