Systematic genetic testing for personalised ovarian cancer therapy (SIGNPOsT)

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16988857

Enrollment

280

Registered

2017-06-29

Start date

2017-05-08

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial ovarian cancer Cancer Epithelial ovarian cancer

Interventions

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 BR

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Histological diagnosis of high-grade non-mucinous epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer

Exclusion criteria

Exclusion criteria: 1. Women with non-epithelial ovarian cancer 2. Women with low grade or mucinous epithelial ovarian cancer 3. Unable to consent

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026