Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR
MONITOR-UK
1 other identifier
observational
388
1 country
15
Brief Summary
This is a multi-centre, observational (non-interventional) study, designed to follow patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are receiving Niraparib as maintenance treatment, according to the Niraparib access criteria (via TESARO patient access programme, EMA licence and NHS pending NICE assessment due 2018) including assessment of tolerability to Niraparib therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2020
CompletedStudy Start
First participant enrolled
February 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2026
CompletedMay 13, 2026
May 1, 2026
6.2 years
January 13, 2020
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Emergent Adverse Events
Proportion of patients with at least one grade ≥3 treatment emergent adverse events (TEAEs)
February 2020 - August 2022
Secondary Outcomes (10)
Treatment history for patients on Niraparib maintenance treatment
February 2020 - February 2024
Patient demographics for patients on Niraparib maintenance treatment
February 2020 - February 2024
Medical history for patients on Niraparib maintenance treatment
February 2020 - February 2024
Routine clinical practice of Niraparib maintenance treatment
February 2020 - February 2024
Time to First Subsequent Therapy (TFST)
February 2020 - February 2024
- +5 more secondary outcomes
Study Arms (2)
Cohort 1: Retrospective Cohort
This cohort will include: * Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib but in whom quality of life data are not available. * Patients who have previously commenced Niraparib prior to the MONITOR Study opening at the site but are now deceased but will be eligible for retrospective data collection without the need for informed consent. * Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site but have discontinued treatment. * Data in respect of AEs, SAEs, ADRs and AESIs will be recorded in Case Report Forms and be identified via the patient's medical records. There is no requirement to complete trial specific SAE reporting forms in this cohort.
Cohort 2: Prospective Cohort
This cohort will include: * Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib and in whom quality of life data is available. * Patients who are due to commence maintenance Niraparib treatment.
Interventions
Niraparib - Niraparib is an oral, highly selective PARP-1 and -2 inhibitor. However, it also inhibits other members of the PARP family, including PARP 3, -4, -10, 12, -14, and -15\[13\].
Eligibility Criteria
Patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are/have/ will be receiving Niraparib as maintenance treatment
You may qualify if:
- Female patient 18 years old or over
- Patients who are planned to receive Niraparib for advanced ovarian fallopian tube or primary peritoneal cancer,
- Patients who have previously commenced maintenance Niraparib prior to study opening at site
- Deceased patients who have previously been prescribed Niraparib
- Patients able to give written informed consent, complete questionnaires in English and comply with study procedures (if applicable).
You may not qualify if:
- Patients aged \<18 years old
- Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Royal United Hospitals Bath
Bath, BA1 3NG, United Kingdom
Belfast Health & Social Care Trust
Belfast, BT9 7AB, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
Addenbrookes Hospital
Cambridge, CB2 0QQ, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, CF14 2TL, United Kingdom
Morecambe Bay NHS Trust
Lancaster, United Kingdom
St James's University Hospital
Leeds, LS9 7TF, United Kingdom
Barts Health NHS Trust
London, E1 1FR, United Kingdom
Northampton General Hospital NHS Trust
Northampton, NN1 5BD, United Kingdom
Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust
Northwood, HA6 2RN, United Kingdom
Queen's Hospital
Romford, RM7 0AG, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 5YA, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susana Banerjee, MBBS MA PhD FRCP
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2020
First Posted
March 4, 2020
Study Start
February 3, 2020
Primary Completion
April 24, 2026
Study Completion
April 24, 2026
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share