Ovarian CancerMONITOR-UKNCT04295577
Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR
An observational study of Ovarian Cancer and Peritoneal Cancer, run by Royal Marsden NHS Foundation Trust at 15 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- How many people
- 388 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 3 Feb 2020to 24 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are/have/ will be receiving Niraparib as maintenance treatment
Who may be able to join
- 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).
Who cannot join
- Patients aged <18 years old
- Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United Kingdom15 sites
Royal United Hospitals Bath
Bath, BA1 3NG
Belfast Health & Social Care Trust
Belfast, BT9 7AB
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED
Addenbrookes Hospital
Cambridge, CB2 0QQ
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, CF14 2TL
Morecambe Bay NHS Trust
Lancaster
St James's University Hospital
Leeds, LS9 7TF
Barts Health NHS Trust
London, E1 1FR
Northampton General Hospital NHS Trust
Northampton, NN1 5BD
Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust
Northwood, HA6 2RN
Queen's Hospital
Romford, RM7 0AG
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 5YA
Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
Royal Cornwall Hospitals NHS Trust
Truro, TR1 3LJ
About this study
Official title: Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience
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.
Read the detailed description
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. These pathways will include patients who have been registered and not prescribed drug. In these cases, the reason for patients not receiving Niraparib will be recorded. Up to 16 centres will be involved in the study. Centres will be selected based on interest in or experience of prescribing Niraparib and geographical location in order to give a representative picture of the management of Niraparib in the UK.
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.
The collection of QoL data, using EQ-5D-5L and EORTC QoL-OV28, FACT-O questionnaires will be mandatory. For patients continuing on Niraparib, data will be collected retrospectively to the point they sign the consent form, and prospectively. Going forward QoL data will not be collected for these patients unless available as part of routine clinical care and baseline QoL is available.
The collection of data relating to adverse events will be mandatory. The scope of adverse events to be recorded includes AEs, SAEs, ADRs and AESIs - see section 5.3.1 for definitions of these events. Details in respect of AEs and SAEs, ADRs and AESIs will be recorded during routine clinic visits or via standard of care contact with the patient.
No additional visits will be required, no study medication will be administrated, and no additional procedures will be performed outside the local routine practice as part of the trial. Patients will be managed and followed up according to routine practice. Only data available in the patient's medical record will be collected. Patients consented to cohort 2 will be asked to complete validated QoL tools; EQ-5D-5L, FACT-O and EORTC QOL-OV28. Approximately 350 patients will be enrolled with an estimated 100 in the retrospective cohort and 250 in the prospective cohort.
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Being tested
- Niraparib
- Keywords
- Niraparib
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibOther
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].
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Niraparib | |
| 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. Receives: Other: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Proportion of patients with at least one grade ≥3 treatment emergent adverse events (TEAEs)
Measured: February 2020 - August 2022
Secondary outcomes (10)
Treatment history for patients on Niraparib maintenance treatment
This will be composed of previous treatment details including duration, delays/ dose modifications.
Measured: February 2020 - February 2024
Patient demographics for patients on Niraparib maintenance treatment
To describe the patient population of those on Niraparib.
Measured: February 2020 - February 2024
Medical history for patients on Niraparib maintenance treatment
To ascertain the rationale for patients receiving Niraparib maintenance therapy
Measured: February 2020 - February 2024
Routine clinical practice of Niraparib maintenance treatment
To detail clinical management of Niraparib maintenance therapy in a real-world pragmatic setting.
Measured: February 2020 - February 2024
Time to First Subsequent Therapy (TFST)
This will be defined as the date of the start of Niraparib to the start date of the first subsequent anticancer therapy. The treatment prescribed at TFST will also be recorded.
Measured: February 2020 - February 2024
Chemotherapy Free Interval (CFI)
This will be defined as the time from the last platinum-based chemotherapy dose until initiation of next anticancer therapy (excluding maintenance therapy).
Measured: February 2020 - February 2024
Objective Response Rate (ORR)
Where indicated for Niraparib treatment, only for patients with measurable disease on baseline imaging. This will be defined as complete or partial response as judged by the investigator.
Measured: February 2020 - February 2024
Progression Free Survival (PFS)
This will be defined as time from start of Niraparib treatment to progression or death from any cause. Patients without an event will be censored at day of last follow up. Progression will be assessed by the investigator according to routine practice
Measured: January 2022 - February 2024
Quality of life for patients on Niraparib maintenance treatment
Quality of life (QoL) at protocol-specified time points will be assessed.
Measured: February 2020 - February 2024
Adverse events for patients on Niraparib maintenance treatment
Number of Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Averse Events of Special lnterest (AESIs)
Measured: February 2020 - February 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start3 Feb 2020
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susana Banerjee, MBBS MA PhD FRCP, Study chair, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295577
- Sponsor's protocol ID
- CCR4939
- Acronym
- MONITOR-UK
- Status last verified
- May 2026
- First submitted
- 13 Jan 2020
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience
- ClinicalTrials.gov ID
- NCT04295577
- Acronym / sponsor ID
- MONITOR-UK / CCR4939
- Conditions
- Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
- Keywords
- Niraparib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. These pathways will include patients who have been registered and not prescribed drug. In these cases, the reason for patients not receiving Niraparib will be recorded. Up to 16 centres will be involved in the study. Centres will be selected based on interest in or experience of prescribing Niraparib and geographical location in order to give a representative picture of the management of Niraparib in the UK.
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.
The collection of QoL data, using EQ-5D-5L and EORTC QoL-OV28, FACT-O questionnaires will be mandatory. For patients continuing on Niraparib, data will be collected retrospectively to the point they sign the consent form, and prospectively. Going forward QoL data will not be collected for these patients unless available as part of routine clinical care and baseline QoL is available.
The collection of data relating to adverse events will be mandatory. The scope of adverse events to be recorded includes AEs, SAEs, ADRs and AESIs - see section 5.3.1 for definitions of these events. Details in respect of AEs and SAEs, ADRs and AESIs will be recorded during routine clinic visits or via standard of care contact with the patient.
No additional visits will be required, no study medication will be administrated, and no additional procedures will be performed outside the local routine practice as part of the trial. Patients will be managed and followed up according to routine practice. Only data available in the patient's medical record will be collected. Patients consented to cohort 2 will be asked to complete validated QoL tools; EQ-5D-5L, FACT-O and EORTC QOL-OV28. Approximately 350 patients will be enrolled with an estimated 100 in the retrospective cohort and 250 in the prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Retrospective Cohort | – | Other: NiraparibThis 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 | – | Other: NiraparibThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are/have/ will be receiving Niraparib as maintenance treatment
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (2 listed)
- Patients aged <18 years old
- Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibNiraparib - 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]. | Other | Cohort 1: Retrospective Cohort, Cohort 2: Prospective Cohort |
Primary outcome
Treatment Emergent Adverse Events
Time frame: February 2020 - August 2022
Proportion of patients with at least one grade ≥3 treatment emergent adverse events (TEAEs)
10 secondary outcomes
Treatment history for patients on Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Patient demographics for patients on Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Medical history for patients on Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Routine clinical practice of Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Time to First Subsequent Therapy (TFST)
Time frame: February 2020 - February 2024
Chemotherapy Free Interval (CFI)
Time frame: February 2020 - February 2024
Objective Response Rate (ORR)
Time frame: February 2020 - February 2024
Progression Free Survival (PFS)
Time frame: January 2022 - February 2024
Quality of life for patients on Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Adverse events for patients on Niraparib maintenance treatment
Time frame: February 2020 - February 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Banerjee, MBBS MA PhD FRCP study chair
Royal Marsden NHS Foundation Trust
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Peritoneal Cancer, run by Royal Marsden NHS Foundation Trust at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (time frame: February 2020 - August 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.