Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR
NCT ID: NCT04295577
Last Updated: 2022-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2020-02-03
2024-02-03
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
OTHER
Study Groups
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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.
Niraparib
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\[13\].
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.
Niraparib
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\[13\].
Interventions
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Niraparib
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
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Inclusion Criteria
* 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).
Exclusion Criteria
* Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).
18 Years
FEMALE
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Susana Banerjee, MBBS MA PhD FRCP
Role: STUDY_CHAIR
Royal Marsden NHS Foundation Trust
Locations
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Royal United Hospitals Bath
Bath, , United Kingdom
Belfast Health & Social Care Trust
Belfast, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, , United Kingdom
Morecambe Bay NHS Trust
Lancaster, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Northampton General Hospital NHS Trust
Northampton, , United Kingdom
Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust
Northwood, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Trial Coordinator
Role: primary
Other Identifiers
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CCR4939
Identifier Type: -
Identifier Source: org_study_id
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