Clinical trial · Observational
Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR
Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Retrospective Cohort
- description
- 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.
- interventionNames
- Other: Niraparib
- label
- Cohort 2: Prospective Cohort
- description
- 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.
- interventionNames
- Other: Niraparib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * Patients aged \<18 years old * Patients unable to give informed consent, complete questionnaires in English or comply with study procedures (if applicable).
References
Publications (0)
Data not yet available