Clinical trial · Observational
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain - A GEICO Study
- 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)
The study consists of a retrospective observational, multicenter study in which the fundamental exposure factor being investigated is a drug (rucaparib). A clinical database will be built including clinical data in three scenarios of rucaparib treatment: (1) platinum-sensitive BRCA-mutated patients after progression, (2) maintenance therapy in patients after a platinum-sensitive relapse in response, and (3) treatment therapy in BRCA-mutated patients who are currently platinum-resistant. The specific objectives of the study are: * To describe patient characteristics/medical history, safety, efficacy, and dosing of on-label treatment with rucaparib in real-world patients (real-world data). * To describe patient characteristics/medical history, safety, efficacy, and dosing of all patients treated with rucaparib (including patients with on-label treatment and others) in real-world patients (real-world data). * To show that data obtained in clinical trials could be reproduced in non-screened patients.
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 |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (20)
- measure
- Number of Participants With Relevant Co-morbidities
- timeFrame
- 0 months - Measurements were done at baseline
- description
- Patient characteristics and medical history Detected diseases include: arterial hypertension, diabetes melliutus, COPD, ischemic cardiomyopathy, cerebrovascular disease, obesity, etc. Measurements were done at baseline
- measure
- Other Previous Cancers?
- timeFrame
- 0 months - Measurements were done at baseline
- description
- Patient characteristics and medical history. Descriptive statistics: Other cancers present during trial including endometrial, breast , colorrectal, lung or other cancers Measurements were done at baseline
- measure
- Family History of Cancers?
- timeFrame
- 0 months - Measurements were done at baseline
- description
- Patient characteristics and medical history Family history of other cancers including ovarian, breast and others Measurements were done at baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent must be signed by all patients participating in the study who can be interviewed in the hospital (accessible, alive patients). Informed consent may not be required from unaccessible patients (dead, lost, etc.) according to ethics committee permissions and applicable law for retrospective studies in Spain. 2. Histological diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the context of rucaparib access program (RAP) in Spain. 3. Adult women (18 years or more at the time of diagnosis). Exclusion Criteria: 1\. Patients without medical record available (lost, empty or unretrievable clinical information).
References
Publications (0)
Data not yet available