NIS CAROLIN

In this Non-interventional study (NIS) patients with platin-sensitive relapsed ovarian cancer (OC) will be included who are eligible for Niraparib treatment (treatment decision by physician independently before inclusion of the patients into the study). The Niraparib treatment will be according to SmPC. During the NIS study data will be collected at baseline, every 3 months during Niraparib treatment and every 6 months during up to 7 years of follow-up (long term survival) or patient’s death whatever comes first.

{ "short_title": "NIS CAROLIN", "data_mode": "900", "data_mode_number": "000002363", "official_title": "Characteristics related to Assessments of disease, patient and treatment \r\nassociated with long-term survival in ovarian cancer patients (CAROLIN)- \r\nIntergroup study NOGGO / A-AGO ", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "adjuvant", "therapielinie_value": "second", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studiensekretariat.gyn@ukdd.de", "general_contact_phone": "+49 351-4584202", "hauptpruefer_dd_name": "Prof. Dr. med. Pauline Wimberger", "description_laie_de": "Ziel dieser prospektiven, nicht-interventionellen Studie ist die Identifikation von Krankheits-, Patienten- und Behandlungsfaktoren, die mit einem Langzeit\u00fcberleben assoziiert sind. Die Gesamtstudiendauer betr\u00e4gt 9 Jahre (2 Jahre Rekrutierung und 7 Jahre Follow-up). An dieser Studie k\u00f6nnen einwilligungsf\u00e4hige, erwachsene Patien tinnen mit einem platinsensitiven Eierstock-, Eileiter- oder prim\u00e4ren Bauchfellkarzinom teilnehmen, die f\u00fcr eine Erhaltungstherapie mit Niraparib vorgesehen sind bzw. diese bereits bis zu max. 3 Monate erhalten.", "description_laie_en": "In this Non-interventional study (NIS) patients with platin-sensitive relapsed ovarian cancer (OC) will be included who are eligible for Niraparib treatment (treatment decision by physician independently before inclusion of the patients into the study). The Niraparib treatment will be according to SmPC. During the NIS study data will be collected at baseline, every 3 months during Niraparib treatment and every 6 months during up to 7 years of follow-up (long term survival) or patient\u2019s death whatever comes first.", "description_expert_de": "Ziel dieser prospektiven, nicht-interventionellen Studie ist die Identifikation von Krankheits-, Patienten- und Behandlungsfaktoren, die mit einem Langzeit\u00fcberleben assoziiert sind. Die Gesamtstudiendauer betr\u00e4gt 9 Jahre (2 Jahre Rekrutierung und 7 Jahre Follow-up). An dieser Studie k\u00f6nnen einwilligungsf\u00e4hige, erwachsene Patien tinnen mit einem platinsensitiven Eierstock-, Eileiter- oder prim\u00e4ren Bauchfellkarzinom teilnehmen, die f\u00fcr eine Erhaltungstherapie mit Niraparib vorgesehen sind bzw. diese bereits bis zu max. 3 Monate erhalten.", "description_expert_en": "In this Non-interventional study (NIS) patients with platin-sensitive relapsed ovarian cancer (OC) will be included who are eligible for Niraparib treatment (treatment decision by physician independently before inclusion of the patients into the study). The Niraparib treatment will be according to SmPC. During the NIS study data will be collected at baseline, every 3 months during Niraparib treatment and every 6 months during up to 7 years of follow-up (long term survival) or patient\u2019s death whatever comes first.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 15 }