SCOUT-1

This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: - outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, - patient's follow-up (FU) during and after MTX therapy, - patient-reported outcomes (PROs), experiences and needs, - physician's experience, - BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, - patient selection for different 1L systemic treatment approaches, - use and safety of drugs, - treatment sequence in case of recurrence

{ "short_title": "SCOUT-1", "data_mode": "900", "data_mode_number": "000002180", "official_title": "Prospective Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcome Data in Ovarian Cancer Patients Eligible for First-line Platinum-based Chemotherapy and Intended for BRCA/HRD Testing", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": "NCT04830709", "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": "Diese prospektive nicht-interventionelle Studie soll neue Daten und Erkenntnisse zur Erstlinienbehandlung (1L) des neu diagnostizierten fortgeschrittenen hochgradigen epithelialen Ovarialkarzinoms (OC) in Deutschland generieren, die f\u00fcr Patienten, \u00c4rzte und Kostentr\u00e4ger relevant sind. Sie wird den Einfluss der 1L-Erhaltungstherapie (MTX) mit dem Poly-ADP-Ribose-Polymerase-Inhibitor (PARPi) auf den medizinischen Alltag in Deutschland erfassen, insbesondere auf: - Ergebnis der dreistufigen 1L-Behandlungsphase (einschlie\u00dflich Operation, Chemotherapie (CTX) und MTX) einschlie\u00dflich des Heilungspotenzials von Patienten mit prim\u00e4r fortgeschrittenem OC, - Patientennachsorge (FU) w\u00e4hrend und nach der MTX-Therapie, - patientenberichtete Ergebnisse (PROs), Erfahrungen und Bed\u00fcrfnisse, - Erfahrung des Arztes, - BRCA/HRD- und genomisches Narbentestverhalten bei Diagnose/w\u00e4hrend der 1L-Therapie, - Patientenauswahl f\u00fcr verschiedene systemische 1L-Behandlungsans\u00e4tze, - Einsatz und Sicherheit von Medikamenten, - Behandlungssequenz im Rezidivfall", "description_laie_en": "This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: - outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, - patient's follow-up (FU) during and after MTX therapy, - patient-reported outcomes (PROs), experiences and needs, - physician's experience, - BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, - patient selection for different 1L systemic treatment approaches, - use and safety of drugs, - treatment sequence in case of recurrence", "description_expert_de": "Diese prospektive nicht-interventionelle Studie soll neue Daten und Erkenntnisse zur Erstlinienbehandlung (1L) des neu diagnostizierten fortgeschrittenen hochgradigen epithelialen Ovarialkarzinoms (OC) in Deutschland generieren, die f\u00fcr Patienten, \u00c4rzte und Kostentr\u00e4ger relevant sind. Sie wird den Einfluss der 1L-Erhaltungstherapie (MTX) mit dem Poly-ADP-Ribose-Polymerase-Inhibitor (PARPi) auf den medizinischen Alltag in Deutschland erfassen, insbesondere auf: - Ergebnis der dreistufigen 1L-Behandlungsphase (einschlie\u00dflich Operation, Chemotherapie (CTX) und MTX) einschlie\u00dflich des Heilungspotenzials von Patienten mit prim\u00e4r fortgeschrittenem OC, - Patientennachsorge (FU) w\u00e4hrend und nach der MTX-Therapie, - patientenberichtete Ergebnisse (PROs), Erfahrungen und Bed\u00fcrfnisse, - Erfahrung des Arztes, - BRCA/HRD- und genomisches Narbentestverhalten bei Diagnose/w\u00e4hrend der 1L-Therapie, - Patientenauswahl f\u00fcr verschiedene systemische 1L-Behandlungsans\u00e4tze, - Einsatz und Sicherheit von Medikamenten, - Behandlungssequenz im Rezidivfall", "description_expert_en": "This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: - outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, - patient's follow-up (FU) during and after MTX therapy, - patient-reported outcomes (PROs), experiences and needs, - physician's experience, - BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, - patient selection for different 1L systemic treatment approaches, - use and safety of drugs, - treatment sequence in case of recurrence", "rechtsgrundlage_value": null, "phase_amg_value": null, "main_cat_id": 3, "sub_cat_id": 15 }