Klinische Studie
A single arm, prospective Non- Interventional Study to collect Clinical and Patient reported outcome data in an Olaparib treated BRCAm+ PSR ovarian cancer population (C-Patrol)(C-PATROL)Einarmige, prospektive nicht-interventionelle Studie zur Erhebung klinischer von Patienten berichteten Daten, welche mit Olaparib behandelt wurden (BRCAm+ PSR-Eierstockkrebs-Population)
Krankheitsentität(en)
Weibliches Genital (z.B. Eierstock, Eileiter, Gebärmutter, Scheide, Schamlippen)
StudientypBeobachtungsstudie
StudientypBeobachtungsstudie
Wesentliche Einschlusskriterien1. Signed written informed consent
2. Women aged ≥ 18 years
3. Patients with platinum sensitive relapsed high grade epithelial ovarian Cancers (including primary peritoneal and/or fallopian tube cancer)
4. Documented BRCA mutations (germline or somatic mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function))
5. Patients should be in line with the specifications mentioned in the LYNPARZA SmPC for tablets or hard capsules.
Wesentliche Ausschlusskriterien1. Known hypersensitivity to olaparib or any of the excipients of the drug
2. Patients who have started olaparib monotherapy for more than 14 days before giving their informed consent
3. Pregnancy or breast feeding
StatusStudie beendet
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgFrauenheilkunde und Geburtshilfe Krankenhaus St JosefStudienzentrale0941 7823401fhk-studienzentrum(at)csj.de