Registry Platform Ovarian and Endometrial Cancer
SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
iOMEDICO AG
1,975 participants
Nov 25, 2021
OBSERVATIONAL
Conditions
Summary
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.
Eligibility
Inclusion Criteria7
- Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
- patients with FIGO stage IIb-IV OC who are starting systemic treatment or
- patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.
- Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
- Signed and dated informed consent (IC):
- Patients participating in PRO module: IC before first therapy cycle
- Patients not participating in PRO module: IC no later than six weeks after start of first therapy cycle
Exclusion Criteria3
- newly diagnosed early-stage OC (FIGO stage I-IIa)
- Low grade mOC OR
- Early-stage EC (FIGO stage I-II)
Interventions
Routine care as per site standard.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05129969