SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
Overview
- Phase
- N/A
- Intervention
- Physician's choice according to patient's needs.
- Conditions
- Ovarian Cancer
- Sponsor
- iOMEDICO AG
- Enrollment
- 1975
- Locations
- 1
- Primary Endpoint
- Course of treatment (treatment reality).
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Detailed Description
SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany. The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. Health-related quality of life (HRQoL) will be evaluated for up to three years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •newly diagnosed early-stage OC (FIGO stage I-IIa)
- •Low grade mOC OR
- •Early-stage EC (FIGO stage I-II)
Arms & Interventions
Ovarian cancer
Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer): * with newly diagnosed FIGO stage IIb-IV OC who are starting systemic treatment, independent of the treatment intention (adjuvant/curative or palliative) or * with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting their systemic treatment for first recurrent/relapsed disease.
Intervention: Physician's choice according to patient's needs.
Endometrial cancer
Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
Intervention: Physician's choice according to patient's needs.
Outcomes
Primary Outcomes
Course of treatment (treatment reality).
Time Frame: 3 years per patient
Documentation of anamnestic data and therapy sequences.
Secondary Outcomes
- Progression-free survival.(3 years per patient)
- Overall survival.(3 years per patient)
- Best Response.(3 years per patient)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient)