Carcinoma, Carcinoma, Ovarian, Endometrial Cancer, Endometrial Neoplasms, Neoplasm, Ovarian, Ovarian Cancer, Ovary Neoplasm
Conditions
Keywords
Registry, Health service research, Epidemiology, Germany, Palliative treatment, Palliative care
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.
Interventions
Routine care as per site standard.
Sponsors
iOMEDICO AG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Course of treatment (treatment reality). | 3 years per patient | Documentation of anamnestic data and therapy sequences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Response. | 3 years per patient | Documentation of response rates per line of treatment. |
| Progression-free survival. | 3 years per patient | Documentation of progression-free survival per line of treatment. |
| Overall survival. | 3 years per patient | Documentation of overall survival per line of treatment. |
| Health-related quality of life (Patient-reported outcome, PRO). | 3 years per patient | Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale |
Countries
Germany
Contacts
CONTACTiOMEDICO AG
STUDY_CHAIRThomas Decker, Prof.Dr.
Ravensburg
STUDY_CHAIRIngolf Juhasz-Böss, Prof.Dr.
Freiburg
STUDY_CHAIRElmar Stickeler, Prof.Dr.
Aachen
STUDY_CHAIRDirk Watermann, Prof.Dr.
Freiburg
STUDY_CHAIRAnja Welt, Dr.
Essen
STUDY_CHAIRAchim Wöckel, Prof.Dr.
Würzburg
Outcome results
None listed