Multiple sites all over Germany
Multiple Locations, Germany
Location status: Recruiting
NCT Number: NCT05129969
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Multiple Locations, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Routine care as per site standard.
Time frame: 3 years per patient
Documentation of anamnestic data and therapy sequences.
Time frame: 3 years per patient
Documentation of response rates per line of treatment.
Time frame: 3 years per patient
Documentation of progression-free survival per line of treatment.
Time frame: 3 years per patient
Documentation of overall survival per line of treatment.
Time frame: 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
Time frame: 3 years per patient
Functional Assessment of Cancer Therapy - Endometrial (FACT-En), a 43 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Endometrial Cancer Subscale
Contact information is provided by the study sponsor or research team.
iOMEDICO AG
Industry
SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
Acronym: SMARAGD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03452774
Adenocarcinoma, Adnexal Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06943521
Adenocarcinoma, Adnexal Diseases
Los Angeles, California, United States
View Trial DetailsNCT02288676
Adnexal Diseases, Disease
Montreal, Quebec, Canada
View Trial DetailsNCT05797168
Adenocarcinoma, Adenocarcinoma of Lung
Duarte, California, United States
View Trial Details