National registry for ovarian and endometrial cancer patients
SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
This study is setting up a national registry to track information about patients with advanced ovarian and endometrial cancer in Germany to see how they respond to different treatments over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1975 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | iOMEDICO AG Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT05129969 on ClinicalTrials.gov |
What this trial studies
This project aims to establish a national, prospective, longitudinal tumor registry platform in Germany for patients with advanced or metastatic ovarian and endometrial cancer. It will document uniform data on patient characteristics, molecular diagnostics, treatment regimens, and disease progression while collecting patient-reported outcomes. Patients will be followed for up to three years to identify common therapeutic sequences and changes in treatment. The registry will also include a decentralized biobank to support future research.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic ovarian cancer or endometrial cancer who are starting systemic treatment.
Not a fit: Patients with early-stage ovarian or endometrial cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of treatment patterns and improve patient outcomes for those with advanced ovarian and endometrial cancers.
How similar studies have performed: Other similar registry studies have shown success in documenting treatment patterns and improving patient care, indicating this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Multiple Locations
- Multiple sites all over Germany — Multiple Locations, Germany (Recruiting)
Study contacts
- Study coordinator: iOMEDICO AG
- Email: info@iomedico.com
- Phone: +49 761 15242-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.