SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Multiple sites all over Germany
RECRUITING
Multiple Locations
Contact Information
Primary
iOMEDICO AG
info@iomedico.com
+49 761 15242-0
Time Frame
Start Date: 2021-11-25
Estimated Completion Date: 2030-12
Participants
Target number of participants: 1975
Treatments
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.
Endometrial cancer
Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
Related Therapeutic Areas
Sponsors
Leads: iOMEDICO AG

This content was sourced from clinicaltrials.gov

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