Registry Platform Ovarian and Endometrial Cancer

Recruiting

• Conditions: Endometrial Cancer; Ovarian Cancer; Ovary Neoplasm; Endometrial Neoplasms; Carcinoma, Ovarian; Carcinoma; Neoplasm, Ovarian
• Interventions: Other: Physician's choice according to patient's needs.

• Registration Number: NCT05129969
• Lead Sponsor: iOMEDICO AG

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.

Study Timeline

• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Start: 2021-11-25
• Status Verified: 2024-10
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1975

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ovarian cancer	Physician's choice according to patient's needs.	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	Physician's choice according to patient's needs.	Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Primary Outcome Measures

Name	Time	Method
Course of treatment (treatment reality).	3 years per patient	Documentation of anamnestic data and therapy sequences.

Secondary Outcome Measures

Name	Time	Method
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.
Best Response.	3 years per patient	Documentation of response rates per line of treatment.
Health-related quality of life (Patient-reported outcome, PRO).	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

Trial Locations

Locations (1)

Multiple sites all over Germany; 🇩🇪 Multiple Locations, Germany