Registry Platform Ovarian and Endometrial Cancer (SMARAGD)

iOMEDICO

Status: Enrolling

Conditions: Endometrial Cancer; Carcinoma, Ovarian; Neoplasm, Ovarian; Carcinoma; Ovarian Cancer; Endometrial Neoplasms; Ovary Neoplasm

Treatments: Other: Physician's choice according to patient's needs.

Study type: Observational

Funder types: Industry

Identifiers

NCT05129969

IOM-110401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,975 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,975 participants in 2 patient groups

Ovarian cancer

Description:

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.

Treatment:

Other: Physician's choice according to patient's needs.

Endometrial cancer

Description:

Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.

Treatment:

Other: Physician's choice according to patient's needs.