Registry Platform Ovarian and Endometrial Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1975 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-25

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ovarian Cancer Endometrial Cancer Ovary Neoplasm Endometrial Neoplasms Carcinoma, Ovarian Carcinoma Neoplasm, Ovarian

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Physician's choice according to patient's needs.

Intervention Type OTHER

Routine care as per site standard.

Endometrial cancer

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

Physician's choice according to patient's needs.

Intervention Type OTHER

Routine care as per site standard.

Interventions

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Physician's choice according to patient's needs.

Routine care as per site standard.

Intervention Type OTHER

Eligibility Criteria

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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