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NCT Number: NCT05129969

Registry Platform Ovarian and Endometrial Cancer

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Physician's choice according to patient's needs.

Other

Routine care as per site standard.

Primary outcomes

  1. Course of treatment (treatment reality).

    Time frame: 3 years per patient

    Documentation of anamnestic data and therapy sequences.

Secondary outcomes

  1. Best Response.

    Time frame: 3 years per patient

    Documentation of response rates per line of treatment.

  2. Progression-free survival.

    Time frame: 3 years per patient

    Documentation of progression-free survival per line of treatment.

  3. Overall survival.

    Time frame: 3 years per patient

    Documentation of overall survival per line of treatment.

  4. Health-related quality of life (Patient-reported outcome, PRO).

    Time frame: 3 years per patient

    Functional Assessment of Cancer Therapy - Ovarian (FACT-O), a 39 item questionnaire covering Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being and Ovarian Cancer Subscale

  5. Health-related quality of life (Patient-reported outcome, PRO).

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

iOMEDICO AG

CONTACT

[email protected]

+49 761 15242-0

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: SMARAGD

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Nov 22, 2021
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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