Clinical trial NCT05129969: Registry Platform Ovarian and Endometrial Cancer
Official title: SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Endometrial Cancer
Ovary Neoplasm
Endometrial Neoplasms
Carcinoma, Ovarian
Carcinoma
Neoplasm, Ovarian
Keywords: Registry
Health service research
Epidemiology
Germany
Palliative treatment
Palliative care
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 1975
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Course of treatment (treatment reality).
timeFrame: 3 years per patient
Secondary outcomes:
measure: Best Response.
timeFrame: 3 years per patient
measure: Progression-free survival.
timeFrame: 3 years per patient
measure: Overall survival.
timeFrame: 3 years per patient
measure: Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient
measure: Health-related quality of life (Patient-reported outcome, PRO).
timeFrame: 3 years per patient
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over Germany
Study officials:
affiliation: Ravensburg
name: Thomas Decker, Prof.Dr.
role: STUDY_CHAIR
affiliation: Freiburg
name: Ingolf Juhasz-Böss, Prof.Dr.
role: STUDY_CHAIR
affiliation: Aachen
name: Elmar Stickeler, Prof.Dr.
role: STUDY_CHAIR
affiliation: Freiburg
name: Dirk Watermann, Prof.Dr.
role: STUDY_CHAIR
affiliation: Essen
name: Anja Welt, Dr.
role: STUDY_CHAIR
affiliation: Würzburg
name: Achim Wöckel, Prof.Dr.
role: STUDY_CHAIR
References: