Registry Platform Ovarian and Endometrial Cancer

Ovarian Cancer Clinical Trial

— SMARAGD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129969
• Other study ID #: IOM-110401
• Status: Recruiting
• Start date: November 25, 2021
• Est. completion date: December 2027

Study information

• Verified date: July 2023
• Source: iOMEDICO AG
• Contact: iOMEDICO AG
• Phone: +49 761 15242-0
• Email: info[@]iomedico.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Physician's choice according to patient's needs.
Routine care as per site standard.

Locations

Country	Name	City	State
Germany	Multiple sites all over Germany	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Course of treatment (treatment reality).	Documentation of anamnestic data and therapy sequences.	3 years per patient
Secondary	Best Response.	Documentation of response rates per line of treatment.	3 years per patient
Secondary	Progression-free survival.	Documentation of progression-free survival per line of treatment.	3 years per patient
Secondary	Overall survival.	Documentation of overall survival per line of treatment.	3 years per patient
Secondary	Health-related quality of life (Patient-reported outcome, PRO).	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	3 years per patient
Secondary	Health-related quality of life (Patient-reported outcome, PRO).	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	3 years per patient