SMARAGD: Registry Platform Ovarian and Endometrial Cancer

Sponsor

iOMEDICO AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05129969

Collaborator

(none)

1,300

Enrollment

Location

72.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer Endometrial Cancer Ovary Neoplasm Endometrial Neoplasms Carcinoma, Ovarian Carcinoma Neoplasm, Ovarian	Other: Physician's choice according to patient's needs.

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1300 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 25, 2021

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Physician's choice according to patient's needs. 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.	Other: Physician's choice according to patient's needs. Routine care as per site standard.

Arm

Intervention/Treatment

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.

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

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.

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

Routine care as per site standard.

Outcome Measures

Primary Outcome Measures

Course of treatment (treatment reality). [3 years per patient]
Documentation of anamnestic data and therapy sequences.

Secondary Outcome Measures

Best Response. [3 years per patient]
Documentation of response rates per line of treatment.
Progression-free survival. [3 years per patient]
Documentation of progression-free survival per line of treatment.
Overall survival. [3 years per patient]
Documentation of overall survival per line of treatment.
Health-related quality of life (Patient-reported outcome, PRO). [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
Health-related quality of life (Patient-reported outcome, PRO). [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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