Registry Platform Ovarian and Endometrial Cancer

Study Overview
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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.

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.

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

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

Intervention / Treatment
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* Other: Physician's choice according to patient's needs.


Participation Criteria
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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 Exclusion Criteria: newly diagnosed early-stage OC (FIGO stage I-IIa) Low grade mOC OR Early-stage EC (FIGO stage I-II)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian cancer<br>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.<br>* Routine care as per site standard.<br>|
| Endometrial cancer<br>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.<br>* Routine care as per site standard.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Response. | Documentation of response rates per line of treatment. | 3 years per patient | 
| Progression-free survival. | Documentation of progression-free survival per line of treatment. | 3 years per patient | 
| Overall survival. | Documentation of overall survival per line of treatment. | 3 years per patient | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Health service research, Epidemiology, Germany, Palliative treatment, Palliative care