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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ovarian cancer | Female patients with high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
|
| |
| Endometrial cancer | Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician's choice according to patient's needs. | Other | Routine care as per site standard. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Course of treatment (treatment reality). | Documentation of anamnestic data and therapy sequences. | 3 years per patient |
| 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. |
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Inclusion Criteria:
Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):
Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
Signed and dated informed consent (IC):
Exclusion Criteria:
Ovarian or endometrial cancer.
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Adult female patients with (metastatic) ovarian cancer (FIGO stage IIb-IV) or (metastatic) endometrial cancer (FIGO stage III-IV) starting systemic treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| iOMEDICO AG | Contact | +49 761 15242-0 | info@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Decker, Prof.Dr. | Ravensburg | Study Chair |
| Ingolf Juhasz-Böss, Prof.Dr. | Freiburg | Study Chair |
| Elmar Stickeler, Prof.Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple sites all over Germany | Recruiting | Multiple Locations | Germany |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| 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 |
| Aachen |
| Study Chair |
| Dirk Watermann, Prof.Dr. | Freiburg | Study Chair |
| Anja Welt, Dr. | Essen | Study Chair |
| Achim Wöckel, Prof.Dr. | Würzburg | Study Chair |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |