SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- iOMEDICO AG
- 入组人数
- 1,975
- 试验地点
- 1
- 主要终点
- Course of treatment (treatment reality).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •newly diagnosed early-stage OC (FIGO stage I-IIa)
- •Low grade mOC OR
- •Early-stage EC (FIGO stage I-II)
研究组 & 干预措施
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.
干预措施: Physician's choice according to patient's needs. (Other)
Endometrial cancer
Female patients with locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
干预措施: Physician's choice according to patient's needs. (Other)
结局指标
主要结局
Course of treatment (treatment reality).
时间窗: 3 years per patient
Documentation of anamnestic data and therapy sequences.
次要结局
- Progression-free survival.(3 years per patient)
- Overall survival.(3 years per patient)
- Best Response.(3 years per patient)
- Health-related quality of life (Patient-reported outcome, PRO).(3 years per patient)