OVArian Cancer Non-Interventional Study. Treatment hAbits and Epidemiology of BRCA in Russian Federation - OVATAR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 503
- 试验地点
- 1
- 主要终点
- Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen)
研究概览
简要总结
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess 1st line treatment management and diagnostic approaches applied to ovarian, peritoneal and fallopian tube cancer management in Russia and assess patients' characteristics and the occurrence of BRCA (Breast Cancer gene) mutations among Russian women with serous and endometrioid ovarian, peritoneal and fallopian tube cancer. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
详细描述
This is a multicentre, non-interventional, prospective study to be carried out in representative hospitals in order to assess ovarian, fallopian tube and peritoneal cancer management in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.
It is planned to enrol 300 subjects in up to 30 sites in Russian Federation. The average number of patients per site is planned as 10-15; there are no restrictions on minimum and maximum number of subjects per site in this study.
The disease treatments approaches in 1st line treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (both chemotherapy and surgery) is considered as the primary outcome variable in this study.
Along with other diagnosis examinations the analysis of frequent mutations in the gen BRCA1 (5382insC, 4154delA, 185delAG and C61G (c.300T>G)) will be performed by local or regional laboratories.
Those patients with BRCAm+ OC (Ovarian Cancer) will be observed prospectively during 2 years after the baseline visit or till progression at the 1st line treatment with regards to OC treatment details and outcomes. The patients for whom BRCA mutations not found will participate in the baseline assessments only and will not be followed up. Accordingly, 1 study visit (screening/baseline) is planned for all patients and 1 FU visit (Year 2) is planned for BRCAm+ patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The voluntary obtained informed consent signed by both the subject and the investigator.
- •Confirmed serous and endometrioid ovarian cancer or fallopian tube cancer or peritoneal cancer diagnosed 3 months before enrolment into the study or later
- •Patients on treatment for OC (Ovarian Cancer) or FTC (Fallopian Tube Cancer) or PC (Peritoneal Cancer)
排除标准
- •The ovarian cancer histology other than serous and endometrioid.
- •Patients participating in clinical studies.
- •Any medical condition which on the opinion of the investigator may interfere the patient's participation in the trial.
结局指标
主要结局
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN (International Nonproprietary Name), doses, regimen)
时间窗: up to 14 months
Evaluation of 1st line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen)
次要结局
- Data collection of patients characteristics (gender, age, race, co-morbidities, family history of ovarian and breast cancer)(up to 14 months)
- Assessment of relapses after 1st line of Pt (Platinum)-containing regimen for BRCAm+ patients(up to 3 months)
- Evaluation of response to 1st line chemotherapy treatment of serous and endometrioid BRCAm+ ovarian, peritoneal and fallopian tube cancer(up to 3 months)
- Evaluation of 2nd line chemotherapy treatment of serous and endometrioid ovarian, peritoneal and fallopian tube cancer (drugs by INN, doses, regimen) for BRCAm+ patients who have progressed after 1st line chemotherapy(up to 3 months)
- Data collection of disease information (including genetic testing results)(up to 14 months)
- Proportion of BRCAm+ among serous and endometrioid ovarian, peritoneal and fallopian tube cancer in Russia.(up to 14 months)