NCT05733793招募中不适用
A Retrospective-prospective, Multicenter, Observational Study Aimed to Record Molecular Data and to Explore Their Correlations With Clinical Outcomes in Gynecological Cancer Patients. The MITO GYNecological Cancers GEnetic Profile Registry (GYNGER) Study.
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The proportion of different gene alterations found with NGS tests
研究概览
简要总结
Gynger is a no profit, observational study, composed of a retrospective cohort (A) and a prospective cohort (B). The primary aim of this trial is to describe gene profile of Italian gynecological cancers patients, through the centralization of NGS reports performed in clinical practice or collected in clinical trials, and to correlation them with clinical and pathologic features.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Signed informed consent form;
- •Female sex;
- •Age ≥18 years;
- •Diagnosis of a gynecological malignancy (ovarian cancer, uterine cancer, vulvar-vaginal cancer, gestational trophoblastic tumor);
- •Availability of NGS report performed on solid tumor tissue from primary or recurrent disease or liquid biopsy; data from NGS assays both in-house (academic test) and commercials can be used regardless of the number of genes analyzed
排除标准
- •Patients for which the NGS analysis has been performed of germline tissue
结局指标
主要结局
The proportion of different gene alterations found with NGS tests
时间窗: 4years
This percentage will be calculated within enrolled patients that have a report of NGS test at baseline
次要结局
- Progression-free-survival (PFS)(until progression disease (up to 4 years))
- Overall survival (OS)(4 years)
- ORR(4 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in RussiaSystemic Lupus ErythematosusNCT06759519AstraZeneca637
已完成
不适用
Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's SyndromeCushing's SyndromeNCT05633953RECORDATI GROUP103
已完成
不适用
PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of RussiaArterial Hypertension, Chronic Kidney DiseaseNCT06372431AstraZeneca9,914
已完成
不适用
Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous PemphigoidBullous PemphigoidNCT02837965CHU de Reims149
招募中
不适用
Evaluation of Enavogliflozin's Efficacy and Safety in Type II Diabetes With Hypertension or DyslipidemiaDiabetes Mellitus, Type 2NCT06647888Daewoong Pharmaceutical Co. LTD.12,000