Observational Analysis of the Association of Drug Activity Measured in Viable Tumour Tissues ex Vivo and Clinical Response in Ovarian Cancer: A Basic Research Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome
研究概览
简要总结
EXCYTE-1 is a multicentre, prospective observational study to investigate the relationship between ex vivo drug response (EVDR), measured in ovarian tumour-derived samples using high content imaging, and actual patient clinical response.
Patients with newly diagnosed or relapsed/refractory epithelial ovarian carcinoma, that present with malignant effusions (ascites or pleural effusions), will be enrolled in the study before starting their initial or next treatment line.
Enrolled patients will be asked to provide ascites, peripheral blood and fresh tumour tissue if available. Samples will be shipped to the sponsor laboratory and their response to standard of care drugs evaluated ex vivo.
Participants will:
- provide samples during routine clinical procedures
- agree that data about their medical history, diagnosis and health status at the following timepoints are collected: at signature of the consent form, at the time samples are provided, at start of the therapy, upon completion of the therapy, regularly after completion of the therapy
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 125 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Minimum age 18 years
- •Signed informed consent form
- •Confirmed diagnosis of ovarian cancer except low grade serous, clear cell and mucinous histology
- •Where patients are treatment naïve, patients need to have disease stage FIGO (International Federation of Gynecology and Obstetrics) III or FIGO IV.
- •Patient is expected to receive primary chemotherapy/maintenance after initial surgical debulking or a further line of systemic therapy in the relapsed setting according to treatment guidelines
- •Feasibility of collecting malignant ascites and/or pleural effusion during either primary debulking surgery or a routine drainage procedure prior to initiation of the first or next line of systemic therapy
- •ECOG (Eastern Cooperative Oncology Group) stage 0-2
排除标准
- •Previously study participation
- •Known or suspected HIV or active Hepatitis B and/or C infection or active COVID-19 infection
- •Anticancer treatment or radiation therapy of the region which is to be drained or biopsied within the last 4 weeks
- •Patient unfit or not willing to receive any further systemic treatment
- •Patient is treated with therapeutics not tested in the assay - with the exception of anti-VEGF (Vascular endothelial growth factor) therapy
- •Known pregnancy
- •Sample quality criteria are not met (at least 250ml of ascites available, no signes of bacterial superinfection, no additives, at least 1% EpCAM (Epithelial Cell Adhesion Molecule) positive cells, viability at least 60%)
结局指标
主要结局
Association between ex vivo drug response (EVDR) of ascites samples and clinical outcome
时间窗: From time of diagnosis (sampling) until disease progression or End of Study (EoS), whichever comes first, assessed up to 45 month.
EVDR will be compared to the clinical outcome, determined based on local practice
次要结局
- Prognostic value of EVDR of ascites samples in PFS (Progression-free survival) prediction(From diagnosis until month 6 (12) or relapse/ EoS, whatever comes first.)
- Biomarker impact on EVDR and its prognostic value(From study start to study end (up to 45 month).)
- Technical success rate(From study start to study end (up to 45 month).)