ISRCTN59698923进行中（未招募）未知
PArp Inhibitor Resistance Study
HS Greater Glasgow and Clyde0 个研究点目标入组 260 人开始时间: 2022年4月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- Female
入选标准
- •All patients:
- •1. Age =16 years
- •2. Histological diagnosis of high-grade serous, high-grade endometrioid or carcinosarcoma of the ovary, primary peritoneum or fallopian tube
- •3. Availability of formalin-fixed, paraffin-embedded tissue taken at the time of original diagnosis of high grade serous ovarian cancer. This may be primary surgical debulking specimen OR core biopsy. For those with only a core biopsy from time of diagnosis, availability of specimen taken at interval debulking surgery is also requested.
- •4. Prior treatment with a PARP inhibitor or about to commence maintenance PARPi therapy (cohort A). PARPi can be single agent or in combination with bevacizumab. If PARPi is in combination with a different agent as part of a clinical trial, the patient may still be eligible but this should be confirmed with the Cancer Research UK Glasgow Clinical Trials Unit prior to patient registration.
- •1. Patients need to be progression free (defined by no evidence of GCIG Ca125 progression or radiological progression)
- •2. No contraindication to biopsy
- •3. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed
- •4. Willingness to comply with trial procedures
- •5. Life expectancy >3 months
- •1. Patients need to have radiologically-defined progressive disease on PARPi
- •2. Patients must have disease deemed suitable for imaging-guided biopsy (ultrasound or CT) by an experienced radiologist or suitable for intra-operative biopsy during secondary debulking surgery as determined by an experienced gynaecological oncology surgeon. Other biopsies, such as skin deposits, are also acceptable. However, this must be confirmed with the Cancer Research UK Glasgow Clinical Trials Unit prior to patient registration (for cohort B).
- •3. No contraindication to biopsy
- •4. No systemic anti-cancer treatment (SACT) commenced post-PARPi (patients continuing PARPi after surgical resection of a progressing lesion can be included)
- •5. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed
- •6. Willingness to comply with trial procedures
- •7. Life expectancy >3 months
- •1. Patients need to have had a lesion which radiologically progressed on PARPi
- •2. Archival tumour of a lesion progressing post PARPi must be available
- •3. Ability to provide written informed consent prior to participating in the study and any study-related procedures being performed. Patients with available archival pre and post-PARPi tumour samples, who are no longer living may be identified by their clinical team and registered for the study if samples were collected under generic research consent (or equivalent).
排除标准
- •1. Ovarian, primary peritoneal or fallopian tube cancer of low grade serous, grades 1 or 2 endometrioid, clear cell or mucinous subtypes
- •2. Borderline/low malignant potential tumours
- •3. Any non-epithelial ovarian malignancy
- •4. Original diagnosis of high-grade serous cancer made on cytology only
- •5. Discontinued PARPi for toxicity within 3 months of starting PARPi
- •6. Any other severe concurrent disease which may increase the risk associated with trial participation
- •7. Any psychological, familial, sociological or geographical considerations potentially hampering compliance with the trial and follow-up schedule
研究者
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