A Retrospective/Prospective Study of an Artificial Intelligence Derived Histological Biomarker to Select Neoadjuvant Treatment for Patients With Borderline Resectable or Resectable Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Retrospective prediction of pCR in borderline resectable patients
研究概览
简要总结
To collect samples and information from patients who will be undergoing standard of care neoadjuvant treatment with either FOLFIRINOX or Gemcitabine + Nab-paclitaxel.
The information collected will be used to determine if there are any "biomarkers" in your blood or tumor tissue that, when compared to your response to the neoadjuvant treatment, could be used to choose the best treatment option for future patients with similar biomarkers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed PDAC that is borderline resectable (BR) (Cohort A) OR have histologically or cytologically confirmed PDAC that is resectable (Cohort B) using the National Comprehensive Cancer Network criteria [35].
- •Availability of archival tumor tissue (diagnostic for PDAC) required
- •Have a documented ECOG Performance Status of ≤ 1
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form (ICF) prior to receiving any study related procedure.
排除标准
- •Has received prior systemic treatment (standard of care or experimental) for PDAC
- •Participant has a concurrent malignancy requiring active treatment during the study.
研究组 & 干预措施
Patients with Borderline Resectable (Cohort A)
Pathological response of Patients with borderline resectable disease (per NCCD Criteria) treated with standard care chemotherapy
干预措施: Blood sample (Other)
Patients with Resectable (Cohort B)
Pathological response of Patients with resectable disease (per NCCN criteria) treated with standard care chemotherapy
干预措施: Blood sample (Other)
结局指标
主要结局
Retrospective prediction of pCR in borderline resectable patients
时间窗: Up to 2 years
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended). Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended)
Retrospective prediction of pCR in resectable patients
时间窗: Up to 2 years
Pathologic response is based on the American College of Pathology Criteria. The AI classified treatment is based on the best representative slide analyzed by the Valar Labs AI algorithm for V-FFX (is Folfirinox recommended) and V-GNP (is GEM/NAB-Paclitaxel recommended
次要结局
- Survival status(Up to 2 years)
- RECIST 1.1 response(UP to 2 years)