Pre-Clinical Validation of ChemoINTEL Unified Algorithm Chemotherapeutic Response Prediction in Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Objective
研究概览
简要总结
This is a prospective, non-randomized, observational, pre-clinical validation study. Pierian Biosciences is utilizing ChemoINTEL assay measured in vitro cytotoxic drug induced apoptosis and cell death in isolated fresh human tumour cells from patients with colorectal cancer (CRC) to predict a patient's tumour's sensitivity to specific chemotherapy drugs using the ChemoINTEL unified algorithm. Eligible patients will be assigned to one of three groups depending on the stage of disease :
Group 1: Patients who have colorectal cancer and are referred for adjuvant chemotherapy after MDT discussion.
Group 2: Patients with stage II colorectal cancer with high risk features not referred for adjuvant chemotherapy (at risk of relapse) Group 3: Patients with locally advanced rectal cancer who have had a complete response to chemoradiotherapy (research objective).
At least one solid tumour specimen and adjacent normal tissue will be sent to Pierian Biosciences Laboratory in Liverpool, UK along with an optional 10-20ml blood sample and The Pierian Biosciences laboratory staff will conduct the ChemoINTEL and ImmunoINTEL assays blinded to all specimen and clinical information except the tumor type (e.g. Colon Cancer or Rectal Cancer), Specimen ID, and specimen collection date and time. Results of the assay will NOT be shared with clinical sites. Samples from group 3 will be provided if patients undergo surgical resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Group 1 Participants:
- •≥18 years of age
- •Diagnosis of CRC i. Surgical resection followed by adjuvant chemotherapy ii. Biopsy followed by neoadjuvant chemo/radiotherapy and surgical resection.
- •Patients planned to receive at least 6 cycles of standard of care chemotherapy for CRC with single agent or combination of drugs listed in Table 3 following biopsy OR surgical resection
- •One solid tumor specimen is required; a total of two specimens are preferred and requested when available. Specimens will include:
- •i. Primary solid tumor specimen (≥400 mg) ii. Adjacent normal tissue (>400mg)
- •Patient signed Informed Consent Form
排除标准
- •Group 1 Participants:
- •Patient has not signed an ICF to participate in a clinical investigation
- •Patient has a cancer other than advanced stage CRC
- •Patient is NOT expected to receive SOC chemotherapy, single agents or combination treatment, as listed in Table 3
- •Patients who do not have at sufficient viable cells recovered from fresh tumor dissociation available for the ChemoINTEL assay analysis of Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Capecitabine
研究组 & 干预措施
Group 3
Patients with locally advanced rectal cancer who have had a complete response to chemoradiotherapy (research objective)
Group 1
Patients who have colorectal cancer and are referred for surgical resection with adjuvant chemotherapy after MDT discussion
Group 2
Patients with stage II colorectal cancer with high risk features referred for surgical resection but not referred for adjuvant chemotherapy (at risk of relapse)
结局指标
主要结局
Primary Objective
时间窗: Approximately 4 weeks post chemotherapy completion
To evaluate Group 1 ChemoINTEL Assay Unified Algorithm's prediction accuracy of clinical response to chemotherapy in patients with minimal residual colorectal cancer disease detectable by ctDNA post-surgery (prior to Cycle 1 chemotherapy) using patient response assessed by ctDNA measured 4 weeks post chemotherapy completion
次要结局
未报告次要终点