NCT05210283进行中（未招募）不适用
CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,017
- 试验地点
- 64
- 主要终点
- To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
研究概览
简要总结
The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Maximum duration of participant participation is up to seven years from enrollment to study completion with up to five years of active follow up and up to two years of clinical (passive) follow up.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
- •Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:
- •in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
- •histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.
- •i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
- •Pathologic stage II or III
- •ECOG performance status ≤ 2 (0, 1 or 2).
- •Able to understand and provide informed consent.
- •Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.
排除标准
- •Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
- •Pregnant or breastfeeding at time of enrollment.
- •Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
- •Prior transplant history:
- •Prior allogeneic hematopoietic stem cell transplant at any time.
- •Prior solid organ transplant within the last 2 years prior to enrollment.
- •Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
研究组 & 干预措施
Stage ll or lll
Patients with stage ll or lll colorectal cancer
干预措施: MRD (Device)
结局指标
主要结局
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
时间窗: 7 years
次要结局
- To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.(7 years)
- To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers(7 years)
- To assess time from positive ctDNA to clinical recurrence(7 years)
研究者
研究点 (64)
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