NCT06398743进行中（未招募）不适用
CORRECT-MRD I: First Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 416
- 试验地点
- 22
- 主要终点
- To validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death.
研究概览
简要总结
The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.
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
- •Subject is/has:
- •18 years of age or older.
- •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 form 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 CRC.
- •ECOG performance status ≤ 2 (0, 1 or 2).
- •Able to understand and provide written informed consent.
- •Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.
排除标准
- •Subject is/has:
- •Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
- •Known pregnancy 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.
结局指标
主要结局
To validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death.
时间窗: 6 years
次要结局
- Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.(6 years)
研究者
研究点 (22)
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