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This is a prospective, clinical study. This study is to evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
Colorectal cancer (CRC) is the third most common cancer worldwide, the second deadliest cancer in the United States. DNA methylation is a commonly used biomarker for non-invasive CRC detection in plasma. The low sensitivity of blood-based tests is due to several limitations of detecting ctDNA in early-stage cancer. We developed and validated a high-throughput methylation-based blood test highly sensitive for colorectal cancer and precancerous lesions. This previously established colorectal tumor-specific plasma ctDNA methylation markers (diagnostic model established by next-generation sequencing of 2181 gene loci methylation) had a high sensitivity in CRC patients and a high specificity in healthy individuals in a large retrospective sample study. This prospective, clinical study is to further evaluate the sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with endoscopically removed malignant polyps | Patients with endoscopically removed malignant polyps |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next-generation sequencing (NGS) | Diagnostic Test | NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy and before surgical resection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The sensitivity of plasma ctDNA methylation haplotypes in detecting local residual or lymph node metastasis | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with endoscopically removed malignant polyps must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxiang Cai, M.D. Ph.D. | Contact | +86 13611831623 | gxcai@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |