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This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.
Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colorectal cancer arm |
| ||
| Healthy control arm |
| ||
| Intestinal polyp arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miRNA detection test | Device | miRNA sequencing based on Next-Generation Sequencing (NGS) technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients | 24 months |
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Inclusion Criteria:
Inclusion Criteria for the colorectal cancer arm:
1.18-75 years old 2. Pathologically confirmed as colorectal adenocarcinoma 3. Medically able to receive radical surgery for colorectal cancer 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 to 1 5. Ability to provide a written informed consent
Inclusion Criteria for the healthy control arm:
1.18-75 years old 2. No clinically significant finding based on routine blood tests, urinalysis, CT, and ultrasound examinations 3. Ability to provide a written informed consent
Inclusion Criteria for the intestinal polyp arm:
1.18-75 years old 2. Pathologically confirmed as colorectal adenoma 3. Ability to provide a written informed consent
Exclusion Criteria:
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Eligible participants will be recruited from medical centers and assigned into three arms, including participants with new diagnosis of colorectal adenocarcinoma, participants with intestinal polyp, and healthy control.
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Peripheral Blood
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |