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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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In this study, the investigators aimed to apply their previously developed multi-locus blood-based assay targeting circulating tumor DNA methylation to monitor postoperative relapse and evaluate adjuvant chemotherapy efficacy in resected stage I and stage II (without high risk) colorectal cancer after radical resection.
This is a prospective, multicenter, observational, real-world study. Research objects: patients with surgically resectable colorectal cancer and ctDNA positive before surgery in stage I and stage II (without high risk). After giving fully informed consent, the participants will undergo the regular treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, postoperative week 3, postoperative 5 years ( every 3 months for the first 2 years, and every 6 months for the rest 3 years). Participants will be observed and examined during the follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDNA positive | Postoperative ctDNA positive |
| |
| ctDNA negative | Postoperative ctDNA negative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a multi-locus blood-based assay | Diagnostic Test | Colorectal tumor-specific plasma ctDNA methylation markers detection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5y DFS | The 5-year disease free survival rate of the patients from both cohorts. | 5 years |
| ctDNA methylation markers versus CT/MRI | ctDNA methylation predictors of outcome will be compared to CT/MRI | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3y DFS | The 3-year disease free survival rate of the patients from both cohorts. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 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. The written informed consent must be obtained from the patient prior to enrollment. The following criteria apply to all patients enrolled onto the study unless otherwise specified.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HongFeng cao, Ph.D | Contact | 13957117804 | hongfengcao@zju.edu.cn | |
| Rui Liu, Ph.D | Contact | rliu@singleragenomics.com |
| Name | Affiliation | Role |
|---|---|---|
| KeFeng Ding, Ph.D | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Director |
| Rui Liu, Ph.D | Singlera Genomics Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital | Recruiting | Hangzhou | Zhejiang | 310009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34487783 | Result | Cai G, Cai M, Feng Z, Liu R, Liang L, Zhou P; ColonAiQ Group; Zhu B, Mo S, Wang H, Lan X, Cai S, Xu Y, Wang R, Dai W, Han L, Xiang W, Wang B, Guo W, Zhang L, Zhou C, Luo B, Li Y, Nie Y, Ma C, Su Z. A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology. 2021 Dec;161(6):2053-2056.e2. doi: 10.1053/j.gastro.2021.08.054. Epub 2021 Sep 4. No abstract available. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |