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| Name | Class |
|---|---|
| Guangzhou Burning Rock Dx Co., Ltd. | INDUSTRY |
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This observational study aims to assess the predictive value of postoperative circulating tumor DNA (ctDNA) monitoring in evaluating the risk of recurrence in stage I-IV colorectal cancer patients. The study involves the collection of blood samples from patients who have undergone surgery for colorectal cancer. Sensitivity-enhanced molecular biology techniques are utilized to detect ctDNA in these samples. The correlation between ctDNA detection and the risk of recurrence is evaluated by analyzing patient follow-up data and clinical information. The findings of this study may contribute to the development of improved postoperative management strategies, such as identifying high-risk individuals and implementing additional treatment measures to reduce the risk of recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Patients with stage I to IV colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serial ctDNA monitoring | Other | Baseline blood samples, surgical resected tumor tissue, blood samples after surgery (D5-7), blood samples before adjuvant therapy and blood samples after adjuvant therapy (every 3 months for up to 2 years follow-up) will be collected from colorectal patients. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year recurrence free survival rate of the cohort evaluated by ctDNA | To evaluate the correlation between circulating tumor DNA (ctDNA) detection and recurrence-free survival. | 2 years post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The ctDNA positive rate in stage III colorectal cancer | To assess positive rate of ctDNA minimal residual disease (MRD) test in stage III of colorectal cancer patient after surgery. | Within 4-6 week post operation |
| Time point of ctDNA MRD test for recurrence monitoring |
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Inclusion Criteria:
Age ≥ 18 years at the time of signing the informed consent form.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
Histologically confirmed colorectal cancer located from the ileocecal junction to the rectosigmoid junction, with a distance of >15cm from the anal verge. Regardless of mismatch repair (MMR) status, Rat sarcoma (RAS) gene and proto-oncogene serine/threonine-protein kinase (RAF) gene status.
Pathologically or cytologically confirmed American Joint Committee on Cancer (AJCC) tumor node metastasis (TNM) stage I-IV colorectal cancer patients (8th edition).
No evidence of distant metastasis confirmed by comprehensive examination (no distant organ or lymph node metastasis).
Normal organ function, as indicated by the following criteria:
Ability to provide clinical data required for the study.
Sufficient tumor tissue available for analysis.
Patients capable of achieving R0 radical resection.
Patients capable of adhering to the planned schedule, actively participating in regular clinical follow-up, and necessary treatments.
Exclusion Criteria:
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Stage I-IV colorectal cancer with curative intent.
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| Name | Affiliation | Role |
|---|---|---|
| Gong Chen, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30207593 | Background | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. | |
| 32133645 | Background | Siegel RL, Miller KD, Goding Sauer A, Fedewa SA, Butterly LF, Anderson JC, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020 May;70(3):145-164. doi: 10.3322/caac.21601. Epub 2020 Mar 5. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Blood, Tissue
|
To assess time from positive ctDNA test to clinical recurrence. |
| Within 4-6 week post operation |
| 18473145 | Background | Govindarajan A, Fraser N, Cranford V, Wirtzfeld D, Gallinger S, Law CH, Smith AJ, Gagliardi AR. Predictors of multivisceral resection in patients with locally advanced colorectal cancer. Ann Surg Oncol. 2008 Jul;15(7):1923-30. doi: 10.1245/s10434-008-9930-1. Epub 2008 May 13. |
| 31070691 | Background | Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528. |
| 41177967 | Derived | Cao D, Lv GZ, Li C, Wang FL, Zhou QX, Cai SL, Wu XJ, Jiang W, Yang X, Liu YF, Wu MQ, Li LR, Lu ZH, Pan ZZ, Lin JZ, Kong LH, Ding PR, Zhang DY, Yang JB, Lu SX, Peng JH, Mei WJ, Chen S, Sun Q, Chen SQ, Wan DS, Fan XN, Wang GQ, Li CC, Sun Y, Wu SL, Zhang ZH, Zhang RX, Chen G. Association of Recurrence with a Tumor-informed Personalized ctDNA Detection Approach in Resectable Colorectal Cancer: Results of a Prospective Observational Study. Ann Surg. 2025 Nov 3. doi: 10.1097/SLA.0000000000006971. Online ahead of print. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |