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| Name | Class |
|---|---|
| Geneplus-Beijing Co. Ltd. | INDUSTRY |
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In this study, we aim to investigate the value of circulating tumor DNA (ctDNA) analysis in the diagnosis, treatment, and surveillance of patients with surgically resectable colorectal cancer, by performing serial analysis of ctDNA, next-generation sequencing of surgical specimens, and observation of patients undergoing radical resection of the tumor with or without adjuvant chemo- and/or radiotherapy.
A prospective, observational study to determine the value of circulating tumor DNA (ctDNA) for predicting the therapeutic effects of the combined modality treatment for colorectal cancer and the patients' long-term prognosis.
Research objects: patients with surgically resectable colorectal cancer. After giving fully informed consent, the prospective participants will undergo the classical combined modality treatment according to NCCN guidelines. Serial analysis of ctDNA will be performed at specific time points including pre-treatment, (post-NCRT for NCRT patients), postoperative week 1, post-ACT, postoperative year 1, 2, and 3. The next-generation sequencing of surgical specimens will be performed as well. Participants will be observed and examined during the entire course of treatment and the follow-up period. The 3 year disease free survival (3y-DFS) will be the primary end-point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT group | Experimental | Group of patients with pathologically confirmed Stage II-III colorectal cancer who receive postoperative treatment with chemotherapeutic agent (ACT) using Capecitabine +/- Oxaliplatin. |
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| Non-ACT group | Experimental | Group of patients with pathologically confirmed stage II colorectal cancer who receive no adjuvant chemotherapy. |
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| LR group | Experimental | Group of patients with clinically staged T1-2N0 rectal cancer who undergo local resection (LR) |
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| RR group | Experimental | Group of patients with clinically staged T1-2N0 rectal cancer who undergo radical resection (RR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine +/- Oxaliplatin | Drug | Patients in ACT group will undergo postoperative adjuvant chemotherapy with single agent Capecitabine regimen or combined Capecitabine +Oxaliplatin regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| 5y DFS | The 5-year disease free survival rate of the patients. | 5 years |
| 5y LR | The 5-year local recurrence rate of the patients. | 5 years |
| 5y OS | The 5-year overall survival rate of the patients. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of ctDNA level after surgery | Changes of patients' ctDNA level after undergoing surgical resection of the tumor. | 1 month |
| Changes of ctDNA level after adjuvant therapy | Changes of patients' ctDNA level after receiving adjuvant therapy (eg. adjuvant chemothearpy). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaolin Zhou, MD | Contact | 8613910136704 | conniezhjl@yahoo.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25654990 | Background | Reinert T, Scholer LV, Thomsen R, Tobiasen H, Vang S, Nordentoft I, Lamy P, Kannerup AS, Mortensen FV, Stribolt K, Hamilton-Dutoit S, Nielsen HJ, Laurberg S, Pallisgaard N, Pedersen JS, Orntoft TF, Andersen CL. Analysis of circulating tumour DNA to monitor disease burden following colorectal cancer surgery. Gut. 2016 Apr;65(4):625-34. doi: 10.1136/gutjnl-2014-308859. Epub 2015 Feb 4. | |
| 2779946 |
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| local resection | Procedure | Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma |
|
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| radical resection | Procedure | Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma |
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| No adjuvant chemotherapy | Other | Patients in Non-ACT group will not undergo postoperative adjuvant chemotherapy. |
|
| 6 months |
| Changes of ctDNA level when disease recurs | Changes of patients' ctDNA level after disease recurrence happens | 5 year |
| Background |
| Stroun M, Anker P, Maurice P, Lyautey J, Lederrey C, Beljanski M. Neoplastic characteristics of the DNA found in the plasma of cancer patients. Oncology. 1989;46(5):318-22. doi: 10.1159/000226740. |
| 27384348 | Background | Tie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219. |
| 27459628 | Background | Zhou J, Chang L, Guan Y, Yang L, Xia X, Cui L, Yi X, Lin G. Application of Circulating Tumor DNA as a Non-Invasive Tool for Monitoring the Progression of Colorectal Cancer. PLoS One. 2016 Jul 26;11(7):e0159708. doi: 10.1371/journal.pone.0159708. eCollection 2016. |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C519688 | XELOX |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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