Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence
NCT ID: NCT06143644
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
220 participants
OBSERVATIONAL
2022-01-15
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Patients with stage I to IV colorectal cancer
Serial ctDNA monitoring
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.
Interventions
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Serial ctDNA monitoring
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.
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1.
3. 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.
4. Pathologically or cytologically confirmed American Joint Committee on Cancer (AJCC) tumor node metastasis (TNM) stage I-IV colorectal cancer patients (8th edition).
5. No evidence of distant metastasis confirmed by comprehensive examination (no distant organ or lymph node metastasis).
6. Normal organ function, as indicated by the following criteria:
* Hematology criteria: For patients who have not received blood transfusion, white blood cell (WBC) ≥ 3.5/4.0 × 10\^9/L, neutrophils ≥ 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L.
* Biochemistry criteria: Crea and bilirubin (BIL) ≤ 1.0 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN, alkaline phosphatase (ALP) ≤ 2.5 × ULN, total bilirubin (Tbil) ≤ 1.5 × ULN.
7. Ability to provide clinical data required for the study.
8. Sufficient tumor tissue available for analysis.
9. Patients capable of achieving R0 radical resection.
10. Patients capable of adhering to the planned schedule, actively participating in regular clinical follow-up, and necessary treatments.
Exclusion Criteria
2. Patients who have received neoadjuvant therapy.
3. Patients with other severe diseases that may affect follow-up and short-term survival, as determined by the investigator.
4. Any other medical, social, or psychological conditions that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
5. Inability to undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
18 Years
ALL
No
Sponsors
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Guangzhou Burning Rock Dx Co., Ltd.
INDUSTRY
Sun Yat-sen University
OTHER
Responsible Party
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Gong Chen
Professor
Principal Investigators
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Gong Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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pilotCRC-MRD
Identifier Type: -
Identifier Source: org_study_id