Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence

NCT06143644 | Active Not Recruiting

• 1 other identifier: pilotCRC-MRD
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

circulating tumor DNA; recurrence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The ctDNA positive rate in stage III colorectal cancer

  Within 4-6 week post operation

• Time point of ctDNA MRD test for recurrence monitoring

  Within 4-6 week post operation

Study Arms (1)

Cohort

Patients with stage I to IV colorectal cancer

Other: Serial ctDNA monitoring

Interventions

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.

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage I-IV colorectal cancer with curative intent.

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• History of concurrent or prior malignancies (excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin).
• Patients who have received neoadjuvant therapy.
• Patients with other severe diseases that may affect follow-up and short-term survival, as determined by the investigator.
• Any other medical, social, or psychological conditions that, in the opinion of the investigator, would make the patient unsuitable for participation in this study.
• Inability to undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 30207593 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.

  PMID: 32133645 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.

  PMID: 18473145 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.

  PMID: 31070691 BACKGROUND

• 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.

  PMID: 41177967 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Tissue

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gong Chen, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: January 15, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)