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NCT Number: NCT06143644

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. 2-year recurrence free survival rate of the cohort evaluated by ctDNA

    Time frame: 2 years post surgery

    To evaluate the correlation between circulating tumor DNA (ctDNA) detection and recurrence-free survival.

Secondary outcomes

  1. The ctDNA positive rate in stage III colorectal cancer

    Time frame: Within 4-6 week post operation

    To assess positive rate of ctDNA minimal residual disease (MRD) test in stage III of colorectal cancer patient after surgery.

  2. Time point of ctDNA MRD test for recurrence monitoring

    Time frame: Within 4-6 week post operation

    To assess time from positive ctDNA test to clinical recurrence.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Guangzhou Burning Rock Dx Co., Ltd.

Registry information

Official study title

The Predictive Value of Postoperative Circulating Tumor DNA Monitoring in Assessing the Risk of Recurrence in Stage I-IV Colorectal Cancer Patients, An Observational Study

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 22, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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