NCT06143644Active, not recruiting
Predictive Value of Postoperative Circulating Tumor DNA Monitoring for Colorectal Cancer Recurrence
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 15 Jan 2022
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT06143644
What you commit to
- Study type: Observational
- Planned participants: 220
- From 15 Jan 2022 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received neoadjuvant therapy.
Other illness
- History of concurrent or prior malignancies (excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin).
- 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.
Other
- Inability to undergo clinical follow-up using contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.