Analyzing tumor and blood samples in colorectal cancer patients
ctDNA Monitoring Cancer Recurrence and Its Clinical Value in Solid Tumor
This study is trying to see how levels of tumor DNA in the blood relate to treatment results in people with stage II-III colorectal cancer after their surgery and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Shandong First Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06028516 on ClinicalTrials.gov |
What this trial studies
This observational study collects tumor and adjacent tissue samples from colorectal cancer patients to perform whole exome sequencing (WES). Following surgery, blood samples will be taken at various intervals (1, 3, 6, 9, 12, 18, and 24 months) to detect circulating tumor DNA (ctDNA). The study aims to understand the relationship between ctDNA levels and treatment outcomes in patients who have undergone surgery and chemotherapy for stage II-III colorectal cancer. Proper sample handling and storage protocols are emphasized to ensure the integrity of the collected data.
Who should consider this trial
Good fit: Ideal candidates are patients aged 30-80 with stage II-III colorectal cancer who have undergone surgery and are receiving conventional chemotherapy.
Not a fit: Patients with serious comorbidities or other malignancies within the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve monitoring and treatment strategies for colorectal cancer patients by providing insights into ctDNA dynamics post-surgery.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring cancer treatment responses, indicating that this approach is gaining traction in oncology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) Patients with colorectal tumors, whose clinical symptoms meet the diagnostic criteria of colon cancer in my country, and pathologically diagnosed as colorectal cancer after surgery; (2) patients with stage II-III colorectal cancer; (3) aged 30-80 years; (4) All underwent conventional radiotherapy and chemotherapy after operation; (5) Complete clinical data and follow-up records were available. Exclusion Criteria: * (1) Other serious diseases (cardiovascular and cerebrovascular diseases, kidney diseases, etc.) before operation; (2) Combined with multiple primary colorectal cancers; (3) Patients with other malignant tumors within the past 5 years; (4) Combined with digestive tract Obstruction, perforation, bleeding and other indications for emergency surgery.
Where this trial is running
Jinan, Shandong
- Jinan central hospital affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Manfei Liang, PhD
- Email: manfeiliang@sina.com
- Phone: 0531-59556161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.