Monitoring blood markers to predict treatment response in rectal cancer
ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
This study is testing if measuring certain blood markers in patients with stage II and III rectal cancer can help predict how well they respond to treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Gene Solutions Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT06589388 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the levels of circulating tumor DNA (ctDNA) in patients with stage II and III rectal cancer undergoing total neoadjuvant therapy (TNT). Blood samples will be collected at three key time points: before treatment, during treatment, and after treatment to assess changes in ctDNA levels. The study will also investigate the correlation between ctDNA levels and imaging results to predict the pathological complete response to therapy. Participants will be monitored for disease-free survival over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage II or III rectal cancer who are eligible for total neoadjuvant therapy.
Not a fit: Patients with stage I rectal cancer, recurrent or metastatic cancer, or those not consenting to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict treatment efficacy and guide therapy decisions for rectal cancer patients.
How similar studies have performed: While the use of ctDNA monitoring in cancer treatment is gaining traction, this specific approach in rectal cancer with TNT is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older, both genders * Patients are diagnosed with stage II-III rectal cancer and indicated for total neoadjuvant therapy * Biopsy FFPE sample is available at the time of diagnosis * Patients consented to participate in the study Exclusion Criteria: * Stage I rectal cancer, recurrent or metastatic cancer * Other cancer metastasis to the rectum * Patients are indicated for chemoradiation therapy only * Have been or are being treated for cancer * Patients do not agree to participate in the studies.
Where this trial is running
Ho Chi Minh City
- Medical Genetics Institute — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Sinh D Nguyen, PhD — Medical Genetics Institude
- Study coordinator: Lan NL Tu, PhD
- Email: lantu@genesolutions.vn
- Phone: +84888843489
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.