Actively Recruiting
Led by Gene Solutions ยท Updated on 2024-09-19
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
Researchers are conducting a prospective observational study to evaluate circulating tumor DNA (ctDNA) levels in blood samples of patients with stage II-III rectal cancer undergoing total neoadjuvant therapy (TNT). The study aims to assess ctDNA detection rates before, during, and after TNT, explore the relationship between ctDNA and imaging results with pathological complete response (pCR), and examine how post-TNT ctDNA levels relate to disease-free survival. Participants will have blood samples collected at three key timepoints: before TNT, mid-treatment, and after TNT but before surgery, to analyze ctDNA changes. Additionally, tumor biopsy samples are collected before treatment and after surgery to compare mutational profiles. The study also gathers clinical data including MRI/CT scan images, tumor stage, and pathology reports to correlate with ctDNA and treatment response. During the study, participants will undergo blood draws and imaging assessments at specified intervals, along with clinical evaluations and pathological examinations of tumor tissue. Researchers will monitor disease-free survival for two years following treatment. Outcome measures include ctDNA detection rates, correlation with imaging and pathological response, and long-term survival data, providing a comprehensive picture of ctDNA's role in monitoring TNT efficacy.
CONDITIONS
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of total neoadjuvant therapy (several months)
Participants provide blood samples for ctDNA analysis and tumor biopsy slides at specified time points before, during, and after total neoadjuvant therapy (TNT). MRI and/or CT scans are performed to monitor tumor status.
3 visits for blood sample collection and imaging (pre-TNT, mid-treatment, post-TNT before surgery)
Duration - Surgery day plus immediate postoperative period
Participants undergo surgery to remove the tumor, and tumor samples are collected during surgery for pathological evaluation.
1 visit (surgery and sample collection)
Duration - 2 years
Participants are followed for up to 2 years after surgery to monitor disease-free survival and clinical outcomes.
Periodic follow-up visits over 2 years
Total: 1 location
1
Medical Genetics Institute
Ho Chi Minh City, Vietnam
Actively Recruiting
L
Lan NL Tu, PhD
V
Van T Phan, MSc
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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