Actively Recruiting
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
Led by Gene Solutions · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective observational study with three primary objectives: Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before, during, and after total neoadjuvant therapy (TNT). Determine the detection rate and change of CtDNA in blood samples of cancer patients before, during, and after TNT then assess changes in ctDNA expression within the study population during treatment. * Determine the ctDNA positivity rate before treatment. * Determine the ctDNA positivity rate during TNT. * Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment. Objective 2: Investigate the relationship between ctDNA expression and MRI/CT scan imaging with the pathological complete response (pCR) to neoadjuvant therapy : * Correlation between ctDNA detection and pCR/TRG/NAR score. Calculate the Positive Prediction Value - PPV, Negative Prediction Value - NPV of ctDNA, * Correlation between MRI/CT scan imaging and pCR. Calculate the PPV and NPV of MRI/CT scan * Combination of ctDNA detection and MRI/CT scan imaging to predict pCR. Calculate the PPV and NPV of the combined markers. Objective 3: Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients.
CONDITIONS
Official Title
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older, any gender
- Diagnosed with stage II or III rectal cancer and planned for total neoadjuvant therapy
- Biopsy FFPE tissue sample available at diagnosis
- Provided consent to participate in the study
You will not qualify if you...
- Diagnosed with stage I rectal cancer, recurrent disease, or metastatic cancer
- Presence of other cancers that have spread to the rectum
- Recommended to receive chemoradiation therapy only
- Have been or are currently being treated for cancer
- Do not agree to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical Genetics Institute
Ho Chi Minh City, Vietnam
Actively Recruiting
Research Team
L
Lan NL Tu, PhD
CONTACT
V
Van T Phan, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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