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Study identifier: NCT06589388 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer

Condition: Rectal Cancer · Rectal Cancer Stage II · Rectal Cancer Stage III  ·  Sponsor: Gene Solutions

PhaseN/A
Planned participants100
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Lan NL Tu, PhD  ·  +84888843489  ·  lantu@genesolutions.vn

Van T Phan, MSc  ·  +84908145990  ·  vanphan@genesolutions.vn

Always discuss trial participation with your own doctor first.

Locations (1)

Medical Genetics InstituteHo Chi Minh City, VietnamRecruiting

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Source record: clinicaltrials.gov/study/NCT06589388