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ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer

Recruitingn/aAges 18 Years - 80 YearsAllGene Solutions
NCT06589388 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 s

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Medical Genetics Institute
Ho Chi Minh City, Vietnam
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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