NCT06589388 ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
| NCT ID | NCT06589388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gene Solutions |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-05-21 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Sinh D Nguyen, PhD
PRINCIPAL INVESTIGATOR
Medical Genetics Institude
Frequently Asked Questions
Who can join the NCT06589388 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06589388 currently recruiting?
Yes, NCT06589388 is actively recruiting participants. Contact the research team at lantu@genesolutions.vn for enrollment information.
Where is the NCT06589388 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06589388 clinical trial?
NCT06589388 is sponsored by Gene Solutions. The principal investigator is Sinh D Nguyen, PhD at Medical Genetics Institude. The trial plans to enroll 100 participants.
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