RecruitingNCT06589388

ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer

ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer

Sponsor

Gene Solutions

Enrollment

100 participants

Start Date

May 21, 2024

Study Type

OBSERVATIONAL

Conditions

Rectal Cancer Rectal Cancer Stage II Rectal Cancer Stage III

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether measuring cancer DNA fragments in the blood (called ctDNA) can predict how well rectal cancer responds to a treatment approach called total neoadjuvant therapy (TNT), which combines chemotherapy and radiation before surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with stage II or III rectal cancer - You are scheduled to receive total neoadjuvant therapy (combined chemo and radiation before surgery) - A preserved biopsy tissue sample is available from your diagnosis **You may NOT be eligible if...** - You have stage I rectal cancer, or cancer that has come back or spread to other organs - Your rectal cancer is actually a metastasis from another primary cancer - You are only scheduled for chemoradiation alone (not the full TNT approach) - You are currently being treated for another cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Locations(1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06589388

Related Trials

Neoadjuvant Radiotherapy for Rectal Adenocarcinoma With Capecitabine Versus TAS-102 (Neo-REACT): A Multi-center, Randomized, Phase III Trial

NCT068500901 location

Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

NCT075610601 location

Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer

NCT075282091 location

Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer

NCT046430411 location

Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients

NCT031909411 location