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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Viet Nam
Medical Genetics Institute
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Lan NL Tu, PhD
lantu@genesolutions.vn
+84888843489
Backup
Van T Phan, MSc
vanphan@genesolutions.vn
+84908145990
Time Frame
Start Date: 2024-05-21
Estimated Completion Date: 2027-12
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: Gene Solutions

This content was sourced from clinicaltrials.gov