ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGene Solutions
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of patients aged 18 years and older, diagnosed with stage II-III rectal cancer, and indicated for total neoadjuvant chemotherapy. Participants must meet all inclusion criteria and no exclusion criteria. Recruitment will take place at 175 Military Hospital, Nguyen Tri Phuong Hospital, and 108 Military Center Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To investigate the detection rate and change of ctDNA in blood samples of rectal cancer patients during total neoadjuvant therapy
Determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after total neoadjuvant therapy and assess changes in ctDNA expression within the study population during treatment. * Determine the ctDNA positivity rate before treatment. * Determine the ctDNA positivity rate during total neoadjuvant therapy TNT. * Determine the ctDNA positivity rate after TNT and assess ctDNA level changes during treatment.
Time frame
12 months2
To investigate the relationship between ctDNA expression and MRI/CT scan imaging with pCR response in total neoadjuvant therapy (TNT)
* To investigate the prediction value of ctDNA to pathological complete response (pCR) in TNT: Calculate the percentage PPV, NPV of ctDNA to pCR * To investigate the prediction value of MRI/CT results to pCR in TNT: Calculate the percentage PPV, NPV of MRI/CT scan (RECIST 1.1) to pCR * To investigate the prediction value of MRI/CT results combined ctDNA results to pCR in TNT: Calculate the percentage PPV, NPV of MRI/CT combined ctDNA to pCR
Time frame
6 months3
Evaluate the relationship between post-TNT ctDNA expression and disease-free survival in colorectal cancer patients in 2 years
Create a Kaplan-Meier curve to estimate the disease-free survival of two years according to the after-treatment ctDNA status of patients.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov