NCT06589388Recruiting
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
ctDNA Monitoring to Predict the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 21 Aug 2024
- Start date
- 21 May 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Gene Solutions
- Diseases
- Colorectal cancer
- NCT number
- NCT06589388
What you commit to
- Study type: Observational
- Planned participants: 100
- From 21 May 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients are indicated for chemoradiation therapy only
Other illness
- Stage I rectal cancer, recurrent or metastatic cancer
- Other cancer metastasis to the rectum
- Have been or are being treated for cancer
Other
- Patients do not agree to participate in the studies.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical Genetics Institute Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.