Clinical trial · Observational
Estimating Lymphocyte Counts from DNA Methylation
Assessment of DNA Methylation Signatures in Lymphocytes for Evaluating the Efficacy and Prognosis of Immunotherapy in Colorectal Cancer
NCT06586307CI-TRIAL-00080695completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to assess lymphocyte levels in colorectal cancer patients using DNA methylation levels in tissues or blood. The main questions it aims to answer are: Can DNA methylation features calculate lymphocyte levels? Can the calculated lymphocyte levels assess the efficacy and prognosis of immunotherapy?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancers | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| DNA Methylation | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quantitative analysis of DNA methylation at single-base resolution (QASM) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- From the date of neoadjuvant therapy until the date when the surgical specimen pathology results are obtained, the duration of neoadjuvant therapy is approximately half a year, with a maximum of one year.
- description
- The complete response rate refers to the percentage of patients who experience a complete disappearance of their disease after treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with colorectal cancer by colonoscopy pathology and deemed eligible for immunotherapy after assessment. 2. Neoadjuvant immunotherapy regimen includes PD-1 or anti-PD-L1. 3. R0 resection is performed after neoadjuvant immunotherapy. 4. Complete immunotherapy efficacy assessment data and follow-up data are available. 5. The tissue bank stores the required whole blood and tissue samples for the experiment. Exclusion Criteria: 1. Concurrent other malignancies. 2. Neoadjuvant immunotherapy not conducted according to the standard protocol. 3. Severe adverse chemotherapy reactions that lead to the discontinuation of immunotherapy midway. 4. Lack of complete neoadjuvant chemotherapy efficacy assessment data or follow-up data. 5. The tissue bank does not store the required whole blood or tissue samples for the experiment. 6. Patients with concurrent other immune system diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.