Estimating Lymphocyte Counts from DNA Methylation

Completed

• Conditions: Colorectal Cancers; Immunotherapy; DNA Methylation

• Registration Number: NCT06586307
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Response Rate	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.	The complete response rate refers to the percentage of patients who experience a complete disappearance of their disease after treatment.

Trial Locations

Locations (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China