Estimating Lymphocyte Counts from DNA Methylation

NCT06586307 | Completed

• 1 other identifier: MeTIL-01
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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?

Conditions

Colorectal Cancers; Immunotherapy; DNA Methylation

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The complete response rate refers to the percentage of patients who experience a complete disappearance of their disease after treatment.

  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.

Interventions

quantitative analysis of DNA methylation at single-base resolution (QASM) OTHER

qPCR-based quantitative analysis for single-base methylation (QASM) The methylation percentage of each candidate CpG site was determined in multiple cohorts using a MethyLight-based QASM assay that has been developed and validated in our previous work. In short, the bisulfite-converted DNA was amplified, in which we exploited the locus-specific PCR primers flanking a pair of methylated and unmethylated probes labeled with the fluorescent dyes 6-carboxyfluorescein (6-FAM) and 2-chloro-7phenyl-1,4-dichloro-6-carboxyfluorescein (VIC), respectively. The methylation percentage was calculated by methylation/(methylation+unmethylation)×100%. QASM was performed using the Applied Biosystems QuantStudio 7 Flex Real-Time PCR System (Thermo).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

we prospectively enrolled 49 patients with advanced-stage CRC who received neoadjuvant immunotherapy as part of their treatment regimens at the Sixth Affiliated Hospital, Sun Yat-sen University from January 2022 to June 2024.

You may qualify if:

• Diagnosed with colorectal cancer by colonoscopy pathology and deemed eligible for immunotherapy after assessment.
• Neoadjuvant immunotherapy regimen includes PD-1 or anti-PD-L1.
• R0 resection is performed after neoadjuvant immunotherapy.
• Complete immunotherapy efficacy assessment data and follow-up data are available.
• The tissue bank stores the required whole blood and tissue samples for the experiment.

You may not qualify if:

• Concurrent other malignancies.
• Neoadjuvant immunotherapy not conducted according to the standard protocol.
• Severe adverse chemotherapy reactions that lead to the discontinuation of immunotherapy midway.
• Lack of complete neoadjuvant chemotherapy efficacy assessment data or follow-up data.
• The tissue bank does not store the required whole blood or tissue samples for the experiment.
• Patients with concurrent other immune system diseases.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)