Estimating Lymphocyte Counts from DNA Methylation

NCT ID: NCT06586307

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-01

Brief Summary

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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

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Conditions

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Colorectal Cancers Immunotherapy DNA Methylation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yanxin Luo,MD

Head of Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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MeTIL-01

Identifier Type: -

Identifier Source: org_study_id

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