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Completed

NCT Number: NCT06586307

Estimating Lymphocyte Counts from DNA Methylation

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?

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Key information

Conditions

Colorectal Cancers Colonic Diseases Colorectal Neoplasms DNA Methylation Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Immunotherapy Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Sixth Affiliate Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Primary outcomes

  1. Complete Response Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Assessment of DNA Methylation Signatures in Lymphocytes for Evaluating the Efficacy and Prognosis of Immunotherapy in Colorectal Cancer

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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