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NCT06586307Completed

Estimating Lymphocyte Counts from DNA Methylation

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

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?

Status (registry)
Completed
Study type
Observational
Enrollment
49 (actual)
First submitted
2 Sept 2024
Start date
1 Jan 2023
Primary completion date
1 Jul 2024
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
NCT number
NCT06586307

What you commit to

  • Study type: Observational
  • Participants enrolled: 49
  • From 1 Jan 2023 to the primary completion date, 1 Jul 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Patients with concurrent other immune system diseases.

Other

  • The tissue bank does not store the required whole blood or tissue samples for the experiment.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Sixth Affiliate Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.