Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma

January 8, 2025 updated by: Jiangxi Provincial Cancer Hospital

Prognostic Value of Pretreatment Peripheral Circulating Lymphocyte CD4/CD8 Ratio in Patients with Non-metastatic Nasopharyngeal Carcinoma: a Multi-center Prospective Observational Study

In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte CD4/CD8 ratio in nasopharyngeal carcinoma patients prior to treatment.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with non-metastatic nasopharyngeal carcinoma

Description

Inclusion Criteria:

  • 1.Histopathological diagnosis of nasopharyngeal carcinoma;2.Patients with nasopharyngeal carcinoma without distant metastases after AJCC/UACC 8th edition;3.The radiation therapy technique is IMRT;4.Age 18-70 years;5.Has good organ function;6.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.Willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies.

Exclusion Criteria:

  • 1.Concomitant with other tumors;2.Those with a history of severe immediate allergies to any of the drugs used in this study;3.Lack of or limited capacity for civil conduct;4.Addiction to drugs or alcohol, with a physical or psychiatric disorder;5.Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease;6.Pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High CD4/CD8 ratio group
High CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio ≥1
Low CD4/CD8 ratio group
Low CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio <1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 3 Years
The time from the first diagnosis of nasopharyngeal carcinoma to the first observation of disease progression or death from any cause
3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 Years
The time from the first diagnosis of nasopharyngeal carcinoma to the occurrence of death from any cause
3 Years
Distant Metastasis-free Survival
Time Frame: 3 years
Distant metastasis-free survival (DMFS) was defined as the time from diagnosis to the occurrence of distant metastasis or the date of censoring, whichever came first.
3 years
Locoregional Recurrenc-free Survival
Time Frame: 3 Years
Locoregional recurrence-free survival (LRRFS) was defined as the time from diagnosis to the occurrence of locoregional recurrence or the date of censoring, whichever came first.
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Provincial Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKJP1320242038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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