Clinical trial NCT06762470: Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma
Official title: Prognostic Value of Pretreatment Peripheral Circulating Lymphocyte CD4/CD8 Ratio in Patients with Non-metastatic Nasopharyngeal Carcinoma: a Multi-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Histopathological Diagnosis of Nasopharyngeal Carcinoma
Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition
Keywords: nasopharyngeal carcinoma
Peripheral blood circulating lymphocytes before treatment
CD4/CD8 ratio
Prognostic value
Lead sponsor: Jiangxi Provincial Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-metastatic nasopharyngeal carcinoma

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 3 Years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 Years
measure: Distant Metastasis-free Survival
timeFrame: 3 years
measure: Locoregional Recurrenc-free Survival
timeFrame: 3 Years
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
Study officials:
References:
citation: Tao CJ, Chen YY, Jiang F, Feng XL, Jin QF, Jin T, Piao YF, Chen XZ. A prognostic model combining CD4/CD8 ratio and N stage predicts the risk of distant metastasis for patients with nasopharyngeal carcinoma treated by intensity modulated radiotherapy. Oncotarget. 2016 Jul 19;7(29):46653-46661. doi: 10.18632/oncotarget.9695.
citation: Gu Y, Jin Y, Ding J, Yujie W, Shi Q, Qu X, Zhao S, Li J, Lijuan C. Low absolute CD4+ T cell counts in peripheral blood predict poor prognosis in patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Aug;61(8):1869-1876. doi: 10.1080/10428194.2020.1751840. Epub 2020 Apr 23.