Clinical trial NCT03724604: NSE/Alb as a Prognostic Biomarker for Lung Cancer
Official title: A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Neuron-Specific Enolase
Albumin
Prognostic Biomarker
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Shanxi Provincial Cancer Hospital
name: Shaanxi Provincial People's Hospital
name: Xi'an Central Hospital
First posted: 2018-10-30
Enrollment: 202
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: Sample sources: Xi'an Jiaotong University First Affiliated Hospital, Second Affiliated Hospital, Shaanxi Provincial People's Hospital, Shaanxi Provincial Cancer Hospital and other hospitals.

Subject recruitment process:

1. Subject screening: Subjects were screened according to inclusion and exclusion criteria.
2. Recruitment of the research subject: In the course of clinical diagnosis and treatment, the competent doctor recruits.
3. Subject informed consent: inform patients to collect their clinical data and follow up for clinical studies, signing informed consent.

Brief summary: The incidence and mortality rate of lung cancer is the highest in the world. Current studies have found that tumor markers, inflammatory or nutritional indicators have a good predictive value for the prognosis of patients with non-small cell lung cancer (NSCLC). Neuron specific enolase (NSE) and serum albumin (Alb) are important indicators for monitoring tumor progression and nutritional status in lung cancer patients, respectively. Previous studies suggested that the higher the NSE, the worse prognosis of NSCLC patients, while the lower the Alb, the worse the prognosis of patients with malignant tumors. Through a retrospective study, the investigators found that NAR (NSE Alb Ratio) was higher and prognosis was poorer in patients undergoing NSCLC surgery. This is better than the previous assessment indicators PLR (platelet to lymphocyte ratio), NLR (neutrophil to lymphocyte ratio), AGR (albumin to globulin ratio), NAR can better assess prognosis. Therefore, on the basis of the previous retrospective analysis, the optimal NAR cut-off value was calculated according to ROC curve, and the value was grouped into multi-center prospective cohort study, and the relationship between NAR and other clinical indicators was studied by chi-square test. Univariate and multivariate analysis of Cox proportional hazard regression model was used to determine the prognostic factors. Finally, NSCLC patients were stratified according to tumor stage and pathological classification, and the differences of survival time between high NAR group and low NAR group were compared again under different stages and types, and the different stages of NAR in NSCLC patients were further analyzed. The clinical significance of typing. By exploring and validating the relationship between NAR and the prognosis of NSCLC patients, the investigators try to establish a new prognostic index. Obviously, it has important value for clinical application.


Eligibility criteria: Inclusion Criteria:

* (1) pathological diagnosis of non-small cell lung cancer
* (2) 18-70 years of age and no gender restriction.
* (3) patients who were admitted for the first time and underwent routine blood tests, three lung cancer and liver function tests.

Exclusion Criteria:

* (1) pregnant or lactating women
* (2) patients with other malignancies at the same time
* (3) patients with acute and chronic inflammation, autoimmune diseases, and patients with obvious liver and renal insufficiency.
* (4) patients with incomplete clinical and pathological data.

Primary outcomes:
measure: Overall survival
timeFrame: 2 years.
Secondary outcomes:
measure: Disease-free survival
timeFrame: 2 years.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First hospital affiliated Xi'an jiaotong university
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Sida Qin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: