NSE/Alb as a Prognostic Biomarker for Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

— NARPBLC  

Official title:

A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03724604
• Other study ID #: XJTU1AF-CRF-2017-020
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Sida Qin, MD PhD
• Phone: +8615829916265
• Email: sida.qin[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Diagnostic Test:
• Neuron-Specific Enolase to Albumin Ratio
Previous studies have shown that inflammation and nutrition-related factors such as CRP/Alb (C-reactive protein-albumin ratio), PLR (platelet-to-lymphocyte ratio), NLR (neutrophil-to-lymphocyte ratio) can help to assess the prognosis of malignant tumors. This study is the first time to combine NSCLC tumor marker NSE and patient nutrition-related indicators Alb to predict the prognosis of patients, trying to find high sensitivity and specificity for NSCLC prognostic indicators to guide clinical work.

Locations

Country	Name	City	State
China	First hospital affiliated Xi'an jiaotong university	Xi'an	Shaanxi

Sponsors (5)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial Cancer Hospital, Shaanxi Provincial People's Hospital, Xi'an Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The time from randomization to death due to any cause. The last follow-up time is usually calculated as the time of death for those who have been lost before death.	2 years.
Secondary	Disease-free survival	Refers to the time from randomization to relapse or death due to disease progression. It is usually the end point after radical surgery. DFS is more difficult to record as an end point than OS because it requires careful follow-up and timely detection of disease recurrence. In this study, as an important prognostic indicator for patients undergoing NSCLC surgery.	2 years.