NSE/Alb as a Prognostic Biomarker for Lung Cancer

NCT ID: NCT03724604

Last Updated: 2019-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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high NAR

Neuron-Specific Enolase to Albumin Ratio is higher than 3.2×10-7

Neuron-Specific Enolase to Albumin Ratio

Intervention Type DIAGNOSTIC_TEST

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.

low NAR

Neuron-Specific Enolase to Albumin Ratio is lower than 3.2×10-7

Neuron-Specific Enolase to Albumin Ratio

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Shaanxi Provincial Cancer Hospital

OTHER

Sponsor Role collaborator

Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xi'an Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sida Qin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First hospital affiliated Xi'an jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Sida Qin, MD PhD

Role: CONTACT

+8615829916265

Facility Contacts

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Sida Qin

Role: primary

+8615829916265

Other Identifiers

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XJTU1AF-CRF-2017-020

Identifier Type: -

Identifier Source: org_study_id

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