Carcinoma, Non-Small-Cell LungNARPBLCNCT03724604
NSE/Alb as a Prognostic Biomarker for Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Neuron-Specific Enolase to Albumin Ratio
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First hospital affiliated Xi'an jiaotong university
Xi'an, Shaanxi, 710061
Sida Qin, +8615829916265, sida.qin@yahoo.com
About this study
Official title: A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Neuron-Specific Enolase to Albumin Ratio
- Keywords
- Neuron-Specific Enolase, Albumin, Prognostic Biomarker
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuron-Specific Enolase to Albumin RatioDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| high NAR | Neuron-Specific Enolase to Albumin Ratio is higher than 3.2×10-7 Receives: Diagnostic Test: Neuron-Specific Enolase to Albumin Ratio | |
| low NAR | Neuron-Specific Enolase to Albumin Ratio is lower than 3.2×10-7 Receives: Diagnostic Test: Neuron-Specific Enolase to Albumin Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years.
Secondary outcomes (1)
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.
Measured: 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Jan 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial Cancer Hospital, Shaanxi Provincial People's Hospital, Xi'an Central Hospital
- Responsible party
- Sponsor
- Investigators
- Sida Qin, MD PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724604
- Sponsor's protocol ID
- XJTU1AF-CRF-2017-020
- Acronym
- NARPBLC
- Status last verified
- Aug 2018
- First submitted
- 28 Oct 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on NSE/Alb as a Prognostic Biomarker for Lung Cancer Patients in Multicenter
- ClinicalTrials.gov ID
- NCT03724604
- Acronym / sponsor ID
- NARPBLC / XJTU1AF-CRF-2017-020
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Neuron-Specific Enolase, Albumin, Prognostic Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial Cancer Hospital, Shaanxi Provincial People's Hospital, Xi'an Central Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high NAR | – | Diagnostic Test: Neuron-Specific Enolase to Albumin RatioNeuron-Specific Enolase to Albumin Ratio is higher than 3.2×10-7 |
| low NAR | – | Diagnostic Test: Neuron-Specific Enolase to Albumin RatioNeuron-Specific Enolase to Albumin Ratio is lower than 3.2×10-7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (4 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuron-Specific Enolase to Albumin RatioPrevious 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. | Diagnostic test | high NAR, low NAR |
Primary outcome
Overall survival
Time frame: 2 years.
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.
1 secondary outcome
Disease-free survival
Time frame: 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sida Qin, MD PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sida Qin, MD PhD (+8615829916265, sida.qin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.