Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma
1 other identifier
observational
720
1 country
6
Brief Summary
RATIONALE
- 1.In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned.
- 2.Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJune 20, 2018
June 1, 2018
5.3 years
August 5, 2014
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
5-year overall survival
The period until any event (death, local recurrence or distant metastasis) is detected.
5 years after diagnosis
Secondary Outcomes (3)
5-year disease-free survival
5 years after diagnosis
5-year recurrence-free survival
5 years after diagnosis
5-year distant-free survival
5 years after diagnosis
Study Arms (3)
Low Risk Group
Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group.
Intermediate Risk Group
Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group.
High Risk Group
Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group.
Eligibility Criteria
All the participants involved in our study are patients who are first diagnosed nasopharyngeal carcinoma pathologically and treated with radical radiotherapy or chemoradiotherapy in ourhospital from August 1st 2014 to July 31st 2015.
You may qualify if:
- Nasopharyngeal cancer patients diagnosed by pathology or cytology
- UICC/AJCC 2010 Stage T1-4 N0-3 M0
- Male or female patients with age between 18 and 75 years old
- Karnofsky Performance Scores ≥ 60
- Expected survival ≥ 3 months
- Without dysfunction of heart, lung, liver, kidney and hematopoiesis
You may not qualify if:
- Karnofsky Performance Status Score \< 70'
- Radiotherapy uncompleted (≥ 1 fraction missing)
- Distant metastases before or during radiotherapy
- Without weekly complete blood count during radiotherapy
- Application of colony stimulating factor such as erythropoietin
- Signs of infection before radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The Fisrt Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004, China
Anhui Province Hospital
Hefei, Anhui, 230001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000, China
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun-fei Xia, MD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Radiation Oncology, Sun Yat-sen University Cancer Center
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 7, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2024
Last Updated
June 20, 2018
Record last verified: 2018-06