Nasopharyngeal NeoplasmsNCT02211677
Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Neoplasms and Blood Cell Count, run by Sun Yat-sen University at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Neoplasms, Blood Cell Count, Neoplasm Staging
- How many people
- 720 participants
- Where
- 6 sitesChina
- Study dates
- Aug 2014to Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 1 recruiting
- Suspended
The Fisrt Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yun-fei Xia, MD, +8618665031162, xiayf@sysucc.org.cn
Yun-fei Xia, MD
- Suspended
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
- Suspended
Anhui Province Hospital
Hefei, Anhui, 230001
- Suspended
The Affiliated Hospital of Luzhou Medical College
Luzhou, Sichuan, 646000
- Suspended
The Central Hospital of Shaoyang
Shaoyang, Hunan, 422000
About this study
Official title: Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study
RATIONALE
- 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.
- Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.
PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.
Read the detailed description
Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
The period until any event (death, local recurrence or distant metastasis) is detected.
Measured: 5 years after diagnosis
Secondary outcomes (3)
5-year disease-free survival
The period until local recurrence or distant metastasis is detected.
Measured: 5 years after diagnosis
5-year recurrence-free survival
The period until local recurrence is detected.
Measured: 5 years after diagnosis
5-year distant-free survival
The period until distant metastasis is detected.
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-fei Xia, Sun Yat-sen University
- Investigators
- Yun-fei Xia, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211677
- Sponsor's protocol ID
- B2014-002-01
- Status last verified
- Jun 2018
- First submitted
- 5 Aug 2014
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study
- ClinicalTrials.gov ID
- NCT02211677
- Acronym / sponsor ID
- B2014-002-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- 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.
RATIONALE
- 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.
- Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.
PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.
Detailed description
Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
5-year overall survival
Time frame: 5 years after diagnosis
The period until any event (death, local recurrence or distant metastasis) is detected.
3 secondary outcomes
5-year disease-free survival
Time frame: 5 years after diagnosis
5-year recurrence-free survival
Time frame: 5 years after diagnosis
5-year distant-free survival
Time frame: 5 years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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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.
Yun-fei Xia, MD principal investigator
Sun Yat-Sen University Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Neoplasms and Blood Cell Count, run by Sun Yat-sen University at 6 sites 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 6 inclusion and 6 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Yun-fei Xia, MD (+8618665031162, xiayf@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 years after diagnosis). 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 20 Jun 2018.