Histopathological Diagnosis of Nasopharyngeal CarcinomaNCT06762470
Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma
An observational study of Histopathological Diagnosis of Nasopharyngeal Carcinoma and Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Histopathological Diagnosis of Nasopharyngeal Carcinoma, Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition
- How many people
- 325 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with non-metastatic nasopharyngeal carcinoma
Who may be able to join
- 1.Histopathological diagnosis of nasopharyngeal carcinoma;2.Patients with nasopharyngeal carcinoma without distant metastases after AJCC/UACC 8th edition;3.The radiation therapy technique is IMRT;4.Age 18-70 years;5.Has good organ function;6.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.Willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies.
Who cannot join
- 1.Concomitant with other tumors;2.Those with a history of severe immediate allergies to any of the drugs used in this study;3.Lack of or limited capacity for civil conduct;4.Addiction to drugs or alcohol, with a physical or psychiatric disorder;5.Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease;6.Pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of Pretreatment Peripheral Circulating Lymphocyte CD4/CD8 Ratio in Patients with Non-metastatic Nasopharyngeal Carcinoma: a Multi-center Prospective Observational Study
In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte CD4/CD8 ratio in nasopharyngeal carcinoma patients prior to treatment.
- Conditions
- Histopathological Diagnosis of Nasopharyngeal Carcinoma, Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition
- Keywords
- nasopharyngeal carcinoma, Peripheral blood circulating lymphocytes before treatment, CD4/CD8 ratio, Prognostic value
- Medical subject headings
- Nasopharyngeal Carcinoma
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 |
|---|---|---|
| High CD4/CD8 ratio group | High CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio ≥1 | |
| Low CD4/CD8 ratio group | Low CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio <1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The time from the first diagnosis of nasopharyngeal carcinoma to the first observation of disease progression or death from any cause
Measured: 3 Years
Secondary outcomes (3)
Overall Survival
The time from the first diagnosis of nasopharyngeal carcinoma to the occurrence of death from any cause
Measured: 3 Years
Distant Metastasis-free Survival
Distant metastasis-free survival (DMFS) was defined as the time from diagnosis to the occurrence of distant metastasis or the date of censoring, whichever came first.
Measured: 3 years
Locoregional Recurrenc-free Survival
Locoregional recurrence-free survival (LRRFS) was defined as the time from diagnosis to the occurrence of locoregional recurrence or the date of censoring, whichever came first.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Histopathological Diagnosis of Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- 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
- 325 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762470
- Sponsor's protocol ID
- SKJP1320242038
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tao CJ, Chen YY, Jiang F, Feng XL, Jin QF, Jin T, Piao YF, Chen XZ. A prognostic model combining CD4/CD8 ratio and N stage predicts the risk of distant metastasis for patients with nasopharyngeal carcinoma treated by intensity modulated radiotherapy. Oncotarget. 2016 Jul 19;7(29):46653-46661. doi: 10.18632/oncotarget.9695.
PubMed 27270307Gu Y, Jin Y, Ding J, Yujie W, Shi Q, Qu X, Zhao S, Li J, Lijuan C. Low absolute CD4+ T cell counts in peripheral blood predict poor prognosis in patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Aug;61(8):1869-1876. doi: 10.1080/10428194.2020.1751840. Epub 2020 Apr 23.
PubMed 32324088
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Pretreatment Peripheral Circulating Lymphocyte CD4/CD8 Ratio in Patients with Non-metastatic Nasopharyngeal Carcinoma: a Multi-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06762470
- Acronym / sponsor ID
- SKJP1320242038
- Conditions
- Histopathological Diagnosis of Nasopharyngeal Carcinoma, Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition
- Keywords
- nasopharyngeal carcinoma, Peripheral blood circulating lymphocytes before treatment, CD4/CD8 ratio, Prognostic value
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jan 2025 (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.
In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte CD4/CD8 ratio in nasopharyngeal carcinoma patients prior to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High CD4/CD8 ratio group | – | –High CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio ≥1 |
| Low CD4/CD8 ratio group | – | –Low CD4/CD8 ratio of peripheral blood lymphocytes before treatment: CD4/CD8 ratio <1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-metastatic nasopharyngeal carcinoma
Key inclusion criteria (1 listed)
- 1.Histopathological diagnosis of nasopharyngeal carcinoma;2.Patients with nasopharyngeal carcinoma without distant metastases after AJCC/UACC 8th edition;3.The radiation therapy technique is IMRT;4.Age 18-70 years;5.Has good organ function;6.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.Willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies.
Key exclusion criteria (1 listed)
- 1.Concomitant with other tumors;2.Those with a history of severe immediate allergies to any of the drugs used in this study;3.Lack of or limited capacity for civil conduct;4.Addiction to drugs or alcohol, with a physical or psychiatric disorder;5.Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease;6.Pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.
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
Progression Free Survival
Time frame: 3 Years
The time from the first diagnosis of nasopharyngeal carcinoma to the first observation of disease progression or death from any cause
3 secondary outcomes
Overall Survival
Time frame: 3 Years
Distant Metastasis-free Survival
Time frame: 3 years
Locoregional Recurrenc-free Survival
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 27270307Tao CJ, Chen YY, Jiang F, Feng XL, Jin QF, Jin T, Piao YF, Chen XZ. A prognostic model combining CD4/CD8 ratio and N stage predicts the risk of distant metastasis for patients with nasopharyngeal carcinoma treated by intensity modulated radiotherapy. Oncotarget. 2016 Jul 19;7(29):46653-46661. doi: 10.18632/oncotarget.9695.
- Background: PubMed 32324088Gu Y, Jin Y, Ding J, Yujie W, Shi Q, Qu X, Zhao S, Li J, Lijuan C. Low absolute CD4+ T cell counts in peripheral blood predict poor prognosis in patients with newly diagnosed multiple myeloma. Leuk Lymphoma. 2020 Aug;61(8):1869-1876. doi: 10.1080/10428194.2020.1751840. Epub 2020 Apr 23.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Histopathological Diagnosis of Nasopharyngeal Carcinoma and Patients with Nasopharyngeal Carcinoma Without Distant Metastases After AJCC/UACC 8th Edition, run by Jiangxi Provincial Cancer Hospital 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762470, which also lists 2 linked publications.
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 9 Jan 2025.