Nasopharyngeal Cancinoma (NPC)NCT06770699
Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Cancinoma (NPC), run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial summary
This study aims to conduct a prospective cohort study to validate the prognostic performance of Tertiary Lymphoid Structures (TLSs) as a predictive marker in pathological tissue sections for nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage II-III Nasopharyngeal Carcinoma
Who may be able to join
- Histopathological confirmed diagnosis of nasopharyngeal carcinoma (NPC).
- No evidence of distant metastasis at initial treatment, with staging classified as II-III (AJCC 9th edition).
- Patients aged 18-75 with a Karnofsky Performance Status (KPS) score ≥ 80.
- Organ Function: Adequate organ function meeting the following criteria:
- Hematology:
- White blood cell count > 3.0 × 10⁹/L. Absolute neutrophil count (ANC) > 1.5 × 10⁹/L. Hemoglobin (Hb) > 90 g/L. Platelet count > 100 × 10⁹/L. Albumin ≥ 3 g/dL.
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- >Liver Function: Bilirubin ≤ 1.5 × the upper limit of normal (ULN); patients with Gilbert's syndrome may enroll if serum bilirubin ≤ 3 × ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; for patients with liver metastasis, AST/ALT ≤ 5 × ULN.
- Alkaline phosphatase (ALP) ≤ 3 × ULN; for patients with liver or bone metastasis, ALP ≤ 5 × ULN.
- >Coagulation Function: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- >Renal Function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min as calculated by the Cockcroft-Gault formula (see Appendix 8).
- Patients willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures.
- Willing to adhere to study arrangements and refrain from participating in any other clinical trials related to drugs or medical devices during the study period.
- Signed a formal informed consent form, indicating that they understand and agree to participate in the study in compliance with hospital policies.
- Sufficient tumor tissue stored in paraffin blocks, suitable for scientific research purposes.
Who cannot join
- Patients with concurrent malignant tumors other than nasopharyngeal carcinoma.
- Patients with a history of severe immediate allergic reactions to any drug used in this study.
- Patients who lack legal capacity or have limited legal capacity.
- Patients with a history of drug or alcohol abuse, or with physical or mental disorders, who, in the investigator's opinion, are unable to fully understand or comply with the study's procedures and potential complications.
- Patients with other serious acute or chronic medical conditions, laboratory abnormalities, or mental disorders that may increase the risk of treatment-related adverse events, interfere with the interpretation of study results, or make them unsuitable for participation in the study, as determined by the investigator. These include, but are not limited to:
- Autoimmune colitis, inflammatory bowel disease, noninfectious pneumonitis, pulmonary fibrosis;
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- Mental disorders such as dementia, epilepsy, or recent (within the past year) or active suicidal ideation or behavior.
- Patients with a prior diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related diseases.
- Pregnant or breastfeeding women, and male or female patients of childbearing potential who are unwilling or unable to use effective contraception throughout the study period and for at least one year after completing the treatment regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Performance of Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma: a Prospective Multi-Center Observational Study
This study aims to conduct a prospective cohort study to validate the prognostic performance of Tertiary Lymphoid Structures (TLSs) as a predictive marker in pathological tissue sections for nasopharyngeal carcinoma (NPC). The TLS assessment framework established in this research has the potential to serve as a reference for personalized treatment strategies in NPC patients.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- nasopharyngeal carcinom, Tertiary Lymphoid Structures, Outcome
- Medical subject headings
- Tertiary Lymphoid Structures
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 |
|---|---|---|
| TLS positive | Positive TLS in Tumor | |
| TLS negative | no TLS in Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
DFS is defined as the time from the date of enrollment to the first occurrence of either disease progression (as confirmed by imaging or clinical evaluation) or death from any cause, whichever occurs first. For patients without these events, DFS is censored at the time of the last follow-up.
Measured: 3 Years
Secondary outcomes (3)
Overall Survival
OS is defined as the time from the date of enrollment to death from any cause, or the time interval to the last follow-up for patients who are alive at the end of the study.
Measured: 3 Years
Locoregional Recurrenc-free Survival
LRRFS is defined as the time from the date of enrollment to the first occurrence of locoregional relapse (confirmed by imaging or clinical evaluation), or the time interval to the last follow-up for patients without locoregional relapse.
Measured: 3 Years
Distant Metastasis-Free Survival
DMFS is defined as the time from the date of enrollment to the first occurrence of distant metastasis (confirmed by imaging or clinical evaluation), or the time interval to the last follow-up for patients without distant metastasis.
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 posted13 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.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies 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
- 260 participants (estimated)
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
- NCT06770699
- Sponsor's protocol ID
- TLS-NPC
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Performance of Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma: a Prospective Multi-Center Observational Study
- ClinicalTrials.gov ID
- NCT06770699
- Acronym / sponsor ID
- TLS-NPC
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- nasopharyngeal carcinom, Tertiary Lymphoid Structures, Outcome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 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
- 13 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.
This study aims to conduct a prospective cohort study to validate the prognostic performance of Tertiary Lymphoid Structures (TLSs) as a predictive marker in pathological tissue sections for nasopharyngeal carcinoma (NPC). The TLS assessment framework established in this research has the potential to serve as a reference for personalized treatment strategies in NPC patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLS positive | – | –Positive TLS in Tumor |
| TLS negative | – | –no TLS in Tumor |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage II-III Nasopharyngeal Carcinoma
Key inclusion criteria (15 listed)
- Histopathological confirmed diagnosis of nasopharyngeal carcinoma (NPC).
- No evidence of distant metastasis at initial treatment, with staging classified as II-III (AJCC 9th edition).
- Patients aged 18-75 with a Karnofsky Performance Status (KPS) score ≥ 80.
- Organ Function: Adequate organ function meeting the following criteria:
- White blood cell count > 3.0 × 10⁹/L. Absolute neutrophil count (ANC) > 1.5 × 10⁹/L. Hemoglobin (Hb) > 90 g/L. Platelet count > 100 × 10⁹/L. Albumin ≥ 3 g/dL.
Key exclusion criteria (9 listed)
- Patients with concurrent malignant tumors other than nasopharyngeal carcinoma.
- Patients with a history of severe immediate allergic reactions to any drug used in this study.
- Patients who lack legal capacity or have limited legal capacity.
- Patients with a history of drug or alcohol abuse, or with physical or mental disorders, who, in the investigator's opinion, are unable to fully understand or comply with the study's procedures and potential complications.
- Patients with other serious acute or chronic medical conditions, laboratory abnormalities, or mental disorders that may increase the risk of treatment-related adverse events, interfere with the interpretation of study results, or make them unsuitable for participation in the study, as determined by the investigator. These include, but are not limited to:
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
Disease-free Survival
Time frame: 3 Years
DFS is defined as the time from the date of enrollment to the first occurrence of either disease progression (as confirmed by imaging or clinical evaluation) or death from any cause, whichever occurs first. For patients without these events, DFS is censored at the time of the last follow-up.
3 secondary outcomes
Overall Survival
Time frame: 3 Years
Locoregional Recurrenc-free Survival
Time frame: 3 Years
Distant Metastasis-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 13 Jan 2025.
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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.
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 Nasopharyngeal Cancinoma (NPC), 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 15 inclusion and 9 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 13 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?
Disease-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?
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 13 Jan 2025; AzTrials last refreshed its copy on 4 Nov 2026.