Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma
China260 participantsStarted 2025-01-01
Plain-language 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). The TLS assessment framework established in this research has the potential to serve as a reference for personalized treatment strategies in NPC patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
Exclusion criteria
. 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:
. 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.