Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT06787456
Brief Summary:
The purpose of this study is to establish a comprehensive and integrated nasopharyngeal carcinoma screening cohort, which includes an epidemiological information database containing basic information, gender, age, ethnic and family history, dietary and lifestyle habits, and geographical environmental factors; a biobank of blood, tissue fluid, swabs, etc., for Epstein-Barr virus, tumors, and genetics; a clinical examination database including nasopharyngoscopy, imaging, pathology, and other examinations; and databases of Epstein-Barr virus and human genetic sequencing, etc.
Detailed Description:
This study aims to initiate a multicenter prospective nasopharyngeal carcinoma (NPC) screening cohort study around China, starting from regions with high incidence of NPC, to conduct a million-person-scale screening cohort study. Participants who meet the selection criteria will be included in the cohort. All participants will undergo an epidemiological information survey (including basic conditions, dietary and lifestyle habits, social, geographical, environmental, and other information) through questionnaires, and various samples such as blood, tissue fluid, and throat swabs will be collected. Quantitative testing or genetic sequencing will be conducted on Epstein-Barr virus (EBV) (including EBV-related proteins, antibodies, EBV DNA quantification and sequence length, methylation levels, and next-generation sequencing), nasopharyngeal epithelial or tumor cells, etc., to establish, validate, optimize, and promote the optimal combination screening strategy for NPC; participants defined as high-risk of NPC by screening will undergo clinical nasopharyngoscopy and combined imaging and pathological examinations to confirm NPC patients and provide them with precise clinical treatment; regular follow-ups of the entire cohort will be conducted to study the risk factors and molecular mechanisms of NPC. The purpose of this study is to establish a comprehensive and integrated data platform, primarily based on the population from the South China, including an NPC epidemiological information database based on the gender, age, ethnicity, dietary and lifestyle habits, and geographical environmental factors, a biobank based on various samples and screening test results, and a clinical examination database based on nasopharyngoscopy, head and neck MRI, and a database for EB virus and human genetic sequencing information, etc., forming a multi-source heterogeneous, open, and shared data platform. Based on this data platform, basic scientific and clinical research on NPC will be conducted, including: developing, validating, and optimizing new NPC screening markers and their composite screening programs, clarifying the target population for the promotion of NPC composite screening programs; research study of the etiology and risk factors of NPC from genetic, ethnic, geographical, environmental, and lifestyle aspects, proposing a dynamic evolutionary molecular theory of NPC occurrence and development; exploring NPC prevention measures through lifestyle changes, vaccination interventions, and other methods; exploring new de-escalation clinical treatment plans for NPC, constructing new strategies for precise prevention and treatment of NPC such as minimally invasive surgical treatment and de-escalation of chemoradiotherapy, etc.
Study:
NCT06787456
Study Brief:
Protocol Section:
NCT06787456