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NCT06763289

Comparison of Multi-omics Models for Early Nasopharyngeal Carcinoma Screening: CfDNA Methylation, EBV DNA, and Serological Double-antibodies Detection

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

This study focus on nasopharyngeal carcinoma, a cancer type with Chinese characteristics, analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the performance differences among multi-omics models such as nasopharyngeal carcinoma-specific DNA methylation and fragmentome in the multi-cancer early screening model and the clinically routinely conducted Epstein-Barr virus (EBV) nucleic acid quantification (EBV DNA) test and serological double antibody (double antibodies of EBNA1-IgA and VCA-IgA) test. It suggests that compared with EBV DNA quantification and double antibody tests, in patients with nasopharyngeal carcinoma, multi-omics models such as DNA methylation can avoid false negatives, improve sensitivity, and increase the detection rate of early-stage nasopharyngeal carcinoma; in patients without nasopharyngeal carcinoma, multi-omics models such as DNA methylation can avoid false positives, improve specificity, and avoid unnecessary over-diagnosis.

Official title: Comparison Between Multi-omics Models Including DNA Methylation in CfDNA, Quantitative Determination of Epstein-Barr Virus Nucleic Acid and Serological Double Antibody Detection in Early Screening of Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

700

Start Date

2024-12-25

Completion Date

2027-06-30

Last Updated

2025-01-08

Healthy Volunteers

Yes

Conditions

Nasopharyngeal Carcinoma (NPC)

Inclusion Criteria for Case Arm Participants: 1. 40-74 years old 2. Clinically and/or pathologically diagnosed cancer 3. No prior or undergoing any systemic or local antitumor therapy, including but not limited to surgical resection, radiochemotherapy, endocrinotherapy, targeted therapy, immunotherapy, interventional therapy, etc. 4. Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Case Arm Participants: 1. Pregnancy or lactating women 2. Known prior or current diagnosis of other types of malignancies comorbidities 3. Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen 4. Recipients of organ transplant or prior bone marrow transplant or stem cell transplant 5. Recipients of blood transfusion within 30 days prior to screen 6. Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide 7. Unsuitable for this trial determined by the researchers Inclusion Criteria for Control Arm Participants: 1. 40-74 years old 2. Without confirmed cancer diagnosis 3. Able to provide a written informed consent and willing to comply with all part of the protocol procedures Exclusion Criteria for Control Arm Participants: 1. Pregnancy or lactating women 2. Known prior or current diagnosis of other types of malignancies comorbidities 3. Severe acute infection (e.g. severe or critical COVID-19, sepsis, etc.) or febrile illness (body temperature of ≥ 38.5 °C) within 14 days prior to screen 4. Recipients of organ transplant or prior bone marrow transplant or stem cell transplant 5. Recipients of blood transfusion within 30 days prior to screen 6. Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide 7. Unsuitable for this trial determined by the researchers

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China