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

Официальное название

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

Обзор

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.

Первичные конечные точки

• False positive rate and false negative rate of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test [Срок оценки: 2 year]
• Sensitivity and specificity of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test in the Screening of nasopharyngeal carcinoma [Срок оценки: 2 year]

Вторичные конечные точки (2)

• Sensitivity and specificity of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test in the detection of early-stage nasopharyngeal carcinoma [Срок оценки: 2 year]
• Modeled positive and negative predictive values of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test [Срок оценки: 2 year]

Критерии участия

Inclusion Criteria for Case Arm Participants:

• 40-74 years old
• Clinically and/or pathologically diagnosed cancer
• 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.
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria for Case Arm Participants:

• Pregnancy or lactating women
• Known prior or current diagnosis of other types of malignancies comorbidities
• 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
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to screen
• Recipients of therapy in past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
• Unsuitable for this trial determined by the researchers

Inclusion Criteria for Control Arm Participants:

• 40-74 years old
• Without confirmed cancer diagnosis
• Able to provide a written informed consent and willing to comply with all part of the protocol procedures

Exclusion Criteria for Control Arm Participants:

• Pregnancy or lactating women
• Known prior or current diagnosis of other types of malignancies comorbidities
• 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
• Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
• Recipients of blood transfusion within 30 days prior to screen
• Recipients of therapy in the past 14 days prior to screen, including oral or IV antibiotics, glucocorticoid, azacitidine, decitabine, procainamide, hydrazine, arsenic trioxide
• Unsuitable for this trial determined by the researchers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06763289 · PROFOUND-NPC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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