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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06763289

Acronym

PROFOUND-NPC

Enrollment

700

Registered

2025-01-08

Start date

2024-12-25

Completion date

2027-06-30

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

cell-free DNA, methylation, cancer early detection

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
False positive rate and false negative rate of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the false positive rate and false negative rate among 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.
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	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the sensitivity and specificity among 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.

Secondary

Measure	Time frame	Description
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	2 year	To analyze the early screening detection performance of nasopharyngeal carcinoma in the multi-cancer early screening model, and compare the sensitivity and specificity among 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 in the detection of stage I/II nasopharyngeal carcinoma.
Modeled positive and negative predictive values of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test	2 year	The difference in positive and negative predictive values was calculated combined with the incidence of nasopharyngeal carcinoma and compared among 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.

Countries

China

Outcome results