Clinical trial NCT06763289: Comparison of Multi-omics Models for Early Nasopharyngeal Carcinoma Screening: CfDNA Methylation, EBV DNA, and Serological Double-antibodies Detection
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasopharyngeal Carcinoma (NPC)
Keywords: cell-free DNA
methylation
cancer early detection
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Fujian Medical University
name: Hainan People's Hospital
name: Xiangya Hospital of Central South University
name: First People's Hospital of Foshan
name: Zhongshan People's Hospital, Guangdong, China
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: People's Hospital of Guangxi Zhuang Autonomous Region
First posted: 2025-01-08
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed cancers or individuals without confirmed cancer will be invited to participate in this case-control study by a designated consenting professional.

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.


Eligibility criteria: 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

Primary outcomes:
measure: False positive rate and false negative rate of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test
timeFrame: 2 year
measure: 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
timeFrame: 2 year
Secondary outcomes:
measure: 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
timeFrame: 2 year
measure: Modeled positive and negative predictive values of ctDNA Methylation model, EBV DNA quantification test, double antibodies of EBNA1-IgA and VCA-IgA test
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: