Comparing methods for early detection of nasopharyngeal carcinoma

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

This study is testing new ways to detect nasopharyngeal cancer early to see if they work better than the current methods.

Quick facts

• Study type: Observational
• Enrollment: 700 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University (other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06763289 on ClinicalTrials.gov

What this trial studies

This study focuses on nasopharyngeal carcinoma (NPC), a cancer prevalent in certain populations, and evaluates the effectiveness of various multi-omics models for early detection. It compares the performance of nasopharyngeal carcinoma-specific DNA methylation and fragmentome analysis against traditional methods like Epstein-Barr virus (EBV) DNA quantification and serological double-antibody tests. The goal is to enhance sensitivity and specificity in detecting early-stage NPC, potentially reducing false negatives and positives. Participants will be monitored to assess the accuracy of these detection methods.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-74 who have been clinically or pathologically diagnosed with nasopharyngeal carcinoma and have not received any prior cancer treatment.

Not a fit: Patients with other malignancies, severe infections, or those who have recently undergone certain medical treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate early detection of nasopharyngeal carcinoma, improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using multi-omics approaches for cancer detection, suggesting potential success for this novel approach.

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

Where this trial is running

Guangzhou, Guangdong

• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: WeiPing Wen

Conditions: Nasopharyngeal Carcinoma, cell-free DNA, methylation, cancer early detection