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
| Registry | NCT06763289, acronym PROFOUND-NPC |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 700 (Estimated) |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University (Other); collaborators: First Affiliated Hospital of Fujian Medical University, Hainan People's Hospital, Xiangya Hospital of Central South University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Sixth Affiliated Hospital, Sun Yat-sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, People's Hospital of Guangxi Zhuang Autonomous Region |
| Conditions | Nasopharyngeal Carcinoma (NPC) |
| Dates | start 2024-12-25, primary completion 2026-12-31 (estimated), completion 2027-06-30 (estimated), first posted 2025-01-08, last updated 2026-09-02 |
| Locations | 1 site in China |
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All trials for Nasopharyngeal Carcinoma (NPC)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Case arm | Participants with newly diagnosed cancer of nasopharyngeal carcinoma | ||
| Control arm | Participants without a cancer diagnosis after routine cancer screening tests. |
Sex: All, ages: 40 Years to 75 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong | China |