Clinical Study of Pan-cancer DNA Methylation Test in Plasma

Study Overview
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Brief Summary
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We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.

Official Title
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Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers

Conditions
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Cancer

Intervention / Treatment
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* Diagnostic Test: DNA methylation test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - (1)age >= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc. (3) no treatment with radiotherapy or chemotherapy. Exclusion Criteria: (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer group<br>Patients aged 18 years or older with high suspicion of cancer diagnosed by endoscopy, other imaging tests, pathological examinations, etc. The cancer types include liver cancer, head and neck squamous cell carcinoma, esophageal cancer, pancreatic cancer, ovarian cancer, colorectal cancer, bladder cancer, cervical cancer, lung cancer and stomach cancer. | Diagnostic Test: DNA methylation test<br>* Cell-free DNA were extracted from plasma collected from individuals of cancer and non-cancerous disease groups, then the DNA was bisulfite converted and tested by DNA methylation assay based on real-time PCR platform.<br>|
| Non-cancer group<br>Composed by healthy individuals and patients with non-cancerous diseases including hemorrhoids, enteritis, gastritis, tuberculosis and other non-cancerous diseases. | Diagnostic Test: DNA methylation test<br>* Cell-free DNA were extracted from plasma collected from individuals of cancer and non-cancerous disease groups, then the DNA was bisulfite converted and tested by DNA methylation assay based on real-time PCR platform.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The reference standard is the results of histopathological tests | immediately after the procedure | 
| Specificity |  | immediately after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Liver cancer, Squamous cell carcinoma of the head and neck, Esophageal carcinoma, Pancreatic cancer, Ovarian cancer, Bladder cancer, Cervical cancer, Lung cancer, Stomach cancer