Clinical Study of Pan-cancer DNA Methylation Test in Plasma

Recruiting

• Conditions: Cancer
• Interventions: Diagnostic Test: DNA methylation test

• Registration Number: NCT05685524
• Lead Sponsor: Wuhan Ammunition Life-tech Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Last Update Submitted: 2023-01-05
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-cancer group	DNA methylation test	Composed by healthy individuals and patients with non-cancerous diseases including hemorrhoids, enteritis, gastritis, tuberculosis and other non-cancerous diseases.
Cancer group	DNA methylation test	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity	immediately after the procedure	The reference standard is the results of histopathological tests
Specificity	immediately after the procedure

Trial Locations

Locations (1)

The first affiliated hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China