Clinical Study of Pan-cancer DNA Methylation Test in Plasma

Trial Title: Clinical Study of Pan-cancer DNA Methylation Test in Plasma

NCT ID: NCT05685524

Condition: Cancer

Conditions: Keywords:
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

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Diagnostic Test
Intervention name: DNA methylation test
Description: 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.
Arm group label: Cancer group
Arm group label: Non-cancer group

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.

Criteria for eligibility:

Study pop:
200 cases are planned for each cancer type, and the total number of samples in the cancer group is expected to be 2,000.The number of samples in the non-cancer group is expected to be 1000 cases。

Sampling method: Probability Sample
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The first affiliated hospital of Zhengzhou University

Address:
City: Zhengzhou
Zip: 450000
Country: China

Status: Recruiting

Contact:
Last name: Dihan Zhou

Phone: +86 13871581074
Email: words1846@hotmail.com

Investigator:
Last name: Yanteng Zhao, PhD
Email: Principal Investigator

Start date: July 1, 2022

Completion date: December 2023

Lead sponsor:
Agency: Wuhan Ammunition Life-tech Co., Ltd
Agency class: Industry

Source: Wuhan Ammunition Life-tech Co., Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05685524