Clinical Study of Pan-cancer DNA Methylation Test in Plasma

Wuhan Ammunition Life-tech

Status: Enrolling

Conditions: Cancer

Treatments: Diagnostic Test: DNA methylation test

Study type: Observational

Funder types: Industry

Identifiers

NCT05685524

PanCa

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3,000 participants in 2 patient groups

Cancer group

Description:

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.

Treatment:

Diagnostic Test: DNA methylation test

Non-cancer group

Description:

Composed by healthy individuals and patients with non-cancerous diseases including hemorrhoids, enteritis, gastritis, tuberculosis and other non-cancerous diseases.

Treatment:

Diagnostic Test: DNA methylation test