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Clinical Study of Pan-cancer DNA Methylation Test in Plasma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05685524
Enrollment
3000
Registered
2023-01-17
Start date
2022-07-01
Completion date
2023-12-31
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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

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.

Interventions

DIAGNOSTIC_TESTDNA methylation test

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.

Sponsors

Wuhan Ammunition Life-tech Co., Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivityimmediately after the procedureThe reference standard is the results of histopathological tests
Specificityimmediately after the procedure

Countries

China

Contacts

Primary ContactTingting Li, PhD
litt@whammunition.com+8613317163670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026