Clinical Study of Pan-cancer DNA Methylation Test in Plasma

NCT ID: NCT05685524

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cancer group

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.

DNA methylation test

Intervention Type DIAGNOSTIC_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.

Non-cancer group

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

DNA methylation test

Intervention Type DIAGNOSTIC_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.

Interventions

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DNA 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.

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuhan Ammunition Life-tech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingting Li, PhD

Role: CONTACT

+8613317163670

Facility Contacts

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Dihan Zhou

Role: primary

+86 13871581074

References

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Yang Q, Dong L, Zhang L, Zhang W, Zhang Y, Huang Y, Jin H, Yang H, Liu X, Zhao Y. Analytical and Diagnostic Performance of a Dual-Target Blood Detection Test for Hepatocellular Carcinoma. Cancer Rep (Hoboken). 2024 Sep;7(9):e70017. doi: 10.1002/cnr2.70017.

Reference Type DERIVED
PMID: 39324668 (View on PubMed)

Other Identifiers

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PanCa

Identifier Type: -

Identifier Source: org_study_id

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