NCT05685524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

January 5, 2023

Last Update Submit

January 5, 2023

Conditions

Cancer

Keywords

Colorectal cancerLiver cancerSquamous cell carcinoma of the head and neckEsophageal carcinomaPancreatic cancerOvarian cancerBladder cancerCervical cancerLung cancerStomach cancer

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    The reference standard is the results of histopathological tests

    immediately after the procedure

  • Specificity

    immediately after the procedure

Study Arms (2)

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.

Diagnostic Test: DNA methylation test

Non-cancer group

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

Diagnostic Test: DNA methylation test

Interventions

DNA methylation testDIAGNOSTIC_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.

Cancer groupNon-cancer group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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。

You may qualify if:

  • \- (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39324668DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

NeoplasmsColorectal NeoplasmsLiver NeoplasmsSquamous Cell Carcinoma of Head and NeckEsophageal NeoplasmsPancreatic NeoplasmsOvarian NeoplasmsUrinary Bladder NeoplasmsUterine Cervical NeoplasmsLung NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHead and Neck NeoplasmsEsophageal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersUrologic NeoplasmsUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesStomach Diseases

Central Study Contacts

Tingting Li, PhD

CONTACT

+8613317163670litt@whammunition.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

July 1, 2022

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)