This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05668910
Recruitment Status : Recruiting
First Posted : December 30, 2022
Last Update Posted : December 30, 2022
Sponsor:
Collaborator:
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Information provided by (Responsible Party):
GeneCast Biotechnology Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To facilitate the early gastric cancer diagnosis, an assay based on assessing large-scale methylation and fragmentation profiles of the plasma cell free (cfDNA) will be developed and validated.

Condition or disease Intervention/treatment
Gastric Cancer Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA

Detailed Description:

Cancer-related features in cell-free DNA (cfDNA) fragments have gradually been identified and play essential roles for non-invasive early cancer detection. Integrated analysis of several cfDNA features have proven to achieve enhanced detection sensitivity as compared to single feature.

This study aims to develop and validate a novel blood-based whole methylome sequencing followed with a multi-dimensional model to analyze several features of cfDNA for GC early detection. Specifically, blood samples will be prospectively collected before gastroscopy. Cases and controls will be randomly divided into a training and a testing dataset at a ratio of 2:1. Plasma cfDNA will be isolated and extracted, followed with a bisulfite-free low-depth whole methylome sequencing. A multi-dimensional model named THorough Epigenetic Marker Integration Solution (THEMIS) including methylation, fragmentation, and chromosomal copy number alternation will be constructed in the training dataset. The performance of the model in differentiating cancer patients from non-cancer controls will then be evaluated in the testing dataset.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Development and Validation of a Blood-based Assay for Gastric Cancer Early Detection Using Multi-dimensional Analysis of Cell Free DNA Whole Methylome Sequencing-Protocol for an Observational, Case-control Study
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
malignant group
patients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II)
 Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
The assay for gastric cancer early detection will be built based on low-depth methylone sequencing followed with a multi-dimensional model construction with analysing several features such as methylation, fragmentation, and chromosomal copy number alternation.
non-malignant group
healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases
 Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
The assay for gastric cancer early detection will be built based on low-depth methylone sequencing followed with a multi-dimensional model construction with analysing several features such as methylation, fragmentation, and chromosomal copy number alternation.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The performance of each single feature and the ensemble model with integrated features for early GC detection [ Time Frame: 18 months ]
    The efficacy of each single feature-based model and the ensemble model comparing with pathologic diagnostic results, the gold standard, and gastroscope diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).

  2. The performance of each single feature and the ensemble model with integrated features for early GC detection in each clinical stage [ Time Frame: 18 months ]
    The efficacy of each single feature-based model and the ensemble model comparing with pathologic diagnostic results, the gold standard, and gastroscope diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).


Secondary Outcome Measures :
  1. The performance of the ensemble model in combination of possible GC related biomarkers such as PG, G17, and/or Hp levels for early GC detection [ Time Frame: 18 months ]
    The efficacy of the integrated model comparing with pathologic diagnostic results, the gold standard, and gastroscope diagnosis, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).


Biospecimen Retention:   Samples With DNA
peripheral blood samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study will enroll about 360 individuals who receive gastroscopy in The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, Shaanxi province, China.

Two groups will be formed based on gastroscopy results, malignant group and non-malignant group. The malignant group includes patients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II) while the non-malignant group contains healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases.

Criteria

Inclusion Criteria:

  1. Complete clinical info;
  2. Patients self-agree to join the study and with signed patient consent and good compliance.

The specific inclusion criteria for subjects to be included in the malignant group:

  1. According to the definition of AJCC's 8th Edition Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology and with pathological stages of stage I-IV, including patients with esophageal gastric junction adenocarcinoma (EGJ);
  2. Has not previously received any local or systematic anti-tumor treatment.

Exclusion Criteria:

  1. Diagnosed previously with any kind of malignant tumor;
  2. Have received total or partial gastrectomy;
  3. Have received bone marrow or organ transplantation;
  4. Have received blood transfusion in the past 6 months;
  5. Incomplete clinical info or unqualified to participate in the study.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05668910


Contacts
Layout table for location contacts
Contact: Ning Shen 400-080-0660 shen.ning1@genecast.com.cn
Contact: Yulong Li li.yulong@genecast.com.cn

Locations
Layout table for location information
China, Shaanxi
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital) Recruiting
Xi'an, Shaanxi, China
Contact: Gang Ji    13572152581    Jigang@fmmu.edu.cn   
Sponsors and Collaborators
GeneCast Biotechnology Co., Ltd.
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Investigators
Layout table for investigator information
Principal Investigator: Gang Ji The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: GeneCast Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT05668910    
Other Study ID Numbers: D-P200110-MCCGW-HP-7-GC
First Posted: December 30, 2022    Key Record Dates
Last Update Posted: December 30, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases