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Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA

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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.

Tracking Information
First Submitted Date December 12, 2022
First Posted Date December 30, 2022
Last Update Posted Date December 30, 2022
Actual Study Start Date September 1, 2022
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 25, 2022)
  • 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).
  • 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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 25, 2022)		 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
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
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
peripheral blood samples
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.
Condition Gastric Cancer
Intervention 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.
Study Groups/Cohorts
  • malignant group
    patients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II)
    Intervention: Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
  • non-malignant group
    healthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases
    Intervention: Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 25, 2022)		 360
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Ning Shen 400-080-0660 shen.ning1@genecast.com.cn
Contact: Yulong Li li.yulong@genecast.com.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05668910
Other Study ID Numbers D-P200110-MCCGW-HP-7-GC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party GeneCast Biotechnology Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor GeneCast Biotechnology Co., Ltd.
Original Study Sponsor Same as current
Collaborators The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Investigators
Principal Investigator: Gang Ji The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
PRS Account GeneCast Biotechnology Co., Ltd.
Verification Date November 2022