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Trial Title:
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
NCT ID:
NCT05668910
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
whole genomic methylation and fragmentation profile analysis of cfDNA
Description:
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.
Arm group label:
malignant group
Arm group label:
non-malignant group
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Ji
Phone:
13572152581
Email:
Jigang@fmmu.edu.cn
Start date:
September 1, 2022
Completion date:
March 31, 2024
Lead sponsor:
Agency:
GeneCast Biotechnology Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Agency class:
Other
Source:
GeneCast Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05668910
