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
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Condition or disease | Intervention/treatment |
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Gastric Cancer | Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA |
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 |
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 |
Group/Cohort | Intervention/treatment |
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malignant group
patients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II)
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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
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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. |
- 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).
- 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
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- Complete clinical info;
- 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:
- 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);
- Has not previously received any local or systematic anti-tumor treatment.
Exclusion Criteria:
- Diagnosed previously with any kind of malignant tumor;
- Have received total or partial gastrectomy;
- Have received bone marrow or organ transplantation;
- Have received blood transfusion in the past 6 months;
- Incomplete clinical info or unqualified to participate in the study.
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
Contact: Ning Shen | 400-080-0660 | shen.ning1@genecast.com.cn | |
Contact: Yulong Li | li.yulong@genecast.com.cn |
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 |
Principal Investigator: | Gang Ji | The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |