Gastric CancerNCT05668910
Gastric Cancer Early Detection by Multi-dimensional Analysis of cfDNA
An observational study of Gastric Cancer, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- whole genomic methylation and fragmentation profile analysis of cfDNA
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yulong Li contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital)
Xi'an, Shaanxi
Gang Ji, 13572152581, Jigang@fmmu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- whole genomic methylation and fragmentation profile analysis of cfDNA
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole genomic methylation and fragmentation profile analysis of cfDNAGenetic
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 group | Role | What they receive |
|---|---|---|
| malignant group | patients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II) Receives: 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 Receives: Genetic: whole genomic methylation and fragmentation profile analysis of cfDNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The performance of each single feature and the ensemble model with integrated features for early GC detection
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).
Measured: 18 months
The performance of each single feature and the ensemble model with integrated features for early GC detection in each clinical stage
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).
Measured: 18 months
Secondary outcomes (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
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Sep 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Air Force Medical University
- Responsible party
- Sponsor
- Investigators
- Gang Ji, Principal investigator, The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668910
- Sponsor's protocol ID
- D-P200110-MCCGW-HP-7-GC
- Status last verified
- Nov 2022
- First submitted
- 12 Dec 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Han Y, Wei J, Wang W, Gao R, Shen N, Song X, Ni Y, Li Y, Xu LD, Chen W, Li X. Multidimensional Analysis of a Cell-Free DNA Whole Methylome Sequencing Assay for Early Detection of Gastric Cancer: Protocol for an Observational Case-Control Study. JMIR Res Protoc. 2023 Sep 20;12:e48247. doi: 10.2196/48247.
PubMed 37728978
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05668910
- Acronym / sponsor ID
- D-P200110-MCCGW-HP-7-GC
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- GeneCast Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Air Force Medical University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| malignant group | – | Genetic: whole genomic methylation and fragmentation profile analysis of cfDNApatients diagnosed with high grade Intraepithelial neoplasia or GC (> 50% of patients in stage I and II) |
| non-malignant group | – | Genetic: whole genomic methylation and fragmentation profile analysis of cfDNAhealthy individuals and patients with non-atrophic gastritis, gastric ulcer, gastric polyp or other benign gastric diseases |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Complete clinical info;
- Patients self-agree to join the study and with signed patient consent and good compliance.
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole genomic methylation and fragmentation profile analysis of cfDNAThe 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. | Genetic | malignant group, non-malignant group |
Primary outcome
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).
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Derived from this study: PubMed 37728978Han Y, Wei J, Wang W, Gao R, Shen N, Song X, Ni Y, Li Y, Xu LD, Chen W, Li X. Multidimensional Analysis of a Cell-Free DNA Whole Methylome Sequencing Assay for Early Detection of Gastric Cancer: Protocol for an Observational Case-Control Study. JMIR Res Protoc. 2023 Sep 20;12:e48247. doi: 10.2196/48247.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulong Li contact
Gang Ji principal investigator
The First Affiliated Hospital of Air Force Military Medical University (Xijing Hospital), Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by GeneCast Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning Shen (400-080-0660, shen.ning1@genecast.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The performance of each single feature and the ensemble model with integrated features for early GC detection (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.