Early Gastric CancerNCT05269056
Early Detection of Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
An observational study of Early Gastric Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The purpose of this study is to enable non-invasive early detection of gastric cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Gastric Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 May 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 200 stage I/II gastric cancer patients and 100 non-cancer controls
Who may be able to join
- Age minimum 18 years
- Participants must have histologically and/or cytologically confirmed stage I/II gastric cancer
- Full access to the patients' clinical and pathological records
- Ability to understand and the willingness to sign a written informed consent document
- Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening
Who cannot join
- Participants must not be pregnant or breastfeeding
- Participants must not have prior cancer histories or a second non-gastric malignancy
- Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
- Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
- Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
- Participants with clinically important abnormalities or conditions unsuitable for blood collection
- Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or psychiatric illness/social situations that would limit compliance with study requirements or influence patient signing the written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital；Cancer hospital of the university of chinese academy of sciences
Hangzhou, Zhejiang, 310022
Pengfei Yu, MD，PhD, +86-571-88128031, ypfzmu@163.com
Xiangdong Cheng, MD，PhD
About this study
Official title: Early Detection of Stage I-II Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
The purpose of this study is to enable non-invasive early detection of gastric cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage gastric cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and microbiome, will be assessed to generate this model.
Read the detailed description
Improvement in the specificity of early cancer detection reduces financial and mental burdens from unnecessary screenings. Advances in liquid biopsy approaches have expanded the clinical scope of cell-free DNA analysis in cancer early detection, by moving away from cell-free DNA methylome toward an integrative approach that enables the simultaneous assessment of multimodal cell-free DNA features. Integration of liquid biopsy-based cancer early detection into the clinic requires optimization of detection techniques, large-scale studies and prospective clinical validation. In the early detection of gastric cancer, the top research priorities are to identify relevant target features and to improve the sensitivity and specificity of detection. This large-scale early detection study will randomly enroll 200 stage I/II pathologically diagnosed gastric patients and 100 age- and sex-matched healthy individuals upon providing written informed consent. Plasma samples will be collected and extracted cell-free DNA will be subjected to whole genome sequencing. We aimed to incorporate genome-wide copy number variations, cell-free DNA fragmentomics, and microbiome features into the development of a multimodal biomarker-based prediction model.
- Conditions
- Early Gastric Cancer
- Keywords
- Gastric cancer, Early stage, Plasma Cell-free DNA, Fragmentomic assay
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage I-II gastric cancer | Cell-free DNA collected from plasma samples of 200 patients with stage I-II gastric cancer will undergo whole-genome sequencing | |
| Healthy controls | Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of the model for detecting stage I/II gastric cancer
The area under curve of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate
Measured: 2 years
Secondary outcomes (3)
Sensitivity of the early detection model
The sensitivity of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate
Measured: 2 years
Specificity of the early detection model
The specificity of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate
Measured: 2 years
Area under curve of the early detection model at sequencing depth downsampling
The area under curve of the model at sequencing depth downsampling for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Sep 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion31 May 2023 (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 Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, MD, PhD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269056
- Sponsor's protocol ID
- IRB-2021-295
- Status last verified
- May 2022
- First submitted
- 28 Feb 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu P, Chen P, Wu M, Ding G, Bao H, Du Y, Xu Z, Yang L, Fang J, Huang X, Lai Q, Wei J, Yan J, Yang S, He P, Wu X, Shao Y, Su D, Cheng X. Multi-dimensional cell-free DNA-based liquid biopsy for sensitive early detection of gastric cancer. Genome Med. 2024 Jun 7;16(1):79. doi: 10.1186/s13073-024-01352-1.
PubMed 38849905
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Stage I-II Gastric Cancer Using Plasma Cell-free DNA Fragmentomics
- ClinicalTrials.gov ID
- NCT05269056
- Acronym / sponsor ID
- IRB-2021-295
- Conditions
- Early Gastric Cancer
- Keywords
- Gastric cancer, Early stage, Plasma Cell-free DNA, Fragmentomic assay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Nanjing Geneseeq Technology Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 7 Mar 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.
The purpose of this study is to enable non-invasive early detection of gastric cancer in high-risk populations through the establishment of a multimodal machine learning model using plasma cell-free DNA fragmentomics. Plasma cell-free DNA from early stage gastric cancer patients and healthy individuals will be subjected to whole-genome sequencing. Features, such as cell-free DNA fragmentation, copy number variations and microbiome, will be assessed to generate this model.
Detailed description
Improvement in the specificity of early cancer detection reduces financial and mental burdens from unnecessary screenings. Advances in liquid biopsy approaches have expanded the clinical scope of cell-free DNA analysis in cancer early detection, by moving away from cell-free DNA methylome toward an integrative approach that enables the simultaneous assessment of multimodal cell-free DNA features. Integration of liquid biopsy-based cancer early detection into the clinic requires optimization of detection techniques, large-scale studies and prospective clinical validation. In the early detection of gastric cancer, the top research priorities are to identify relevant target features and to improve the sensitivity and specificity of detection. This large-scale early detection study will randomly enroll 200 stage I/II pathologically diagnosed gastric patients and 100 age- and sex-matched healthy individuals upon providing written informed consent. Plasma samples will be collected and extracted cell-free DNA will be subjected to whole genome sequencing. We aimed to incorporate genome-wide copy number variations, cell-free DNA fragmentomics, and microbiome features into the development of a multimodal biomarker-based prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage I-II gastric cancer | – | –Cell-free DNA collected from plasma samples of 200 patients with stage I-II gastric cancer will undergo whole-genome sequencing |
| Healthy controls | – | –Cell-free DNA collected from plasma samples of 100 non-cancer individuals will serve as controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 200 stage I/II gastric cancer patients and 100 non-cancer controls
Key inclusion criteria (5 listed)
- Age minimum 18 years
- Participants must have histologically and/or cytologically confirmed stage I/II gastric cancer
- Full access to the patients' clinical and pathological records
- Ability to understand and the willingness to sign a written informed consent document
- Non-cancer controls are sex- and age-matched individuals without presence of any tumors or nodules or any other severe chronic diseases through systematic screening
Key exclusion criteria (7 listed)
- Participants must not be pregnant or breastfeeding
- Participants must not have prior cancer histories or a second non-gastric malignancy
- Participants must not have had any form of cancer treatment before enrollment or plasma collection, including surgery, chemotherapy, radiotherapy, targeted therapy and immunotherapy
- Participants must not present medical conditions of fever or have acute or immunological diseases that required treatment 14 days before plasma collection
- Participants who underwent organ transplant or allogenic bone marrow or hematopoietic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under curve of the model for detecting stage I/II gastric cancer
Time frame: 2 years
The area under curve of the model for the ultrasensitive early detection of stage I/II gastric cancer would be evaluate
3 secondary outcomes
Sensitivity of the early detection model
Time frame: 2 years
Specificity of the early detection model
Time frame: 2 years
Area under curve of the early detection model at sequencing depth downsampling
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 38849905Yu P, Chen P, Wu M, Ding G, Bao H, Du Y, Xu Z, Yang L, Fang J, Huang X, Lai Q, Wei J, Yan J, Yang S, He P, Wu X, Shao Y, Su D, Cheng X. Multi-dimensional cell-free DNA-based liquid biopsy for sensitive early detection of gastric cancer. Genome Med. 2024 Jun 7;16(1):79. doi: 10.1186/s13073-024-01352-1.
- Individual participant dataSharing planned: No
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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.
Xiangdong Cheng, MD, PhD principal investigator
Zhejiang Cancer Hospital
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 Early Gastric Cancer, run by Zhejiang Cancer Hospital 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 7 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 2 Jun 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 Pengfei Yu, MD, PhD (86-571-88128031, ypfzmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of the model for detecting stage I/II gastric cancer (time frame: 2 years). 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 NCT05269056, 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 2 Jun 2022.