Gastric CancerNCT05991947
Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
An observational study of Gastric Cancer and Healthy, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Healthy
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2025
- How long will I take part?
- 5 Years
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Number of Participants and Total Enrollment: Zhejiang Cancer Hospital: 700/700 (350 cases of gastric cancer patients, 350 cases of healthy individuals) Sichuan Cancer Hospital: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals) The Sixth Affiliated Hospital of Sun Yat-sen University: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals)
Who may be able to join
- Age between 18 and 100 years.
- ECOG performance status of 0 or 1.
- Pathologically confirmed Stage I-III gastric cancer patients.
- Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
- Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.
Who cannot join
- Presence of other hereditary diseases or other tumors.
- Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
- Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
- Pregnant women.
- Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
- Severe cardiovascular diseases, uncontrolled infections, or other uncontrollable comorbidities.
- Subjects or family members unable to comprehend the conditions and objectives of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310000
Xiangdong Cheng, PhD., +0086-0571-88128041, chengxd516@126.com
About this study
This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.
Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.
- Conditions
- Gastric Cancer, Healthy
- Being tested
- No intervention
- Keywords
- Gastric Cancer, Proteomics, Diagnostic model
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention measures are needed.
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer patients | Not described Receives: Other: No intervention | |
| healthy individuals | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in ctDNA gene and tumor-specific proteins expression
Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.
Measured: First day in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start1 Mar 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991947
- Sponsor's protocol ID
- IRB-2023-427
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Experimental Study on Key Technologies for Early Screening of Gastric Cancer
- ClinicalTrials.gov ID
- NCT05991947
- Acronym / sponsor ID
- IRB-2023-427
- Conditions
- Gastric Cancer, Healthy
- Keywords
- Gastric Cancer, Proteomics, Diagnostic model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Aug 2023 (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.
This project aims to collect peripheral blood samples from newly diagnosed gastric cancer patients and healthy individuals. Various techniques such as cfDNA sequencing, proteomics, and fragmentomics will be employed to analyze differences in the expression of ctDNA mutations, fragmentomics, and protein biomarkers between gastric cancer patients and healthy individuals. A new comprehensive diagnostic model will be established and its diagnostic value (sensitivity, specificity, accuracy, etc.) for gastric cancer will be validated.
Specifically, the study will involve the following subjects and quantities: 700 participants from Zhejiang Cancer Hospital (350 gastric cancer patients and 350 healthy individuals), 200 participants from Sichuan Cancer Hospital (100 gastric cancer patients and 100 healthy individuals), and 200 participants from the Sixth Affiliated Hospital of Sun Yat-sen University (100 gastric cancer patients and 100 healthy individuals). Peripheral blood samples (a total of 15mL from each participant, collected in 3 tubes) will be collected from all subjects. The collected blood samples will undergo multi-omics sequencing including cfDNA methylation sequencing, proteomics, and genomics to establish a multi-omics-based early diagnostic model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gastric cancer patients | – | Other: No intervention |
| healthy individuals | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Number of Participants and Total Enrollment: Zhejiang Cancer Hospital: 700/700 (350 cases of gastric cancer patients, 350 cases of healthy individuals) Sichuan Cancer Hospital: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals) The Sixth Affiliated Hospital of Sun Yat-sen University: 200/200 (100 cases of gastric cancer patients, 100 cases of healthy individuals)
Key inclusion criteria (5 listed)
- Age between 18 and 100 years.
- ECOG performance status of 0 or 1.
- Pathologically confirmed Stage I-III gastric cancer patients.
- Patients who have not undergone any anti-tumor treatment (including chemotherapy, radiotherapy, targeted therapy, surgery, anesthesia, etc.) before blood collection.
- Subjects and their family members who can comprehend the research protocol and are willing to participate in the study, providing written informed consent.
Key exclusion criteria (7 listed)
- Presence of other hereditary diseases or other tumors.
- Severe inflammatory reactions caused by acute illnesses within 14 days prior to blood draw or use of steroids.
- Previous organ transplantation, stem cell transplantation, bone marrow transplantation, or blood transfusion within the last month before enrollment.
- Pregnant women.
- Participation in other clinical trials requiring medication intake within the last 60 days (including anesthesia).
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 |
|---|---|---|
| No interventionNo intervention measures are needed. | Other | gastric cancer patients, healthy individuals |
Primary outcome
Differences in ctDNA gene and tumor-specific proteins expression
Time frame: First day in hospital
Collect 15ml of peripheral blood from subjects, extract ctDNA, and detect mutations in 18 genes (AKT1, APC, BRAF, CDKN2A, CTNNB1, EGFR, FBXW7, FGFR2, GNAS, HRAS, KRAS, NRAS, PIK3CA, PPP2R1A, PTEN, TP53, TOP2A, RNF43) and the expression levels of 9 tumor-specific proteins (CA-125, CA 19-9, CEA, HGF, IL-6, OPN, Prolactin, AFP, HE4) using the FireflyTM method based on amplicon library deep sequencing. Determine the performance indicators including sensitivity, specificity, and accuracy of the existing AccuScreen system and diagnostic model for early screening of gastric cancer. By conducting tests on 10 samples, explore the genomic fragments of gastric cancer, establish targets for ctDNA fragmentomics (fragment length, cleavage sites, end preferences, etc.), and analysis algorithms for gastric cancer fragmentomics, to further evaluate the feasibility of enhancing sensitivity and specificity for early gastric cancer screening through ctDNA fragmentomics detection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No. This study does not involve clinical trials of drugs; it is solely designed to ensure the confidentiality of patient information. For participant information (such as names and ages), a coding system will be used instead of real names. After enrollment, each case will be assigned an enrollment number. Throughout the entire study, only the main researchers within the research team will have access to participants' real personal data (names, ages) in the electronic database. Distribution and sharing are prohibited. During the publication of articles, the main researchers within the research team will replace participant privacy information (names) with sample codes to achieve de-identification. Furthermore, the protection of participants' personal information will be maintained throughout the study, and any dissemination or leakage is strictly prohibited.
Related trials for Gastric Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
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.
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 and Healthy, 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 5 Sep 2024. 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 Xiangdong Cheng, Professor (+86-13968032995, chengxd@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in ctDNA gene and tumor-specific proteins expression (time frame: First day in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.