Gastric CancerNCT06278064
Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis
An observational study of Gastric Cancer and Esophagus Cancer, run by Beijing Friendship Hospital at 3 sites in China.
Trial summary
This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Esophagus Cancer
- What is being tested?
- Gastric Cancer and Esophagus Cancer
- How many people
- 562 participants
- Where
- 3 sitesChina
- Study dates
- 1 Feb 2024to 30 Jun 2025
- 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: The study population included a range of subjects with upper gastrointestinal cancers and diseases, including patients with malignant and benign upper gastrointestinal diseases and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Who may be able to join
- Confirmed diagnosis of upper gastrointestinal cancers or benign upper gastrointestinal diseases through gastroscopy and pathological examination.
- Collection of plasma samples prior to surgical treatment.
- Availability of complete clinical data.
Who cannot join
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before surgical treatment.
- Incomplete clinical data.
- Pregnancy status
Trial locations and contacts
3 sites in 1 country.
Chenjie Xu, Ph.D. contact
China3 sites, 3 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing
Li Min, Ph.D.
Li Min, Ph.D
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yibin Xie, Ph.D
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Lianmei Zhao, Ph.D.
About this study
Official title: Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers
This study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy.
Read the detailed description
This study employs a multicenter, retrospective cohort design, collecting and analyzing plasma and tissue exosome protein data from patients with upper gastrointestinal tumors (Stage I-II), upper gastrointestinal benign diseases, and a healthy control group who have visited Beijing Friendship Hospital, and other relevant sub-center hospitals over the past five years. Concurrently, relevant clinical and pathological information is recorded.
Samples from the training cohort undergo traditional quantitative exosome proteomic analysis (Data-Independent Acquisition, DIA) and single-vesicle membrane protein analysis (PBA). A comprehensive upper gastrointestinal tumor-specific exosome protein database is constructed, incorporating extensive information. Subsequently, bioinformatics methods are employed to conduct in-depth analysis of the extensive protein data, screening for proteins with high specificity for upper gastrointestinal tumors, capable of direct detection on the exosome membrane surface. By establishing and evaluating diagnostic models, we aim to quantify the diagnostic potential of these markers, providing a scientific basis for future early screening methods for upper gastrointestinal tumors.
Finally, external validation of these protein markers in an independent validation cohort ensures their reliability and stability across different patient populations. The academic significance of this research lies in its thorough exploration of exosome proteomics in early cancer diagnosis, offering potential innovative breakthroughs for academic progress and clinical practice in this field.
- Conditions
- Gastric Cancer, Esophagus Cancer
- Being tested
- Gastric Cancer, Esophagus Cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric CancerOther
Patients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer
Esophagus CancerOther
Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer group | Patients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer Receives: Other: Gastric Cancer | |
| esophagus cancer group | Patients diagnosed with esophagus cancer, including early esophagus cancer and advanced esophagus cancer Receives: Other: Esophagus Cancer | |
| Non-cancer group | Patients diagnosed with benign upper gastrointestinal diseases or healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma proteins in patients with gastric cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Measured: Before receiving treatment for gastric cancer
Plasma proteins in patients with esophagus cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Measured: Before receiving treatment for esophagus cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 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 Beijing Friendship 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 562 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Li, Beijing Friendship Hospital
- Investigators
- Li Min, Ph.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278064
- Sponsor's protocol ID
- BFHHZML20240006
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT06278064
- Acronym / sponsor ID
- BFHHZML20240006
- Conditions
- Gastric Cancer, Esophagus Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 562 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Feb 2024 (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 study constitutes a case-control investigation employing a retrospective approach. Plasma samples from individuals with esophageal cancer, benign esophageal diseases, gastric cancer, benign gastric diseases, and a healthy control group were systematically collected. Advanced Data-Independent Acquisition (DIA) proteomics and single-vesicle membrane protein detection techniques were employed to quantify protein content within exosomes. Specific protein biomarkers indicative of early-stage upper gastrointestinal tumors were identified. External validation of these protein markers was conducted using Parallel Reaction Monitoring (PRM) technology on an independent validation cohort. The objective is to establish protein marker predictions for early diagnosis of upper gastrointestinal tumors and prognostication of therapeutic efficacy.
Detailed description
This study employs a multicenter, retrospective cohort design, collecting and analyzing plasma and tissue exosome protein data from patients with upper gastrointestinal tumors (Stage I-II), upper gastrointestinal benign diseases, and a healthy control group who have visited Beijing Friendship Hospital, and other relevant sub-center hospitals over the past five years. Concurrently, relevant clinical and pathological information is recorded.
Samples from the training cohort undergo traditional quantitative exosome proteomic analysis (Data-Independent Acquisition, DIA) and single-vesicle membrane protein analysis (PBA). A comprehensive upper gastrointestinal tumor-specific exosome protein database is constructed, incorporating extensive information. Subsequently, bioinformatics methods are employed to conduct in-depth analysis of the extensive protein data, screening for proteins with high specificity for upper gastrointestinal tumors, capable of direct detection on the exosome membrane surface. By establishing and evaluating diagnostic models, we aim to quantify the diagnostic potential of these markers, providing a scientific basis for future early screening methods for upper gastrointestinal tumors.
Finally, external validation of these protein markers in an independent validation cohort ensures their reliability and stability across different patient populations. The academic significance of this research lies in its thorough exploration of exosome proteomics in early cancer diagnosis, offering potential innovative breakthroughs for academic progress and clinical practice in this field.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer group | – | Other: Gastric CancerPatients diagnosed with gastric cancer, including early gastric cancer and advanced gastric cancer |
| esophagus cancer group | – | Other: Esophagus CancerPatients diagnosed with esophagus cancer, including early esophagus cancer and advanced esophagus cancer |
| Non-cancer group | – | –Patients diagnosed with benign upper gastrointestinal diseases or healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population included a range of subjects with upper gastrointestinal cancers and diseases, including patients with malignant and benign upper gastrointestinal diseases and healthy controls, who were admitted to the main study center and other collaborating sub-center hospitals.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of upper gastrointestinal cancers or benign upper gastrointestinal diseases through gastroscopy and pathological examination.
- Collection of plasma samples prior to surgical treatment.
- Availability of complete clinical data.
Key exclusion criteria (5 listed)
- Previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection.
- Coexistence of other systemic tumors.
- Absence of plasma sample collection before surgical treatment.
- Incomplete clinical data.
- Pregnancy status
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 |
|---|---|---|
| Gastric CancerPatients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer | Other | Gastric cancer group |
| Esophagus CancerPatients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer | Other | esophagus cancer group |
Primary outcome
Plasma proteins in patients with gastric cancer
Time frame: Before receiving treatment for gastric cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Plasma proteins in patients with esophagus cancer
Time frame: Before receiving treatment for esophagus cancer
The outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Chenjie Xu, Ph.D. contact
Li Min, Ph.D. principal investigator
Beijing Friendship Hospital
3 sites 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 Esophagus Cancer, run by Beijing Friendship Hospital at 3 sites 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 3 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Li Min, Ph.D. (+86 13552652141, minli@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma proteins in patients with gastric cancer (time frame: Before receiving treatment for gastric cancer). 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?
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 26 Feb 2024.