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Trial Title:
Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis
NCT ID:
NCT06278064
Condition:
Gastric Cancer
Esophagus Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Esophageal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Gastric Cancer
Description:
Patients diagnosed with gastric cancer, including early stage gastric and advanced
gastric cancer
Arm group label:
Gastric cancer group
Intervention type:
Other
Intervention name:
Esophagus Cancer
Description:
Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced
esophagus cancer
Arm group label:
esophagus cancer group
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. 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The Fourth Hospital of Hebei Medical University
Address:
City:
Shijiazhuang
Country:
China
Status:
Recruiting
Contact:
Last name:
Lianmei Zhao, Ph.D.
Facility:
Name:
Beijing Friendship Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Min, Ph.D.
Investigator:
Last name:
Li Min, Ph.D
Email:
Principal Investigator
Investigator:
Last name:
Chenjie Xu, Ph.D
Email:
Sub-Investigator
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yibin Xie, Ph.D
Start date:
February 1, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Beijing Friendship Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06278064
