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Exosome-based Liquid Biopsies for Upper Gastrointestinal Cancers Diagnosis

Plasma Extracellular Vesicle Quantitative Proteomic Analysis for Early Diagnosis of Upper Gastrointestinal Cancers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06278064
Enrollment
562
Registered
2024-02-26
Start date
2024-02-01
Completion date
2025-06-30
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagus Cancer, Gastric Cancer

Brief 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.

Interventions

OTHERGastric Cancer

Patients diagnosed with gastric cancer, including early stage gastric and advanced gastric cancer

OTHEREsophagus Cancer

Patients diagnosed with esophagus cancer, including early esophagus gastric and advanced esophagus cancer

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma proteins in patients with gastric cancerBefore receiving treatment for gastric cancerThe outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology
Plasma proteins in patients with esophagus cancerBefore receiving treatment for esophagus cancerThe outcome will be tested by Data-Independent Acquisition (DIA) proteomics technology

Countries

China

Contacts

Primary ContactLi Min, Ph.D.
minli@ccmu.edu.cn+86 13552652141
Backup ContactChenjie Xu, Ph.D.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026