Using machine learning to detect hidden cancer spread in stomach cancer patients
Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer
This study is testing whether a new blood test using machine learning can help find hidden cancer spread in stomach cancer patients earlier than traditional imaging methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hebei Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT06478394 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of machine learning technology combined with liquid biopsies to identify occult peritoneal metastases in patients with locally advanced gastric cancer. By analyzing blood samples, the study aims to provide a noninvasive method for early diagnosis of hidden cancer spread that is often missed by traditional imaging techniques. The goal is to enhance treatment strategies and improve patient outcomes through earlier detection of these metastases. Participants will undergo laparoscopic exploration as part of the evaluation process.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of locally advanced gastric cancer and adequate organ function.
Not a fit: Patients with early-stage gastric cancer or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of hidden cancer spread, improving treatment options and outcomes for patients with locally advanced gastric cancer.
How similar studies have performed: While the use of machine learning and liquid biopsies is a growing field, this specific approach to detecting occult peritoneal metastases in gastric cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Diagnosis of Locally Advanced Gastric Cancer (LAGC): Patients must have a confirmed diagnosis of locally advanced gastric cancer, as determined by standard diagnostic procedures such as imaging and histopathological examination. Age: Participants must be adults aged 18 years or older. Consent: Patients must be able to provide informed consent to participate in the study. Adequate Organ Function: Participants should have adequate bone marrow, liver, and kidney function as defined by specific laboratory criteria (e.g., specific levels of hemoglobin, platelet count, liver enzymes, and creatinine clearance). Performance Status: Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, indicating they are fully active, restricted in physically strenuous activity but ambulatory, or capable of all self-care but unable to carry out any work activities. Willingness to Provide Blood Samples: Participants must be willing to provide blood samples at specified time points throughout the study. Previous Treatment: Patients who have received prior treatments for gastric cancer (e.g., chemotherapy, radiation therapy, or surgery) may be included, provided there is a sufficient washout period as determined by the study protocol. Exclusion Criteria: * Distant Metastases: Patients with confirmed distant metastases (beyond the peritoneum) are excluded. Other Malignancies: Individuals with a history of other malignancies within the past five years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix. Severe Comorbid Conditions: Patients with severe or uncontrolled comorbid conditions, such as significant cardiovascular disease, uncontrolled diabetes, severe infections, or other conditions that could interfere with the study participation or outcomes. Pregnancy and Lactation: Pregnant or lactating women are excluded due to potential risks to the fetus or infant. Immunocompromised Status: Patients who are immunocompromised, such as those with HIV/AIDS, or who are receiving immunosuppressive therapy. Concurrent Participation in Other Clinical Trials: Individuals currently participating in another clinical trial that could interfere with this study's procedures or outcomes. Allergies to Study Materials: Patients with known allergies to any components of the study materials used for liquid biopsy processing and analysis. Non-compliance: Individuals deemed unable or unwilling to comply with the study procedures and follow-up requirements.
Where this trial is running
Shijiazhuang, Hebei
- Department of General Surgery — Shijiazhuang, Hebei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.