Machine Learning-driven Noninvasive Screening of Transcriptomics Liquid Biopsies for Early Diagnosis of Occult Peritoneal Metastases in Locally Advanced Gastric Cancer

Launched by QUN ZHAO · Jun 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to detect hidden cancer spread in patients with locally advanced gastric cancer, also known as stomach cancer. The researchers are using a technique called liquid biopsy, which involves taking a blood sample to look for specific cancer-related signals without needing invasive procedures. They are applying advanced computer technology, called machine learning, to analyze the RNA found in these blood samples. The goal is to see if this method can identify hidden cancer spread in the abdominal lining earlier and more accurately than traditional imaging techniques.

To participate in this trial, individuals must be adults aged 18 or older and have been diagnosed with locally advanced gastric cancer. They should have good overall health, with specific organ functions, and be willing to provide blood samples throughout the study. Participants can expect to provide blood samples at different points during their treatment, and their results will be compared with standard diagnostic methods. This innovative approach could lead to earlier and more effective treatment options, improving outcomes for patients with this challenging condition.

Gender

ALL

Eligibility 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.