Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-25 @ 1:43 AM
NCT ID:
NCT06478394
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06478394
Study Brief:
Protocol Section:
NCT06478394