Clinical Research Directory

Master Protocol for Basket Clinical Trials of Targeted Therapies Based on Proteome and Whole Exome Sequencing Screening in Patients With Advanced Solid Tumors

Sponsor: National Cancer Center, Korea

Summary

Study Overview This study evaluates a proteogenomic screening platform to identify precise therapeutic targets for patients with advanced solid tumors. While traditional precision medicine relies on DNA sequencing (genomics), this research adds protein analysis (proteomics) to better understand how cancer cells function and respond to treatment. 1. Background and Purpose Standard genomic testing often fails to predict whether a patient will respond to a specific drug because DNA mutations do not always result in active protein expression. By integrating Whole Exome Sequencing (WES) with phosphoproteomics (the study of protein activation), this study aims to: * Identify active signaling networks that DNA testing alone might miss. * Evaluate the feasibility and cost-effectiveness of this integrated platform compared to traditional methods. * Help match patients to the most effective targeted therapies through a "Basket Trial" framework, where treatment is based on molecular signatures rather than where the cancer started in the body. 2. Target Population * Adults (19 years and older) with histologically confirmed metastatic or locally advanced solid tumors. * Patients with Stage III, IV, or those at a high risk of recurrence. * Participants must have a life expectancy of at least 3 months and a good performance status (ECOG 0-2). 3. Study Procedures * Specimen Collection: Researchers will collect tumor tissue through biopsy or surgery. To preserve the integrity of proteins, these samples must be snap-frozen (Fresh-Frozen) immediately after extraction. * Analysis: The study will analyze the tissue and blood samples to characterize the patient's unique proteogenomic profile. * Treatment Assignment: If a specific molecular variant is identified (such as HRD or ALK/ROS1/MET signatures), and a matching sub-protocol is available, the patient may be enrolled in a targeted therapy trial. Patients who do not meet these criteria will continue with the standard of care. 4. Expectations and Logistics This is a multicenter, prospective screening study involving a nationwide logistics system to ensure high-quality sample transport. The study aims to enroll a total of 2,800 subjects (approximately 560 per year) and is expected to continue through December 31, 2028. 5. Potential Benefits and Risks * Benefits: Participants may gain access to targeted therapies based on their cancer's specific molecular profile. * Risks: While the study does not add new invasive procedures beyond standard care, there are potential psychosocial risks related to genomic findings and the sharing of de-identified data for research purposes.

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