Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Response rate
Study Overview
Brief Summary
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important.
To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is at least 19 years of age.
- •Subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc.
- •Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
- •They must have refractory or progressive disease for which there is no further curative therapy available.
- •Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
- •Must have a life expectancy of 3 months or more
- •Written and voluntary informed consent understood, signed and dated.
Exclusion Criteria
- •Patients who do not have enough tissue for acquisition
Outcomes
Primary Outcomes
Response rate
Time Frame: 1 year
Secondary Outcomes
- Progression Free Survival(1 year)
- Duration of response(1 year)
- Overall survival(1 year)
Investigators
Jeeyun Lee
MD,PhD,Division of hematology-oncology,Department of medicine
Samsung Medical Center