Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
1 other identifier
observational
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2015
CompletedStudy Start
First participant enrolled
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
November 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 15, 2022
June 1, 2022
7.1 years
October 26, 2015
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Response rate
1 year
Secondary Outcomes (3)
Progression Free Survival
1 year
Duration of response
1 year
Overall survival
1 year
Study Arms (1)
Biomarker group
Advanced cancer undergoing genomic profiling
Eligibility Criteria
Patients with treatment-refractory malignancy
You may qualify if:
- 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.
You may not qualify if:
- \. Patients who do not have enough tissue for acquisition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD,Division of hematology-oncology,Department of medicine
Study Record Dates
First Submitted
October 26, 2015
First Posted
November 2, 2015
Study Start
October 28, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
June 15, 2022
Record last verified: 2022-06