Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02593591
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Study Start: 2015-11-06
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subject is at least 19 years of age.
2. Subject has a histologically or cytologically confirmed diagnosis of Colorectal cancer.
3. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed
4. They must have refractory or progressive disease for which there is no further curative therapy available.
5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status.
6. Must have a life expectancy of 3 months or more
7. Written and voluntary informed consent understood, signed and dated.

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Exclusion Criteria

1. Patients who do not have enough tissue for acquisition

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate	1 year

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	1 year
Duration of response	1 year
overall survival	1 year

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Seoul, Korea, Republic Of, Korea, Republic of