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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic Of
    • Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
      • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with treatment-refractory malignancy

Description

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.

Exclusion Criteria:

1. Patients who do not have enough tissue for acquisition

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Biomarker group; Advanced cancer undergoing genomic profiling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	1 year
Duration of response	1 year
overall survival	1 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2015
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2015-10-063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No