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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593591
• Other study ID #: 2015-10-063
• Status: Completed
• Start date: November 6, 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Neoplasm Metastasis

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Seoul, Korea, Republic Of

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		1 year
Secondary	Progression Free Survival		1 year
Secondary	Duration of response		1 year
Secondary	overall survival		1 year