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

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02593578
Collaborator
(none)
2,000
Enrollment
1
Location
97.1
Anticipated Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.
    Actual Study Start Date :
    Oct 28, 2015
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Biomarker group

    Advanced cancer undergoing genomic profiling

    Outcome Measures

    Primary Outcome Measures

    1. Response rate [1 year]

    Secondary Outcome Measures

    1. Progression Free Survival [1 year]

    2. Duration of response [1 year]

    3. Overall survival [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subject is at least 19 years of age.

    2. Subject has a histologically or cytologically confirmed diagnosis of hepatocellular carcinoma/rare cancer, melanoma, neuroendocrine tumor, sarcoma etc.

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeeyun Lee, MD,PhD,Division of hematology-oncology,Department of medicine, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02593578
    Other Study ID Numbers:
    • 2015-10-062
    First Posted:
    Nov 1, 2015
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Neoplasms
    Neoplasms, Second Primary

    Study Results

    No Results Posted as of Jun 15, 2022