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OpenTrials
Completed

NCT Number: NCT02593591

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is at least 19 years of age.
  • Subject has a histologically or cytologically confirmed diagnosis of Colorectal cancer.
  • 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.

Exclusion criteria

  • Patients who do not have enough tissue for acquisition

Treatment and study plan

Primary outcomes

  1. Response rate

    Time frame: 1 year

Secondary outcomes

  1. Progression Free Survival

    Time frame: 1 year

  2. Duration of response

    Time frame: 1 year

  3. overall survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2015
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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