Biomarker Analysis of Gastrointestinal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01484444
First received: November 22, 2011
Last updated: December 4, 2011
Last verified: December 2011
  Purpose

BIOMARKER ANALYSES

  1. FNA Sample:

    From each enrolled patient who meets the inclusion criteria, FNA sample will only be taken .

    FNA will be carried out only in patients with feasible biopsy or FNA site. Ascites or pleural fluid will be collected for analysis

  2. Blood Samples From each enrolled patient who meets the inclusion criteria, blood samples will be collected. 3 mL blood sample will be collected .
  3. tumor tissue Archived Tumor Tissue (Slides) Samples Primary tumor and/or a metastatic lesion collected. Approximately 5 unstained slides (if available) are collected.

Condition
Gastrointestinal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Analysis of Gastrointestinal Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Analyzed of DNA mutations [ Time Frame: 24months ] [ Designated as safety issue: No ]
    To estimate genotypes concerning DNA repair (ERCC1, XPD, XRCC1) and detoxification (GSTP1)


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
gastrointestinal cancer

Detailed Description:

Recently, a great leap has been accomplished in discovering somatic mutations in human cancer genomes. With the advent of molecularly targeted therapy, somatic mutations have attracted more attention from cancer researchers. Driver mutations confer growth advantage on the cell in which they occur, are causally implicated in cancer development and have therefore been positively selected. In contrast, passenger mutations are biologically neutral and do not confer growth advantage. Hence, driver somatic mutations are conventionally the optimal target for cancer cells. Given the growing evidence of ethnic difference in distribution of somatic mutations, we aim to survey actionable somatic mutations in Asian prevalent cancer.

Ability to assess multiple biomarkers using FNA samples could provide a breakthrough in gastrointestinal cancer clinical studies. FNAs are minimally invasive and, therefore, more acceptable for serial tumor sampling. Furthermore, the cells removed with this method frequently represent relatively pure tumor cell population, and can be processed within minutes after removal from the tumor; therefore, proteomic profiles of FNA specimens likely resemble the in vivo profiles very closely. In addition, tumor cells from metastatic sites obtained using FNA may provide site specific metastatic tumor profile. Acquired resistances to therapies is well known in various cancer types.1, 2 Serial sampling of tumor tissue by FNA will provide important resources to monitor tumor changes as a function of time and therapy.

There have been numerous studies reporting the detection of carcinoma cells in the blood of patients with solid tumors. Detection of CTCs (Circulating Tumor Cells) before initiation of first-line therapy in patients with metastatic breast cancer is highly predictive of progression free survival and overall survival.3-5 These studies led to the FDA clearance of the vertex CellSearch technology. The prognostic implication of detecting CTCs prior to initiating therapy raises important questions about the biological attributes of these cells. CTCs are found in most metastatic diseases and it may be reflective of the status of the recurrent tumor looking for alternate site to colonize. However, not all CTCs would successfully establish metastatic colonies. Having the ability to profile tumors at different metastatic sites together with CTCs could provide information on the subset of most robust CTCs with highest metastatic potentials. In addition CTCs could provide alternative source of tumor cells that may be used to detect tumor changes as the cancer progresses and therapy continued or modified.

The expression/activation profiling of kinases and other signal transduction pathway molecules along with markers critical for triggering angiogenesis on a serial sampling of tumor and tumor associated tissues will provide valuable information on changes occurring in tumor cells as a function of time and therapies. This temporal and spatial profiling of tumor progression will enable clinicians to monitor rapidly 'evolving' cancer signatures in each patient. The temporal and site-specific profiling of CTCs and FNAs must then utilize highly sensitive and specific method to interrogate limited amount of cancer cells in such samples. Based on these results, we plan to design genome-directed clinical trials in these tumor types.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gastrointestinal cancer Patients.

Criteria

Inclusion Criteria:

  • Patients with histologically confirmed gastrointestinal cancer.
  • Patients should sign a written informed consent .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484444

Contacts
Contact: mi yeon Kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN    +82-2-3410-1248    miyeon.kwon@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: won ki kang, MD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01484444     History of Changes
Other Study ID Numbers: 2011-07-089
Study First Received: November 22, 2011
Last Updated: December 4, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 28, 2014