Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2011-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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gastrointestinal cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients should sign a written informed consent .
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Ki Kang
Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology
Principal Investigators
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won ki kang, MD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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mi yeon kwon, RN
Role: primary
Other Identifiers
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2011-07-089
Identifier Type: -
Identifier Source: org_study_id