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Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer

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ClinicalTrials.gov Identifier: NCT01831609
Recruitment Status : Recruiting
First Posted : April 15, 2013
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief Summary:
To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.

Condition or disease
Sarcoma

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer
Actual Study Start Date : August 31, 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Biomarker analyses to predict treatment response in metastatic cancer [ Time Frame: 3 year ]
    Using patient derived tumor cells, predictive biomarker analyses (DNA, RNA protein levels etc) will be assessed.


Biospecimen Retention:   Samples With DNA
Pleural fluid, ascites, fine needle aspirations, other body fluids (i.e. CSFs)prospectively. Primary cultures, Xenografts.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
  2. Written informed consent
  3. body fluid derived from cancer, available for drainage and collection

Exclusion Criteria:

  • patients who do not give informed consent form for research use of biomaterials/biospecimens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831609


Contacts
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Contact: Jeeyun Lee, MD 822-3410-3459 jyun.lee@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hyejin Jang, RN    822-3410-6859      
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jeeyun Lee, professor Samsung Medical Center

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Responsible Party: Jeeyun Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01831609     History of Changes
Other Study ID Numbers: 2011-07-089-013
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Keywords provided by Jeeyun Lee, Samsung Medical Center:
Gastrointestinal
Genitourinary
Rare Cancer

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