- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01831609
Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer
June 13, 2022 updated by: Jeeyun Lee, Samsung Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeeyun Lee, MD
- Phone Number: 822-3410-3459
- Email: jyun.lee@samsung.com
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Samsung Medical Center
-
Contact:
- Hyejin Jang, RN
- Phone Number: 822-3410-6859
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
1. Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
Description
Inclusion Criteria:
- Patients with histologically confirmed gastrointestinal, genitourinary, sarcoma, rare cancer
- Written informed consent
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeeyun Lee, professor, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2011
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2024
Study Registration Dates
First Submitted
April 7, 2013
First Submitted That Met QC Criteria
April 12, 2013
First Posted (Estimate)
April 15, 2013
Study Record Updates
Last Update Posted (Actual)
June 15, 2022
Last Update Submitted That Met QC Criteria
June 13, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-07-089-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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