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Louisville Cooperative Tissue Biorepository (LCTB)

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ClinicalTrials.gov Identifier: NCT02021916
Recruitment Status : Unknown
Verified December 2013 by Robert C. Martin, University of Louisville.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

Study Description
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Brief Summary:
To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.

Condition or disease
Normal and Abnormal Tissue

Detailed Description:
The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.
Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Louisville Cooperative Tissue Biorepository of the James Graham Brown Cancer Center Tissue Collection Consent
Study Start Date : July 2005
Estimated Primary Completion Date : January 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. [ Time Frame: 15 Years ]

Biospecimen Retention:   Samples With DNA
Collection of normal or abnormal tissue at the time of surgery from consented subjects. Collection of blood and urine the day of consent or day of surgery.

Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing surgery for removal of normal or abnormal tissues that are removed from the human body as part of standard medical and surgical practice at the University of Louisville Hospital, Norton Hospital downtown, Jewish Hospital downtown and Kosair Children's Hospital.
Criteria

Inclusion Criteria:

  • Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice

Exclusion Criteria:

  • Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.
Contacts and Locations
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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): NCT02021916


Contacts
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Contact: Robert Martin, M.D., Ph.D. 502-629-3355 robert.martin@louisville.edu

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Robert Martin, M.D., Ph.D.    502-629-3355    robert.martin@louisville.edu   
Principal Investigator: Robert Martin, M.D., Ph.D.         
Sponsors and Collaborators
University of Louisville
Investigators
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Principal Investigator: Robert Martin, MD, PhD University of Louisville
More Information
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Responsible Party: Robert C. Martin, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT02021916    
Other Study ID Numbers: 397.05
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: December 2013