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Gerontology Research Center Tissue Procurement for Biomedical Research

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00182858
First received: September 12, 2005
Last updated: March 22, 2016
Last verified: March 2016
  Purpose

The need to obtain human tissue (blood, urine, saliva, sweat, pleural, pericardia\, ascitic, synovial, cerebrospinal fluids) for methods development and disease correlation is frequent in Gerontology Research Center laboratories. This protocol is to create the opportunity to obtain such tissue samples that have been obtained during the course of usual clinical care and would be discarded, or alternatively, to obtain such samples during subject and patient screening for other studies (in this case only blood, urine, saliva, or sweat). Information derived from such studies is for research purposes only and is not provided to the patient/subject or their health care provider. When genetic analyses are performed, samples will have been coded and identifying information linking patient/subject to the sample will be destroyed. Any genetic information obtained will have no established clinical value and will not be provided to the subject/patient or their health care provider.

Patients included will be those 18 years or older and who have been identified by the investigator to have a condition of interest for exploratory studies related to the patient's illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Patients will be excluded if obtaining the sample would be over and above usual clinical care, would result in excessive blood loss, or the individual is unable to provide informed consent.

The expected outcome is to provide the investigator the opportunity to obtain tissues of interest for laboratory evaluation with the goal of either better understanding a disease or to design a scientific study to better understand or treat a disease.


Condition
Tissue Procurement

Study Type: Observational
Official Title: Tissue Procurement for Biomedical Research

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Exploratory studies for methods development and disease correlations [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: February 2003
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Detailed Description:

The need to obtain human tissue (blood, urine, saliva, sweat, pleural, pericardial, ascitic, synovial, cerebrospinal fluids) for methods development and disease correlation is frequent in Gerontology Research Center laboratories. This protocol is to create the opportunity to obtain such tissue samples that have been obtained during the course of usual clinical care and would be discarded, or alternatively, to obtain such samples during subject and patient screening for other studies (in this case only blood, urine, saliva, or sweat).

Information derived from such studies is for research purposes only and is not provided to the patient/subject or their health care provider. When genetic analyses are performed, samples will have been coded and identifying information linking patient/subject to the sample will be destroyed. Any genetic information obtained will have no established clinical value and will not be provided to the subject/patient or their health care provider.

Patients included will be those 18 years or older and who have been identified by the investigator to have a condition of interest for exploratory studies related to the patient s illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Patients will be excluded if obtaining the sample would be over and above usual clinical care, would result in excessive blood loss, or the individual is unable to provide informed consent.

The expected outcome is to provide the investigator the opportunity to obtain tissues of interest for laboratory evaluation with the goal of either better understanding a disease or to design a scientific study to better understand or treat a disease.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Age 18 or older.
  • Identified by the investigator to have a condition of interest for exploratory studies related to the patient s illness or other feature that offers the possibility of generation of hypotheses for future study.

EXCLUSION CRITERIA:

  • The patient would be subjected to diagnostic and/or therapeutic procedures that are not necessary for clinical management.
  • Excessive blood loss if this phlebotomy plus other research participation and/or clinical evaluation will result in blood loss of greater than 1 unit (400 ml, 1 pint) over an 8-week period.

Inability of the volunteer to give 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: NCT00182858

Contacts
Contact: Josephine M Egan, M.D. (410) 558-8414 eganj@mail.nih.gov

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
National Institute of Aging, Clinical Research Unit Recruiting
Baltimore, Maryland, United States, 21224
Harbor Hospital Center Recruiting
Baltimore, Maryland, United States
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
  More Information

Responsible Party: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00182858     History of Changes
Obsolete Identifiers: NCT01927796
Other Study ID Numbers: 999903322  03-AG-N322 
Study First Received: September 12, 2005
Last Updated: March 22, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue
Procurement
Exploratory Methods
Disease Correlation
Sampling

ClinicalTrials.gov processed this record on September 23, 2016