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Gerontology Research Center Tissue Procurement for Biomedical Research

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ClinicalTrials.gov Identifier: NCT00182858
Recruitment Status : Recruiting
First Posted : September 16, 2005
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 16, 2005
Last Update Posted Date February 26, 2019
Actual Study Start Date February 10, 2003
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2019)
Provide the investigators the opportunity to obtain tissues for laboratory evaluation with the goal of either better understanding a disease or design a scientific study to better understand or treat a disease [ Time Frame: Ongoing ]
The goal is to assist in either the better understanding of a disease or to design a scientific study to better understand or treat a disease.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00182858 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gerontology Research Center Tissue Procurement for Biomedical Research
Official Title Tissue Procurement for Biomedical Research
Brief Summary

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.

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 including: blood, urine, saliva, sweat, feces, and hair and nail clippings. It may also include samples taken during a surgical procedure, including: fluid from around the spinal column, heart, lungs and abdomen; fat, muscle, connective tissue and organs (liver, bladder, heart, kideny and skin).

Information derived from such studies is for research purposes only and is not provided to the patient/subject or their health care provider. Samples will be coded (no names) and identifying information linking the particpinat to the sample will be maintained in s secure location by the P.I. and Study Coordinator.

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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Any healthy volunteer
Condition Normal Volunteers
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 12, 2005)
5000
Original Enrollment Same as current
Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Josephine M Egan, M.D. (410) 558-8414 eganj@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00182858
Other Study ID Numbers 999903322
03-AG-N322
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
Study Sponsor National Institute on Aging (NIA)
Collaborators Not Provided
Investigators
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 21, 2019