Tissue Procurement for Biomedical Research

Sponsor
National Institute on Aging (NIA) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00182858
Collaborator
(none)
5,000
2
306.2
2500
8.2

Study Details

Study Description

Brief Summary

The need to obtain human tissue for methods development and disease correlation is frequent in Biomedical Research Center laboratories. This protocol is designed to create the opportunity to obtain such tissue samples including: blood, urine, saliva, sweat, feces, hair and nail clippings, nasal scraping, muscle, fat, skin and taste buds. 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, kidney and skin).

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

Participants will be 18 years or older and have been identified by the investigator and/or physician to have a condition of interest for exploratory studies related to the participant s illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Participants could also be healthy volunteers, willing to provide their samples. These samples could be requested by an investigator to be used as age, gender, race and/or ethnicity-matched controls or to calibrate or compare and contrast across lab equipment. Participants 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 investigators with the opportunity to obtain tissues of interest for laboratory evaluation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The need to obtain human tissue for methods development and disease correlation is frequent in Biomedical Research Center laboratories. This protocol is designed to create the opportunity to obtain such tissue samples including: blood, urine, saliva, sweat, feces, hair and nail clippings, nasal scraping, muscle, fat, skin and taste buds. 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, kidney and skin).

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

    Participants will be 18 years or older and have been identified by the investigator and/or physician to have a condition of interest for exploratory studies related to the participant s illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies. Participants could also be healthy volunteers, willing to provide their samples. These samples could be requested by an investigator to be used as age, gender, race and/or ethnicity-matched controls or to calibrate or compare and contrast across lab equipment. Participants 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 investigators with the opportunity to obtain tissues of interest for laboratory evaluation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Tissue Procurement for Biomedical Research
    Actual Study Start Date :
    Jun 26, 2003
    Anticipated Primary Completion Date :
    Dec 31, 2028
    Study Completion Date :
    Dec 31, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Participants will be 18 years or older that are Healthy Volunteers or have been identified by the investigator and/or physician to have a condition of interest for exploratory studies related to the participant s illness or other feature that offers the possibility of creating information that leads to scientifically useful and important studies.

    Outcome Measures

    Primary Outcome Measures

    1. 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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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.

    • Healthy volunteers, willing to provide their samples.

    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

    Locations

    Site City State Country Postal Code
    1 National Institute of Aging, Clinical Research Unit Baltimore Maryland United States 21224
    2 Harbor Hospital Center 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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00182858
    Other Study ID Numbers:
    • 999903322
    • 03-AG-N322
    • NCT01927796
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Aug 19, 2022
    Last Verified:
    Feb 2, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by , ,

    Study Results

    No Results Posted as of Aug 19, 2022