Tissue Procurement for Biomedical Research

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 Overview

• Status: Recruiting
• Conditions: Normal Volunteers

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 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Josephine M Egan, M.D.; Phone Number: (410) 558-8414; Email: eganj@mail.nih.gov
• Study Contact Backup: Name: Denise L Melvin, R.N.; Phone Number: (410) 350-3924; Email: melvinde@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • National Institute of Aging, Clinical Research Unit
      • Contact: NIA Studies Recruitment; Phone Number: 410-350-3941; Email: niastudiesrecruitment@mail.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Any healthy volunteer.

Description

• INCLUSION CRITERIA:
• Age 18 or older.
• Identified by the investigator , researcher, 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 generation of hypotheses for future study.
• Healthy volunteers, willing to provide their samples.

EXCLUSION CRITERIA:

• The participant 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 to give informed consent.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Ongoing

Collaborators and Investigators

• Sponsor: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Josephine M Egan, M.D., National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2003
• Primary Completion (Estimated): December 31, 2028
• Study Completion: December 31, 2028

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimated): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: November 20, 2023

More Information

Terms related to this study

• Keywords: Natural History; Tissue Procurement; Biologic Sample Collection
• Other Study ID Numbers: 999903322; 03-AG-N322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .The NIA IRP is discussing the plan to make IPD available. A final decision has not been made.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No