Tissue Procurement for Biomedical Research

NCT ID: NCT00182858

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-26
• Study Completion Date: 2028-12-31

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....

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.

Conditions

Normal Volunteers

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: lead

Principal Investigators

Josephine M Egan, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Locations

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Denise L Melvin, R.N.

Role: CONTACT

melvinde@mail.nih.gov

(410) 350-3924

Josephine M Egan, M.D.

Role: CONTACT

eganj@mail.nih.gov

(410) 558-8414

Facility Contacts

NIA Studies Recruitment

Role: primary

niastudiesrecruitment@mail.nih.gov

410-350-3941

Other Identifiers

03-AG-N322

Identifier Type: -

Identifier Source: secondary_id

999903322

Identifier Type: -

Identifier Source: org_study_id

NCT01927796

Identifier Type: -

Identifier Source: nct_alias