Tissue Procurement for Biomedical Research

Normal Volunteers Clinical Trial

Official title:

Tissue Procurement for Biomedical Research

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00182858
• Other study ID #: 999903322
• Secondary ID: 03-AG-N322
• Status: Recruiting
• Start date: June 26, 2003
• Est. completion date: December 31, 2028

Study information

• Verified date: May 20, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Denise L Melvin, R.N.
• Phone: (410) 350-3924
• Email: melvinde[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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....

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.

Other known NCT identifiers

• NCT01927796

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Normal Volunteers

Locations

Country	Name	City	State
United States	National Institute of Aging, Clinical Research Unit	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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