Tissue Procurement for Biomedical Research
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| ClinicalTrials.gov Identifier: NCT00182858 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2005
Last Update Posted : May 26, 2023
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| Tracking Information | |||||||||
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| First Submitted Date | September 12, 2005 | ||||||||
| First Posted Date | September 16, 2005 | ||||||||
| Last Update Posted Date | May 26, 2023 | ||||||||
| Actual Study Start Date | June 26, 2003 | ||||||||
| Estimated Primary Completion Date | December 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Not Provided | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Tissue Procurement for Biomedical Research | ||||||||
| Official Title | Tissue Procurement for Biomedical Research | ||||||||
| 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. |
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| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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| 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 | 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.
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
5000 | ||||||||
| Original Enrollment | Same as current | ||||||||
| Study Completion Date | December 31, 2028 | ||||||||
| Estimated Primary Completion Date | December 31, 2028 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
EXCLUSION CRITERIA:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT00182858 | ||||||||
| Other Study ID Numbers | 999903322 03-AG-N322 |
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| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Not Provided | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | National Institute on Aging (NIA) | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | February 3, 2023 | ||||||||