Tissue Procurement for Biomedical Research
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| 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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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 |
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| Normal Volunteers |
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 Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Tissue Procurement for Biomedical Research |
| Actual Study Start Date : | June 26, 2003 |
| Estimated Primary Completion Date : | December 31, 2028 |
| Study Completion Date : | December 31, 2028 |
| Group/Cohort |
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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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- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182858
| Contact: Denise L Melvin, R.N. | (410) 350-3924 | dm381j@nih.gov | |
| Contact: Josephine M Egan, M.D. | (410) 558-8414 | eganj@mail.nih.gov |
| United States, Maryland | |
| National Institute of Aging, Clinical Research Unit | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: NIA Studies Recruitment 410-350-3941 niastudiesrecruitment@mail.nih.gov | |
| Principal Investigator: | Josephine M Egan, M.D. | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00182858 |
| Obsolete Identifiers: | NCT01927796 |
| Other Study ID Numbers: |
999903322 03-AG-N322 |
| First Posted: | September 16, 2005 Key Record Dates |
| Last Update Posted: | May 26, 2023 |
| Last Verified: | February 3, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | .The NIA IRP is discussing the plan to make IPD available. A final decision has not been made. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Biologic Sample Collection Tissue Procurement Natural History |