Normal and Abnormal TissueLCTBNCT02021916
Louisville Cooperative Tissue Biorepository
An observational study of Normal and Abnormal Tissue, run by University of Louisville at 1 site in United States.
Trial summary
To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Normal and Abnormal Tissue
- How many people
- 17,499 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to 11 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery for removal of normal or abnormal tissues that are removed from the human body as part of standard medical and surgical practice at the University of Louisville Hospital, Norton Hospital downtown, Jewish Hospital downtown and Kosair Children's Hospital.
Who may be able to join
- Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice
Who cannot join
- Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Louisville Cooperative Tissue Biorepository of the James Graham Brown Cancer Center Tissue Collection Consent
To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.
Read the detailed description
The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.
- Conditions
- Normal and Abnormal Tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made.
Measured: 15 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJul 2005
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal and Abnormal TissueStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 17,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert C. Martin, University of Louisville
- Investigators
- Robert Martin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021916
- Sponsor's protocol ID
- 397.05
- Acronym
- LCTB
- Status last verified
- Nov 2021
- First submitted
- 20 Dec 2013
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Louisville Cooperative Tissue Biorepository of the James Graham Brown Cancer Center Tissue Collection Consent
- ClinicalTrials.gov ID
- NCT02021916
- Acronym / sponsor ID
- LCTB / 397.05
- Conditions
- Normal and Abnormal Tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,499 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jul 2005 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide appropriate collection, storage, and distribution of specimens and medical data to local investigators who have approved IRB protocols for their specific research purposes.
Detailed description
The mission of the Louisville Cooperative Tissue Biorepository is to appropriately collect normal and abnormal tissues that are removed from the human body as a part of standard medical and surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. The LCTB securely stores appropriately collected human samples for research purposes and appropriately allocates these samples to local investigators for research purposes. The LCTB team appropriately documents all points in the process of obtaining informed consent, collection, storage, and allocation of tissues.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery for removal of normal or abnormal tissues that are removed from the human body as part of standard medical and surgical practice at the University of Louisville Hospital, Norton Hospital downtown, Jewish Hospital downtown and Kosair Children's Hospital.
Key inclusion criteria (1 listed)
- Patients undergoing surgery for removal or normal and abnormal tissues as part of standard medical and surgical practice
Key exclusion criteria (1 listed)
- Patients with known systematic infections including septic patients with bacterial and viral infections, hepatitis, HIV, TB and other defined pathogens will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made.
Time frame: 15 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
Related trials for Normal and Abnormal Tissue
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging
Normal and Abnormal Cardiovascular Physiology
Not yet recruitingObservational study
SLNB Combined With WLNB for Axillary De-escalation in Breast Cancer Patients With Abnormal Axillary Nodes
Breast Cancer
Active, not recruitingObservational study
Heidelberg Engineering ANTERION Software Comparison Study
Eyes With Normal Anterior Segment, Eyes With Abnormal Anterior Segment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Martin, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal and Abnormal Tissue, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect normal and abnormal tissues that are removed from the human body as a part of standard surgical practice after adequate portions are secured by surgical pathologists to allow for correct diagnoses to be made. (time frame: 15 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.