KeloidNCT01425437
Keloid Tissue Bank
An observational study of Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
Trial summary
Much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. This trial intends to collect samples of keloid tissue from patients and study them in laboratory. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Keloid
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with a clinical diagnosis of keloid who are 13 years or older.
Who may be able to join
- Patients must have clinically confirmed diagnosis of keloid
- Signed consent form; parent or a legal guardian should consent for children and those under age of 18.
- Have at least one paraffin block of excess keloid tissue that has been removed in the past; or is planned to be removed in future.
- Able and willing to undergo a keloid biopsy (optional)
- Able and willing to undergo biopsy of their normal appearing skin (optional, minimum age 18).
Who cannot join
- Individuals who are mentally challenged, who cannot consent to participate in this study.
- Psychological Illness that may result in non-compliance with the procedure and the required follow up.
- Known allergy to lidocaine or other local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keloid Tissue Bank - Longitudinal Clinical Data Repository; A Genomic and Molecular Research to Identifying Molecular Markers and Signal Transduction Pathways in Keloid; and Correlations With the Natural History of the Disease.
Much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. This trial intends to collect samples of keloid tissue from patients and study them in laboratory. Such a research may help us with finding better treatments for keloid.
Read the detailed description
To aims of this trial are:
- To prospectively collect keloid and normal skin tissue samples from patients with keloid by performing keloid tissue biopsy and biopsy of uninvolved skin.
- To collect blood and/or saliva for genomics, proteomics, tissue culture, flow cytometery and other keloid investigational studies.
- To collect any keloid tissue that has been previously removed from the patient (unrelated to enrollment on this study).
- To prospectively collect keloid tissue from patients who are undergoing a planned surgical removal of their keloids.
- To evaluate keloid histology, genomics, proteomics, molecular markers, cytokines, growth factors receptors, ligands and signal transduction pathways within keloid tissue in order to find druggable targets.
- To prospectively follow the patients and correlate patient demographics and natural history of the disease, response to the past and future treatments with the genomic and molecular maker profiles.
- To culture nucleated blood cells from keloid patients in order to determine the genomics of this disease as well as learning about potential presence of keloid stem cell in peripheral blood. To use flow cytometry as well as other technology to search for circulating keloid stem cells in peripheral blood.
- To test in vitro:
A- The effect of small molecule kinase inhibitors on the activation of wild-type and mutant kinases.
B- The effects of various drugs that inhibit ligands, receptors or pathways.
- Conditions
- Keloid
- Keywords
- Keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with keloid | All patients will have a clinical diagnosis of keloid and will consent to participate in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases with a genetic mutations within the study cohort will be measured.
Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Poor Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirgan, Michael H., M.D.
- Responsible party
- Sponsor
- Investigators
- Michael H Tirgan, MD, Study chair, Keloid Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425437
- Sponsor's protocol ID
- Tirgan 11-02
- Status last verified
- Nov 2014
- First submitted
- 23 Aug 2011
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keloid Tissue Bank - Longitudinal Clinical Data Repository; A Genomic and Molecular Research to Identifying Molecular Markers and Signal Transduction Pathways in Keloid; and Correlations With the Natural History of the Disease.
- ClinicalTrials.gov ID
- NCT01425437
- Acronym / sponsor ID
- Tirgan 11-02
- Conditions
- Keloid
- Keywords
- Keloid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor Enrollment
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Tirgan, Michael H., M.D.
- Study start
- Jun 2012
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 30 Aug 2011 (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.
Much progress in treatment of various tumors has been made in the laboratory and the results have been brought back to the patients, i.e. from bench to bedside. This trial intends to collect samples of keloid tissue from patients and study them in laboratory. Such a research may help us with finding better treatments for keloid.
Detailed description
To aims of this trial are:
- To prospectively collect keloid and normal skin tissue samples from patients with keloid by performing keloid tissue biopsy and biopsy of uninvolved skin.
- To collect blood and/or saliva for genomics, proteomics, tissue culture, flow cytometery and other keloid investigational studies.
- To collect any keloid tissue that has been previously removed from the patient (unrelated to enrollment on this study).
- To prospectively collect keloid tissue from patients who are undergoing a planned surgical removal of their keloids.
- To evaluate keloid histology, genomics, proteomics, molecular markers, cytokines, growth factors receptors, ligands and signal transduction pathways within keloid tissue in order to find druggable targets.
- To prospectively follow the patients and correlate patient demographics and natural history of the disease, response to the past and future treatments with the genomic and molecular maker profiles.
- To culture nucleated blood cells from keloid patients in order to determine the genomics of this disease as well as learning about potential presence of keloid stem cell in peripheral blood. To use flow cytometry as well as other technology to search for circulating keloid stem cells in peripheral blood.
- To test in vitro:
A- The effect of small molecule kinase inhibitors on the activation of wild-type and mutant kinases.
B- The effects of various drugs that inhibit ligands, receptors or pathways.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with keloid | – | –All patients will have a clinical diagnosis of keloid and will consent to participate in this study. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with a clinical diagnosis of keloid who are 13 years or older.
Key inclusion criteria (5 listed)
- Patients must have clinically confirmed diagnosis of keloid
- Signed consent form; parent or a legal guardian should consent for children and those under age of 18.
- Have at least one paraffin block of excess keloid tissue that has been removed in the past; or is planned to be removed in future.
- Able and willing to undergo a keloid biopsy (optional)
- Able and willing to undergo biopsy of their normal appearing skin (optional, minimum age 18).
Key exclusion criteria (3 listed)
- Individuals who are mentally challenged, who cannot consent to participate in this study.
- Psychological Illness that may result in non-compliance with the procedure and the required follow up.
- Known allergy to lidocaine or other local anesthetics.
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
Percentage of cases with a genetic mutations within the study cohort will be measured.
Time frame: Three years
Prevalence of various biomarkers and/or mutations will be determined and co-related with the clinical presentation of the disease.
Results and safety
The study was stopped early (reason given: Poor Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
Michael H Tirgan, MD study chair
Keloid Research Foundation
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 Keloid, run by Tirgan, Michael H., M.D. 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 18 Nov 2014. 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 was stopped early (reason given: Poor Enrollment). Results are not available in the source record.
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?
Percentage of cases with a genetic mutations within the study cohort will be measured. (time frame: Three 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 18 Nov 2014.