- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00368615
Characterization of the Melanoma-Specific Immune Response (Melanoma)
January 19, 2024 updated by: University of California, Davis
The aim of this study is to study T-cells.
Blood will be collected and the samples will be used to generate T cell clones.
Two separate blood draws will be required at the maximum.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The aim of the study is to in-vitro characterize and expand T cells specific for melanoma-derived antigens.
Peripheral blood with be collected from 20 volunteers with biopsy proven melanoma and 10 age matched controls.
Blood will be collected prior to the initiation of chemotherapy.
There will be no more than two blood draws per patient.
Most patients will receive a single blood draw; however, some participants may be asked to return for a single additional blood draw if investigators were unable to isolate melanoma-specific immune cells after the first blood draw.
Two separate blood draws will be the maximum.
The interval between these blood draws will be a minimum of 3 months apart.
Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing.
After the patient's haplotype has been established melanoma-specific T cell clones will be generated from the peripheral blood samples and expanded in-vitro.
These clones will then be assayed for specificity against commercially available melanoma cell lines.
The T cell clones will also be assayed for reactivity to melanocyte differentiation antigens such as MART-1 and gp100.
If the volunteer requires a palliative resection of a melanoma tumor then the patient's own tumor cells may also be used to test the specificity of the isolated T cell clones.
All experiments will be conducted in-vitro.
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren Downing
- Phone Number: 916-551-2635
- Email: ladowning@ucdavis.edu
Study Contact Backup
- Name: Emanual Maverakis, M.D.
- Phone Number: 916-734-1267
- Email: emaverakis@ucdavis.edu
Study Locations
-
-
California
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Sacramento, California, United States, 95816
- Recruiting
- University of California, Davis Department of Dermatology
-
Contact:
- Lauren Downing
- Phone Number: 916-551-2635
- Email: ladowning@ucdavis.edu
-
Contact:
- Emanual Maverakis, M.D.
- Phone Number: 916-734-6556
- Email: emaverakis@ucdavis.edu
-
Principal Investigator:
- Emanual Maverakis, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects aged 18 years to 85 years who have a biopsy diagnosis of melanoma, and age-matched controls (subjects who do not have a diagnosis of melanoma).
Description
Inclusion Criteria:
- Biopsy diagnosis of malignant melanoma
- Have had a biopsy diagnosis of malignant melanoma in the past
Exclusion Criteria:
- Patients taking immunosuppressive medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
1
Subjects ages 18-85 years old with biopsy proven melanoma.
Peripheral blood will be collected from adults ages 18-85 years old.
These samples will then be used for PCR analysis and to generate melanoma-specific T cell clones.
If the participant requires a palliative resection of a melanoma tumor(s) then tissue from the tumor will be used to characterize the melanoma's interaction with the immune system and to generate melanoma-specific cell lines.
T cell clones isolated from participant's peripheral blood will then be assayed for in-vitro responsiveness to these cell lines.
All experiments will be conducted in-vitro.
|
2
Age-matched controls (no evidence of melanoma)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
melanoma - peripheral blood
Time Frame: 2 Years
|
Peripheral blood will be collected from adults ages 18-85 years old.
These samples will then be used for PCR analysis and to generate melanoma-specific T cell clones.
If the participant requires a palliative resection of a melanoma tumor(s) then tissue from the tumor will be used to characterize the melanoma's interaction with the immune system and to generate melanoma-specific cell lines.
T cell clones isolated from participant's peripheral blood will then be assayed for in-vitro responsiveness to these cell lines.
All experiments will be conducted in-vitro.
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
melanoma - biopsy
Time Frame: 2 Years
|
Patients will not be required to have a biopsy to participate in the study but those who give their consent will undergo a skin biopsy.
The biopsy will be used to characterize the skin-infiltrating inflammatory cells.
The gene-expression profile of these cells will be determined.
Each patient who provides consent will undergo two biopsies, one of lesional skin and the other of normal lesional skin as control.
Patients who develop multiple cutaneous tumors may be reconsented for an additional two biopsies
|
2 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emanual Maverakis, M.D., University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2024
Study Registration Dates
First Submitted
August 24, 2006
First Submitted That Met QC Criteria
August 24, 2006
First Posted (Estimated)
August 25, 2006
Study Record Updates
Last Update Posted (Estimated)
January 23, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 362163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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