Characterization of the Melanoma-Specific Immune Response

NCT ID: NCT00368615

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

2

Age-matched controls (no evidence of melanoma)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Biopsy diagnosis of malignant melanoma
* Have had a biopsy diagnosis of malignant melanoma in the past

Exclusion Criteria

* Patients taking immunosuppressive medications
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emanual Maverakis, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis Department of Dermatology

Sacramento, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emanual Maverakis, M.D.

Role: CONTACT

916-734-1267

Lauren Downing

Role: CONTACT

916-551-2635

Facility Contacts

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Emanual Maverakis, M.D.

Role: primary

916-734-6556

Lauren Downing

Role: backup

916-551-2635

Related Links

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http://www.ucdmc.ucdavis.edu/dermatology/research/clinical

University of California-Davis Department of Dermatology Clinical Research

Other Identifiers

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362163

Identifier Type: -

Identifier Source: org_study_id

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