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Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary


N/A
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary


OBJECTIVES:

- Characterize the frequency of non-random cytogenetic abnormalities in regional and
distant melanoma metastases and explore their association with clinical outcome of
patients with metastatic melanoma.

- Characterize the frequency of specific genetic alterations at either the DNA, mRNA, or
protein level and explore the association of these abnormalities with clinical outcome
in these patients.

- Characterize the host immunologic response to metastatic melanoma by determining
whether the in vivo pattern of cytokine expression is consistent with specific subsets
of T helper cells within melanoma deposits and to explore whether host immunologic
response varies based on the site of metastatic disease and/or correlates with clinical
outcome in these patients.

- Obtain peripheral blood, sera, and paraffin embedded tumor blocks from these patients.

- Correlate the most prevalent gene copy alteration observed in metastatic disease with
the risk of progression in tissue samples from patients registered on SWOG-9035
(primary melanoma).

OUTLINE: Fresh and snap frozen tumor tissue samples are obtained from biopsy or surgical
procedures in the coordinated study. Specimens undergo mRNA and DNA analysis of
tumor-related genes and cytokine gene expression. Peripheral blood samples are obtained and
processed for sera and mononuclear cell testing. Tumor tissue samples embedded in paraffin
or on unstained slides are also obtained.

PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 3-4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage III or IV metastatic melanoma

- Concurrent enrollment on a SWOG-coordinated melanoma treatment study (within 56
days of registration on this study) OR

- Previously enrolled on and eligible for at least 1 SWOG-coordinated melanoma
study and scheduled to undergo biopsy/surgery for regional lymph node or
disseminated metastatic disease OR

- Concurrent enrollment on SWOG-9430 (FISH analysis)

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- Not previously enrolled on SWOG-9431

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Correlation of frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases with clinical outcome

Safety Issue:

No

Principal Investigator

David M. Gustin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000078645

NCT ID:

NCT00898183

Start Date:

November 1996

Completion Date:

February 2007

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

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