NCT Number: NCT00898183
S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This laboratory study is assessing genes and immune response in tumor samples from patients with locally advanced or metastatic melanoma.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
polymorphism analysis
GeneticPrimary outcomes
-
Correlation of frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases with clinical outcome
-
Correlation of frequency of specific genetic alterations at either the DNA, mRNA, or protein level with clinical outcome
-
Host immunologic response to metastatic melanoma (i.e., in vivo pattern of cytokine expression consistent with specific subsets of T helper cells within melanoma deposits)
-
Variation and correlation of host immunologic response with site of metastatic disease and/or clinical outcome
-
Development of a tissue bank (peripheral blood, sera, and paraffin-embedded tumor blocks)
-
Correlation of the most prevalent gene copy alteration observed in metastatic disease with the risk of progression
Sponsors and collaborators
Lead sponsor
SWOG Cancer Research Network
Network
Collaborators
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
Registry information
Official study title
Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary
Important dates
- Study start
- 1996
- Primary completion
- 2006
- Study completion
- 2007
- First posted
- May 12, 2009
- Registry last updated
- Jun 28, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Nivolumab in Treating Patients With Stage IIB-IIC Melanoma That Can Be Removed by Surgery
NCT03405155
Melanoma, Melanoma (Skin)
New Brunswick, New Jersey, United States
View Trial DetailsDermoscopy Augmented Histology Trial, Consensus Agreement Diagnosis Made by Dermatopathology Experts
NCT05712551
Melanoma, Melanoma (Skin)
Herlev, Denmark
View Trial DetailsNew Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy
NCT03136783
Melanoma, Melanoma (Skin)
Amiens, Picardie, France
View Trial DetailsCryotherapy With in Situ Immunotherapy in Melanoma Metastasis
NCT03949153
Melanoma, Melanoma (Skin)
Strasbourg, France
View Trial Details