Melanoma (Skin)NCT00898183
S9431: Studying Genes and Immune Response in Tumor Samples From Patients With Locally Advanced or Metastatic Melanoma
An observational study of Melanoma (Skin), run by SWOG Cancer Research Network.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gene expression analysis and polymorphism analysis
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Nov 1996to Feb 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary
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.
Read the detailed description
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.
- Conditions
- Melanoma (Skin)
- Being tested
- gene expression analysis, polymorphism analysis
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 1996
- Primary completionFeb 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Responsible party
- Sponsor
- Investigators
- David M. Gustin, MD, Study chair, University of ChicagoJohn M. Kirkwood, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898183
- Sponsor's protocol ID
- CDR0000078645
- Other IDs
- SWOG-9431, U10CA032102
- Status last verified
- Feb 2013
- First submitted
- 9 May 2009
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Moore SR, Persons DL, Sosman JA, Bobadilla D, Bedell V, Smith DD, Wolman SR, Tuthill RJ, Moon J, Sondak VK, Slovak ML. Detection of copy number alterations in metastatic melanoma by a DNA fluorescence in situ hybridization probe panel and array comparative genomic hybridization: a southwest oncology group study (S9431). Clin Cancer Res. 2008 May 15;14(10):2927-35. doi: 10.1158/1078-0432.CCR-07-4068.
PubMed 18483359
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytogenetic, Molecular and Cellular Biology Studies in Metastatic Melanoma Patients, Ancillary
- ClinicalTrials.gov ID
- NCT00898183
- Acronym / sponsor ID
- CDR0000078645
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI), Eastern Cooperative Oncology Group
- Study start
- Nov 1996
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 May 2009 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Results publication: PubMed 18483359Moore SR, Persons DL, Sosman JA, Bobadilla D, Bedell V, Smith DD, Wolman SR, Tuthill RJ, Moon J, Sondak VK, Slovak ML. Detection of copy number alterations in metastatic melanoma by a DNA fluorescence in situ hybridization probe panel and array comparative genomic hybridization: a southwest oncology group study (S9431). Clin Cancer Res. 2008 May 15;14(10):2927-35. doi: 10.1158/1078-0432.CCR-07-4068.
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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.
David M. Gustin, MD study chair
University of Chicago
John M. Kirkwood, MD study chair
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of frequency of non-random cytogenetic abnormalities in regional and distant melanoma metastases with clinical outcome. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00898183, which also lists 1 linked publication.
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 28 Jun 2018.