Melanoma (Skin)NCT00049010
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
A study testing comparative genomic hybridization, cytogenetic analysis and fluorescence in situ hybridization in people with Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 27 sites in United States.
Trial summary
RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer. 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?
- comparative genomic hybridization, cytogenetic analysis and fluorescence in situ hybridization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 27 sitesUnited States
- Study dates
- Sep 2002to Oct 2009
- Phase
- Interventional
- 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
- Histologically documented primary AJCC stage I or II melanoma. Evidence of ulceration, vertical growth phase, regression, lymphocytic infiltration, vascular invasion, microscopic satellitosis, and mitotic rate shall be noted.
- Patients planning to undergo a sentinel lymph node biopsy, or an elective lymph node dissection of an anatomic draining region from the index primary melanoma.
- ≥18 years of age
- Patients must be registered prior to planned surgery. The surgery must be performed within 45 days following registration.
- No concurrent active malignancy other than carcinoma in situ of the cervix and basal cell carcinoma of the skin, or history of any other primary malignancy including previously primary melanoma.
- Tissue blocks: one of primary tumor tissue taken from region of greatest Breslow thickness. Note: If blocks cannot be sent due to institutional policy, slides may be substituted for the locks per the protocol.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Mountainview Medical
Berlin Corners, Vermont, 05602
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, 52402
St. Luke's Hospital
Cedar Rapids, Iowa, 52402
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Roper St. Francis Cancer Center at Roper Hospital
Charleston, South Carolina, 29401
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Danville Regional Medical Center
Danville, Virginia, 24541
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534
Capital Region Cancer Center
Jefferson City, Missouri, 65101
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, 03431
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, 55455
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Rhode Island Hospital
Providence, Rhode Island, 02903
Miriam Hospital at Lifespan
Providence, Rhode Island, 02906
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, 13057
Community General Hospital of Greater Syracuse
Syracuse, New York, 13215
Wilson Medical Center
Wilson, North Carolina, 27893-3428
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
Commonwealth Hematology-Oncology P.C. - Worcester
Worcester, Massachusetts, 01605
About this study
Official title: Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
RATIONALE: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.
Read the detailed description
OBJECTIVES:
- Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
- Correlate melastatin expression prospectively with event-free survival of these patients.
OUTLINE: This is a multicenter study.
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.
- Conditions
- Melanoma (Skin)
- Being tested
- comparative genomic hybridization, cytogenetic analysis, fluorescence in situ hybridization, immunohistochemistry staining method
- Keywords
- stage I melanoma, stage II melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparative genomic hybridizationGenetic
cytogenetic analysisGenetic
fluorescence in situ hybridizationGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years. Receives: Genetic: comparative genomic hybridization; Genetic: cytogenetic analysis; Genetic: fluorescence in situ hybridization; Other: immunohistochemistry staining method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Measured: Up to 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionMar 2006
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- F. Stephen Hodi, MD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049010
- Sponsor's protocol ID
- CALGB-500105
- Other IDs
- U10CA031946, CALGB-500105, CDR0000257230
- Status last verified
- Jun 2016
- First submitted
- 12 Nov 2002
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Melastatin Expression in Predicting the Risk for Developing Local Regional Metastases of Primary Melanoma
- ClinicalTrials.gov ID
- NCT00049010
- Acronym / sponsor ID
- CALGB-500105
- Conditions
- Melanoma (Skin)
- Keywords
- stage I melanoma, stage II melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Mar 2006 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Jan 2003 (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: Diagnostic procedures that analyze surgically-removed tumor tissue and lymph node samples may help doctors identify patients with melanoma who are at risk for developing metastatic cancer.
PURPOSE: This clinical trial is studying tumor tissue and lymph node samples to see how well they work in predicting the development of metastatic cancer in patients with stage I or stage II melanoma.
Detailed description
OBJECTIVES:
- Correlate degree of melastatin gene expression with risk of developing local regional metastases in patients with primary stage I or II melanoma.
- Correlate melastatin expression prospectively with event-free survival of these patients.
OUTLINE: This is a multicenter study.
Melastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy.
Patients are followed every 4 months for 3.5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study within 3.5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Genetic: comparative genomic hybridization, Genetic: cytogenetic analysis, Genetic: fluorescence in situ hybridization, Other: immunohistochemistry staining methodMelastatin mRNA expression is determined by in situ hybridization using tissue from primary tumor and lymph nodes. Tissue is also examined by immunohistochemical staining using antibodies to S-100 and MART-1. Patients do not receive the results of these tests nor do the results influence individual therapy. Patients are followed every 4 months for 3.5 years. |
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 |
|---|---|---|
| comparative genomic hybridization | Genetic | Group 1 |
| cytogenetic analysis | Genetic | Group 1 |
| fluorescence in situ hybridization | Genetic | Group 1 |
| immunohistochemistry staining method | Other | Group 1 |
Primary outcome
Relapse-free survival
Time frame: Up to 3.5 years
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 1 Jul 2016.
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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.
F. Stephen Hodi, MD study chair
Dana-Farber Cancer Institute
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparative genomic hybridization, cytogenetic analysis and fluorescence in situ hybridization in people with Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 27 sites in United States.
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 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Relapse-free survival (time frame: Up to 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2016.