Melanoma (Skin)NCT00991991
Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma
An observational study of Melanoma (Skin), run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- gene expression analysis, polymerase chain reaction and polymorphism analysis
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Mar 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Primary care clinic
Who may be able to join
- Node positive Group (experimental group)
- Primary melanoma > 2 mm in depth
- Metastasis must be > 0.1 mm and detectable by IHC or hematoxylin and eosin (H\&E) to be considered node positive
- Slides and block for primary and node must be archived in UH dermatopathology
- Node Negative Group (control group)
- Primary melanoma > 2 mm in depth
Show all 13Show fewer
- A negative sentinel lymph node must be negative by IHC and H\&E
- No stage IV disease
- No acral and mucosal histology
- No history of prior invasive melanoma
- Underwent primary excision and sentinel lymph node biopsy within 3 months of each other
- Archived tissue available
- Slides and block for primary tumor and node biopsy must be archived in University Hospitals Case Medical Center (UH) dermatopathology
Who cannot join
- Acral and mucosal histology
- Previous diagnosis of invasive melanoma
- previous chemotherapy or immunotherapy
- patients who are found to have stage IV disease during workup
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma.
Read the detailed description
OBJECTIVES:
- Determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for 1) activating mutations B-Raf and N-Ras associated with melanoma development, and 2) allelic imbalances across the genome.
- Compare the genetic profile of primary melanomas from patients with and without lymph node involvement.
- Determine the combinations of genetic lesions that correlate with nodal metastasis by adopting a statistical machine learning approach to build a lesion-based classifier for nodal metastasis.
OUTLINE: Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases.
- Conditions
- Melanoma (Skin)
- Being tested
- gene expression analysis, polymerase chain reaction, polymorphism analysis, matrix-assisted laser desorption/ionization time of flight mass spectrometry, medical chart review
- Keywords
- stage I melanoma, stage II melanoma, stage III 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
Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
polymerase chain reactionGenetic
Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
polymorphism analysisGenetic
Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
matrix-assisted laser desorption/ionization time of flight mass spectrometryOther
Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
medical chart reviewOther
Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
Measured: at the time of presentation
Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
Measured: at the time of presentation
Combinations of genetic lesions that correlate with nodal metastasis
Measured: at the time of presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Not enough tissue for analysis
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 Case Comprehensive Cancer CenterThe 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
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Henry Koon, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991991
- Sponsor's protocol ID
- CASE1609
- Other IDs
- P30CA043703, CASE1609, CASE 1609-CC733
- Status last verified
- May 2016
- First submitted
- 7 Oct 2009
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genomic Lesions Promoting Nodal Metastasis in Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00991991
- Acronym / sponsor ID
- CASE1609
- Conditions
- Melanoma (Skin)
- Keywords
- stage I melanoma, stage II melanoma, stage III melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough tissue for analysis
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Oct 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 the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma.
Detailed description
OBJECTIVES:
- Determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for 1) activating mutations B-Raf and N-Ras associated with melanoma development, and 2) allelic imbalances across the genome.
- Compare the genetic profile of primary melanomas from patients with and without lymph node involvement.
- Determine the combinations of genetic lesions that correlate with nodal metastasis by adopting a statistical machine learning approach to build a lesion-based classifier for nodal metastasis.
OUTLINE: Laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed.
Information about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tumor tissue samples from patients with stage I, stage II, or stage III malignant melanoma. Primary care clinic
Key inclusion criteria (13 listed)
- Node positive Group (experimental group)
- Node Negative Group (control group)
Key exclusion criteria (4 listed)
- Acral and mucosal histology
- Previous diagnosis of invasive melanoma
- previous chemotherapy or immunotherapy
- patients who are found to have stage IV disease during workup
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 analysisLaser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed. | Genetic | – |
| polymerase chain reactionLaser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed. | Genetic | – |
| polymorphism analysisLaser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed. | Genetic | – |
| matrix-assisted laser desorption/ionization time of flight mass spectrometryLaser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. DNA is then purified from the samples and amplified using PCR. Matrix-assisted laser desorption/ionization (MALDI)-time of flight mass spectrometry technology is used to detect mutations of B-Raf and N-Ras. Single nucleotide polymorphism arrays are also performed. | Other | – |
| medical chart reviewInformation about the patient's demographics (e.g., TNM staging, sex, age, and tissue collection dates) will be gathered by chart review or from the Multidisciplinary Melanoma Conference at University Hospitals tumor conference report in order to match cases. | Other | – |
Primary outcome
Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
Time frame: at the time of presentation
Comparison of genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement
Time frame: at the time of presentation
Combinations of genetic lesions that correlate with nodal metastasis
Time frame: at the time of presentation
Results and safety
The study was stopped early (reason given: Not enough tissue for analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 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.
Henry Koon, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin), run by Case Comprehensive Cancer Center at 1 site 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?
The sponsor lists 13 inclusion and 4 exclusion criteria. 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: stopped early, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Not enough tissue for analysis). Results are not available in the source record.
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?
Genetic profile of patients with primary melanomas with and without synchronous regional nodal involvement (time frame: at the time of presentation). The study lists 3 primary outcomes in all. 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 17 May 2016.