MelanomaNCT00889980
Melanoma Molecular Profiling Analysis
An observational study of Melanoma, run by University of Pittsburgh at 1 site in United States.
Trial summary
There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Biospecimen banking
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 22 Jul 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Melanoma patients
Who may be able to join
- Primary melanoma with the following Breslow thickness and stage
- ≥ 2 mm with ulceration, T3b
- ≥ 4 mm without (T4a) or with (T4b) ulceration
- Patients with a biopsied tumor that has not been widely resected will also be eligible for study according to the above-specified criteria for tumor thickness and stage.
- Age 12 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
- Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.
Who cannot join
- Serious illnesses that may be considered a contraindication to surgery as determined by the physician investigator. If a subject is cleared for surgery as clinically indicated (wide excision of the primary melanoma and sentinel lymph node biopsy), subject would be eligible.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study
- Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis
There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. Material only from already-indicated and planned procedures as part of standard medical care will be used. The main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.
- Conditions
- Melanoma
- Being tested
- Biospecimen banking
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen bankingOther
SLN and one non-SLN (8mm and larger in longest dimension). fourteen 10cc tubes or a total of 140mL of blood will be collected from subjects weighing over 102.6 pounds. If the subject weighs less than 102.6 pounds, the amount of blood drawn will be based on exact body weight. The amount of blood drawn will be no more than 3mL/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma | Patients with primary melanoma Receives: Other: Biospecimen banking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecularly characterize the regional nodal status of positive and negative SLNs (SLN+ and SLN-) in patients undergoing SLN mapping and dissection for routine staging of melanoma.
Measured: 2 years
Secondary outcomes (1)
Biomarkers differentially expressed between SLN+ and SLN- specimens, molecular profiling the SLN+ node and adjacent non-SLN, and if association exists between specific gene signatures for positive and negative SLN and clinical outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2008
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Principal investigator, John Kirkwood, University of Pittsburgh
- Investigators
- Ahmad Tarhini, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889980
- Sponsor's protocol ID
- 07-133
- Status last verified
- Jun 2020
- First submitted
- 28 Apr 2009
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node and Non-Sentinel Lymph Nodes (SLN and Non-SLN) Procurement From Melanoma Subjects for Molecular Profiling Analysis
- ClinicalTrials.gov ID
- NCT00889980
- Acronym / sponsor ID
- 07-133
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- May 2008
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 29 Apr 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.
There is a significant need to develop new and more effective ways to treat melanoma that will decrease patient morbidity and mortality. This protocol intends to collect and process a portion (< 20% of any node) of lymph nodes from melanoma patients undergoing routine surgical SLN resection: the SLN(s) and 1 adjacent non-SLN(s) are planned for study. In addition, blood will be drawn at the pre study visit (serum and peripheral blood mononuclear cells) and appropriate lineage control tissue will be collected. Material only from already-indicated and planned procedures as part of standard medical care will be used. The main goal of this study will be to properly collect and process material to be analyzed and explore the molecular features melanoma biological samples.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma | – | Other: Biospecimen bankingPatients with primary melanoma |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Melanoma patients
Key inclusion criteria (7 listed)
- Primary melanoma with the following Breslow thickness and stage
- Age 12 years or older.
- Patients must have documented hemoglobin level of 10g/dL or higher. This can be drawn on the day of consent, or be documented from a previous visit within the past 30 days
- Subjects must have provided written, informed consent prior to any study procedures: collection of blood and LN tissue specimens for this protocol.
Key exclusion criteria (4 listed)
- Serious illnesses that may be considered a contraindication to surgery as determined by the physician investigator. If a subject is cleared for surgery as clinically indicated (wide excision of the primary melanoma and sentinel lymph node biopsy), subject would be eligible.
- Any significant psychiatric disease, medical intervention, or other condition, which in the opinion of the Principal Investigator or Co-Investigators, could prevent adequate informed consent or compromise participation in the clinical trial.
- Active infection or antibiotics within one-week prior to study
- Systemic steroid or other immunosuppressive therapy administered for more than 10 days within 4 weeks of enrollment.
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 |
|---|---|---|
| Biospecimen bankingSLN and one non-SLN (8mm and larger in longest dimension). fourteen 10cc tubes or a total of 140mL of blood will be collected from subjects weighing over 102.6 pounds. If the subject weighs less than 102.6 pounds, the amount of blood drawn will be based on exact body weight. The amount of blood drawn will be no more than 3mL/kg of body weight. | Other | Melanoma |
Primary outcome
Molecularly characterize the regional nodal status of positive and negative SLNs (SLN+ and SLN-) in patients undergoing SLN mapping and dissection for routine staging of melanoma.
Time frame: 2 years
1 secondary outcome
Biomarkers differentially expressed between SLN+ and SLN- specimens, molecular profiling the SLN+ node and adjacent non-SLN, and if association exists between specific gene signatures for positive and negative SLN and clinical outcomes.
Time frame: 2 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 9 Jun 2020.
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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.
Ahmad Tarhini, MD principal investigator
University of Pittsburgh Medical 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, run by University of Pittsburgh 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 7 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: finished, as of the sponsor's last update on 9 Jun 2020. 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 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?
Molecularly characterize the regional nodal status of positive and negative SLNs (SLN+ and SLN-) in patients undergoing SLN mapping and dissection for routine staging of melanoma. (time frame: 2 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 9 Jun 2020.