Metastatic MelanomaNCT01312506
Collection of Cerebrospinal Fluid and Tumor Tissue in Subjects With Metastatic Melanoma and Controls
An observational study of Metastatic Melanoma and CNS Metastases, run by University of Pittsburgh.
Trial summary
This study has two ultimate goals: 1. Understand how the original melanoma from the skin spreads to the CNS. In order to study this we need to collect (and compare) the original skin melanoma, the CNS melanoma, as well as any other melanoma that has not metastasized to the CNS. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metastatic Melanoma, CNS Metastases
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Nov 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are scheduled for craniotomy:
- Histologically confirmed, primary cutaneous melanoma, metastatic to the CNS (brain OR spinal cord OR carcinomatous meningitis) based on:
- Pathologic confirmation (i.e. prior craniotomy) OR
- Radiography (brain MRI or CT scan with intravenous contrast)
- Patients must have no contraindications for and be able to undergo lumbar puncture for CSF collection
- Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable if documented from a previous visit within the prior 30 days
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- Subjects must have provided written, informed consent (ICF) prior to any study procedures
- Subjects must provide a FFPE tissue block containing a biopsy from the primary site
- Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are not having a craniotomy and before they undergo external beam irradiation or stereotactic radiosurgery (patient's and/or neurosurgeon's preference):
- Histologically confirmed melanoma (unknown primary, mucosal, ocular are allowed), metastatic to the CNS (brain OR spinal cord OR carcinomatous meningitis) based on
- Pathologic confirmation (i.e. prior craniotomy) and/or
- Radiography (brain MRI or CT scan with intravenous contrast)
- Patients must have no contraindications for and be able to undergo lumbar puncture for CSF collection
- Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable if documented from a previous visit within the prior 30 days
- Subjects must have provided written ICF prior to any study procedures
- Regarding patients who have distant metastatic melanoma without radiographically detectable melanoma CNS metastases but are willing to undergo lumbar puncture:
- Histologically confirmed melanoma (unknown primary, mucosal, ocular are allowed),
- Patients must have no contraindications to lumbar puncture
- Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent, or will be acceptable, if documented from a previous visit within the prior 30 days
- Subjects must have provided written ICF prior to any study procedures
- Regarding healthy volunteers
- Patients must have no contraindications to lumbar puncture (see Table 1)
- Patient must answer NO to all questions listed in Appendix B
- Hemoglobin level of 8g/dL or higher. This can be drawn on the day of consent or will be acceptable if documented from a previous visit within the prior 30 days
- Subjects must have provided written, ICF prior to any study procedures
Who cannot join
- For study subjects, patients with extradural lesions, i.e. those that originate from the bone (calvarium or vertebrae), will not be considered.
- Any significant psychiatric disease, medical intervention, or other conditions, which in the opinion of the Investigators, could impair proper discussion of the informed consent or compromise participation to the clinical trial.
- Active systemic treatment for metastatic melanoma within 2 days from the collection of specimens (brain tumor tissue, peripheral blood, CSF). Corticosteroids, other immunosuppressive anti-inflammatory and anti-epileptic medications are allowed.
- Patients who have undergone whole brain irradiation therapy within the last 30 days. Therefore neither CNS lesions nor CSF are considered suitable for collection.
- Patients with growing CNS lesions at an area that has previously undergone radiosurgery within 3 months prior to enrollment in this study. Therefore CNS tumors from previously irradiated areas using radiosurgery are not considered suitable for collection although CSF is allowed for collection.
- Brain abscess.
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- Patients with new focal findings on neurological examination.
- Infected skin over the lumbar puncture needle entry site.
- Other conditions that at the opinion of the investigator are contraindicated.
About this study
Official title: Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Serum/Plasma From Patients With Metastatic Melanoma to the CNS and Respective Controls for Gene Expression and Proteomic Profiling
This study has two ultimate goals:
- Understand how the original melanoma from the skin spreads to the CNS. In order to study this we need to collect (and compare) the original skin melanoma, the CNS melanoma, as well as any other melanoma that has not metastasized to the CNS.
- Develop a diagnostic blood test that will early identify subjects at high risk for developing CNS metastasis or patients who may already have CNS metastasis but the MRI or the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from subjects like you who have melanoma CNS metastases in order to confirm the presence of this biomarker.
- Conditions
- Metastatic Melanoma, CNS Metastases
- Keywords
- metastatic, melanoma, CNS
- Medical subject headings
- Melanoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing a craniotomy | This group will include those subjects who have consented to have either a craniotomy or a laminectomy to resect an intramedullary tumor. | |
| Metastases, no craniotomy | These subjects have metastases but have either chosen not to undergo removal of the cancer or their neurosurgeon does not recommend surgical approach or they have been diagnosed with metastatic melanoma but do not have CNS metastases. | |
| Healthy Volunteers | Subjects who do not have known melanoma or metastases. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJul 2012
- Primary completionJul 2012
- Study completionNov 2012
Why it stopped: Trial experienced funding issues, was never opened to accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stergios Moschos, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312506
- Sponsor's protocol ID
- 10-067
- Status last verified
- Jul 2016
- First submitted
- 8 Mar 2011
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procurement of Central Nervous System and Extracranial Tumor Tissues, Cerebrospinal Fluid, and Serum/Plasma From Patients With Metastatic Melanoma to the CNS and Respective Controls for Gene Expression and Proteomic Profiling
- ClinicalTrials.gov ID
- NCT01312506
- Acronym / sponsor ID
- 10-067
- Conditions
- Metastatic Melanoma, CNS Metastases
- Keywords
- metastatic, melanoma, CNS
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Trial experienced funding issues, was never opened to accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Mar 2011 (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.
This study has two ultimate goals:
- Understand how the original melanoma from the skin spreads to the CNS. In order to study this we need to collect (and compare) the original skin melanoma, the CNS melanoma, as well as any other melanoma that has not metastasized to the CNS.
- Develop a diagnostic blood test that will early identify subjects at high risk for developing CNS metastasis or patients who may already have CNS metastasis but the MRI or the CAT scan cannot yet detect it. Thus, the investigators plan to collect CSF from subjects like you who have melanoma CNS metastases in order to confirm the presence of this biomarker.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing a craniotomy | – | –This group will include those subjects who have consented to have either a craniotomy or a laminectomy to resect an intramedullary tumor. |
| Metastases, no craniotomy | – | –These subjects have metastases but have either chosen not to undergo removal of the cancer or their neurosurgeon does not recommend surgical approach or they have been diagnosed with metastatic melanoma but do not have CNS metastases. |
| Healthy Volunteers | – | –Subjects who do not have known melanoma or metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (25 listed)
- Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are scheduled for craniotomy:
- Regarding patients with distant metastatic melanoma and established melanoma CNS metastases who are not having a craniotomy and before they undergo external beam irradiation or stereotactic radiosurgery (patient's and/or neurosurgeon's preference):
- Regarding patients who have distant metastatic melanoma without radiographically detectable melanoma CNS metastases but are willing to undergo lumbar puncture:
- Regarding healthy volunteers
Key exclusion criteria (9 listed)
- For study subjects, patients with extradural lesions, i.e. those that originate from the bone (calvarium or vertebrae), will not be considered.
- Any significant psychiatric disease, medical intervention, or other conditions, which in the opinion of the Investigators, could impair proper discussion of the informed consent or compromise participation to the clinical trial.
- Active systemic treatment for metastatic melanoma within 2 days from the collection of specimens (brain tumor tissue, peripheral blood, CSF). Corticosteroids, other immunosuppressive anti-inflammatory and anti-epileptic medications are allowed.
- Patients who have undergone whole brain irradiation therapy within the last 30 days. Therefore neither CNS lesions nor CSF are considered suitable for collection.
- Patients with growing CNS lesions at an area that has previously undergone radiosurgery within 3 months prior to enrollment in this study. Therefore CNS tumors from previously irradiated areas using radiosurgery are not considered suitable for collection although CSF is allowed for collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Stergios Moschos, MD principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma and CNS Metastases, run by University of Pittsburgh.
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 25 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Jul 2016. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 27 Jul 2016.