An observational study in Melanoma and Brain Metastases, sponsored by University of Pittsburgh. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.
Sponsored by University of Pittsburgh · Observational
The purpose of this study is to collect and bank samples of blood and tissues (such as brain tissue or lymph nodes), as well as cerebrospinal fluid (CSF), which is the fluid that bathes and cushions the spinal cord. The investigator will analyze DNA biomarkers in the samples. The investigator hopes that by studying the biomarkers, he can develop tests in the future that can detect central nervous system (CNS) metastasis in blood samples before they show up on x-ray and develop medicines that can specifically target CNS metastasis.
Among the different sites to which melanoma can spread, the Central Nervous System (CNS) has the highest chance of developing metastases. Prognosis for metastatic melanoma involving the CNS is worse than that of CNS metastases from other cancers. Therefore, it is felt that early identification of this condition, even before it is found on x-ray (either MRI or CT scan), would be beneficial so that patients can undergo treatment earlier.
The investigator hypothesizes that the tumor cell genetics, expressed proteins, and/or signaling pathways of melanoma brain metastases may exhibit features that distinguish melanoma brain metastases. The investigator further hypothesizes that melanoma brain metastases may be associated with changes in the cerebrospinal fluid, where protein fragments expressed by melanoma brain metastases may be shed that cannot be found in normal CNS tissues, extracranial metastases (MEM) or at the same levels in the peripheral blood.
3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.
This study's enrollment of 7 is below the median of 182 across 448 observational studies indexed under Melanoma.
Browse Melanoma studies →University of Pittsburgh is the lead sponsor of 1,414 studies on the registry; 168 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with biopsy-proven melanoma who present with melanoma CNS metastases, a condition that has been previously either biopsy-proven or there is strong suspicion based on the radiologic imaging (brain MRI or brain CT with intravenous contrast) will be considered for the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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):
Exclusion Criteria:
Patients who have scheduled craniotomy with melanoma brain metastases will have the following specimens collected: 1. CNS tumor specimens, specifically the remaining portion from the resected melanoma CNS metastasis 2. the remaining portion from the adjacent "normal" CNS tissue. No additional normal brain tissue will be collected for research purposes only, however the routinely collect peritumoral tissue will be retained. 3. melanoma specimens from other extracranial, clinically palpable metastatic sites. 4. CSF taken at around the time of the craniotomy procedure 5. peripheral blood prior to craniotomy.
Procedure: Craniotomy scheduled
For those eligible patients who are not having a craniotomy: 1. collection of CSF will be performed by lumbar puncture or from the patient's Ommaya reservoir, if present. 2. collection of peripheral blood. NOTE: Only patients who have no absolute contraindications or up to two relative contraindications will be considered for lumbar puncture
Procedure: Collection for non-craniotomy
Resection of affected brain tissue
CSF, Blood, biopsy
Collection of blood, tumor tissue samples and adjacent uninvolved tissue and Cerebrospinal Fluid
Collection of these samples to help determine: if CNS melanoma metastases are similar to primary cutaneous melanomas, and assist in efforts to develop biomarkers that predict development of CNS melanoma metastases from the cutaneous primary lesion; or if CNS melanoma metastases are similar to extracranial metastases, and assist in efforts to develop effective systemic therapies for extracranial MM that also take into account the molecular profile of CNS melanoma metastases would more likely have an impact upon development of CNS melanoma metastases.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2014 to primary completion in Aug 2019, 60 months.
Of 154 non-industry observational studies under Melanoma, half reached primary completion within 189 months of starting (the median), counting those still running; a quarter within 44. This study's 60 months is below that.
Counting every sponsor, half of 206 studies reached it within 82 months; a quarter within 37 and three quarters within 223.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.