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The purpose of this registry is to determine if select patients with CNS metastatic disease can be safely observed rather than treated. The investigators hypothesize that there is a subset of patients with small asymptomatic CNS mets that do not require treatment, these patients can simply be observed and will not have CNS progression.
Subjects will be given a consultation with physician investigators in the department of one of the study investigators, who will introduce the study if the subject is potentially eligible.
Information collected at initial assessment:
Observation and Follow-up Visits:
Treatment for Progression:
The study does not provide financial or other compensation to subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation | Experimental | Patients that meet all inclusion and exclusion criteria are monitored every 2 months for two years or until a therapeutic intervention is warranted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier survival analyses | Every two months for two years |
| CNS treatment-free survival rate | overall survival combined with CNS treatment | Every two months for two years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | determined by FACT-Br | Every two months for two years |
| Natural History of untreated CNS met | Measure the size of CNS target lesion over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Mazurek, MD | Cooper University Health System | Study Director |
| Gregory Kubicek, MD | Cooper University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Every two months for two years |
| Type of treatment | When/if needed | Every two months for two years |
| Indication for treatment | when/if treatment is needed due to discontinuation of observation. Classified between: increase in size to >1cm; interval growth of 0.4 cm in 6-8 weeks; development of edema or increase in edema; development of symptoms; or patient preference. | Every two months for two years |
| Neurocognitive testing | Montreal Cognitive Assessment | Every two months for two years |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |