Cooper University Hospital
Camden, New Jersey, 08103, United States
NCT Number: NCT02866981
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.
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Interventional
Phase 2
Camden, New Jersey, 08103, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Every two months for two years
Kaplan-Meier survival analyses
Time frame: Every two months for two years
overall survival combined with CNS treatment
Time frame: Every two months for two years
determined by FACT-Br
Time frame: Every two months for two years
Measure the size of CNS target lesion over time
Time frame: Every two months for two years
When/if needed
Time frame: Every two months for two years
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.
Time frame: Every two months for two years
Montreal Cognitive Assessment
The Cooper Health System
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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