No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for patients with brain tumors who are having a biopsy. Participants will have a small device placed during the biopsy to help collect fluid samples in the future.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with a brain tumor.
I am scheduled for a biopsy at Mayo Clinic.
I am willing to give my consent for the trial.
I agree to have my fluid samples taken at least two times.
I will allow my fluid samples to be stored for research.
You may not be able to join if
I am pregnant or under 18 years old.
I am currently too sick to have a biopsy.
I have had a wound infection in the past.
My doctor thinks I am not a good candidate for this procedure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without…
This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
* Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota \[MN\])
* Willingness of the patient to provide informed consent
…
Inclusion Criteria:
* Clinical and radiographic evidence suggesting a diagnosis of a brain tumor
* Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota \[MN\])
* Willingness of the patient to provide informed consent
* Patient is willing to have their Ommaya sampled on at least 2 future occasions
* Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
Exclusion Criteria:
* Vulnerable populations including pregnant women, prisoners, and individuals \< 18 years old
* Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness
* Prior history of any wound infection
* Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns
Contacts
No contact information available.
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