RECRUITING

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

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Conditions

Brain Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

Official Title

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

Quick Facts

Study Start:2021-01-15
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04692337

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years.
  2. * Clinical and radiographic evidence suggesting a diagnosis of a brain tumor.
  3. * Planned neurosurgical procedure resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
  4. * Willing to undergo neurosurgical resection at Mayo Clinic (Rochester, MN).
  5. * Ability to understand and the willingness to sign a written informed consent document.
  6. * Patient is willing to have their Ommaya sampled on at least 2 future occasions.
  7. * Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)
  1. * Vulnerable populations including pregnant women, prisoners and individuals \<18 years old.
  2. * Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
  3. * Prior history of any wound infection
  4. * Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons could (but need not necessarily) include factors related to surgical anatomy, clinical evidence of significant immunosuppression, and/or elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns.

Contacts and Locations

Study Contact

Bambi Wessel
CONTACT
(507) 293-1963
Wessel.Bambi@mayo.edu
Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Terry C. Burns, MD, PhD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Terry C. Burns, MD, PhD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-15
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-01-15
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Brain Tumor