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Clinical Trials/CTRI/2021/01/030566
CTRI/2021/01/030566
Not yet recruiting
未知

Measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients. - Not applicable

Johns Hopkins University School of Medicine0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Sponsor
Johns Hopkins University School of Medicine
Status
Not yet recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Age \>18 years for Cohort 1: patients with suspected or confirmed malignant brain tumor who are eligible for surgical resection, chemotherapy or radiation treatments, as identified by the site PI or Co\-Is through routine clinical care processes
  • 2\. Age \>12 years for Cohort 2: patients, including children, with malignant brain tumor, who are undergoing a diagnostic or therapeutic lumbar puncture, as identified by the site PI or Co\-Is through routine clinical care processes
  • 3\. Life expectancy of greater than 6 months
  • 4\. Patients must have normal lab criteria as defined below:
  • 4a) Platelets \>\= 100,000/mcL
  • 4b) PTT above institutional limits
  • 4c) INR above institutional limits
  • 5\) Ability to understand and the willingness to sign a written Informed Consent Form for patients \>18 years and an Assent form for patients \<18 years
  • 6\) Both men and women of all races and ethnic groups are eligible for this study

Exclusion Criteria

  • 1\) Patients who have an uncontrolled infection
  • 2\) Patients who are receiving an investigational agent(s) that increases the risks associated with cerebrospinal fluid sampling
  • 3\) Patients with clinical or radiographic evidence of elevated intracranial pressure (such as papilledema, obstructive hydrocephalus, or signs of herniation)
  • 4\) Patients who are coagulopathic and are taking blood thinning products, such as plavix, lovenox, or coumadin. Patients maybe on steroids or anti\-convulsant therapy without affecting eligibility
  • 5\) Women who are pregnant or suspect they are pregnant or lactating mothers

Outcomes

Primary Outcomes

Not specified

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