Brain tumor biomarker study

Not Applicable

• Conditions: Health Condition 1: C719- Malignant neoplasm of brain, unspecified

• Registration Number: CTRI/2021/01/030566
• Lead Sponsor: Johns Hopkins University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of genetic biomarkers from brain tumor and cerebrospinal fluid samplesTimepoint: By the end of the duration of the study

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable