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Brain tumor biomarker study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/01/030566
Enrollment
100
Registered
2021-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Johns Hopkins University School of Medicine
Lead Sponsor

Eligibility

Inclusion 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 6) Both men and women of all races and ethnic groups are eligible for this study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Identification of genetic biomarkers from brain tumor and cerebrospinal fluid samplesTimepoint: By the end of the duration of the study

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Pallavi Ghana

Strand Life Sciences Pvt Ltd

aditi.c@strandls.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026