iquid biopsy of brain tumors using cerebrospinal fluid analysis

Not Applicable

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

• Registration Number: CTRI/2022/06/042986
• Lead Sponsor: Strand Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age more than or equal to 18 years for Cohort 1

2. Age more than or equal to 12 years for Cohort 2

3. Life expectancy of greater than 6 months

4. Patients must have normal laboratory criteria as defined below:

- Platelets >100,000/mcL

- PTT as per institutional limits

- INR as per institutional limits

5. Ability to understand and the willingness to sign a written Informed Consent Form for patients more than

or equal to 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. Metastatic brain tumors where the brain is not the primary site.

3. Patients who are receiving an investigational agent(s) that increases the risks associated with

cerebrospinal fluid sampling.

4. Patients with clinical or radiographic evidence of elevated intracranial pressure (such as papilledema,

obstructive hydrocephalus, or signs of herniation).

5. Patients who are coagulopathic and are taking blood thinning products such as plavix, lovenox, or

coumadin. Patients may be on steroids or anti-convulsant therapy without affecting eligibility.

6. Women who are pregnant or suspect they are pregnant and lactating mothers.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test the feasibility of measuring tumor-specific mutations of malignant brain tumors using CSF derived <br/ ><br>circulating tumor DNA.Timepoint: Pre-surgery for Cohort 1 <br/ ><br>On follow-up for Cohort 2

Secondary Outcome Measures

Name	Time	Method
ot ApplicableTimepoint: Not Applicable