| CTRI Number |
CTRI/2021/01/030566 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Biomarker R&D study |
| Study Design |
Other |
|
Public Title of Study
|
Brain tumor biomarker study |
|
Scientific Title of Study
|
Measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Chatterjee |
| Designation |
Associate Director, R&D |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Strand Life Sciences Pvt Ltd,
Research Informatics, Research & Development
University of Agricultural Sciences,
Convention Centre,
Veterinary College Campus,
Bellary Road
Bangalore
KARNATAKA
560024
India |
| Phone |
|
| Fax |
|
| Email |
aditi.c@strandls.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Chatterjee |
| Designation |
Associate Director, R&D |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Strand Life Sciences Pvt Ltd,
Research Informatics, Research & Development
University of Agricultural Sciences,
Convention Centre,
Veterinary College Campus,
Bellary Road
Bangalore
KARNATAKA
560024
India |
| Phone |
|
| Fax |
|
| Email |
aditi.c@strandls.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Ghana |
| Designation |
Associate Director, Project Management |
| Affiliation |
Strand Life Sciences Pvt Ltd |
| Address |
Strand Life Sciences Pvt Ltd,
Research Informatics,
Project Management
University of Agricultural Sciences,
Convention Centre,
Veterinary College Campus,
Bellary Road
Bangalore
KARNATAKA
560024
India |
| Phone |
|
| Fax |
|
| Email |
pallavi.ghana@strandls.com |
|
|
Source of Monetary or Material Support
|
| Johns Hopkins University, School of Medicine
Baltimore, MD, USA
|
|
|
Primary Sponsor
|
| Name |
Johns Hopkins University School of Medicine |
| Address |
600 North Wolfe Street
Phipps 118
Baltimore, MD 21287, USA
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mayur Kaku |
HealthCare Global Enterprises Limited, Bangalore |
No.8 HCG Towers
(Department of Neurosurgery)
P. Kalinga Rao Road
Sampangiram Nagar
Bangalore 560027
Bangalore
KARNATAKA |
8951783386
mayurvkaku@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HCG-Central Ethics Committee, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of genetic biomarkers from brain tumor and cerebrospinal fluid samples |
By the end of the duration of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/01/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Protocol No: SLS-JHM-01
Title: Measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients
Study Sponsor: Johns Hopkins University, School of Medicine
Study Type: Observational, non-interventional, multicentric
Study sites: Upto 8 sites
Total number of subjects: 100
Study Arms: 2 1st Arm: Brain Tumor Malignancy with chemo/radiotherapy 2nd Arm: Brain Tumor Malignancy with lumbar puncture
Rationale: Tumor DNA load in body fluids (circulating tumor DNA or ctDNA) can be a minimally invasive adjunct biomarker for determining tumor burden and also for determining tumor mutations targetable by therapy.
Objectives: Primary objective: To test the feasibility of measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients Secondary objective: To determine progression-free survival (PFS) and overall survival (OS) in patients with tumor-specific genetic alterations detected in the cerebrospinal fluid
Study Design: This is a multi institutional study to evaluate the feasibility of measuring tumor-specific genetic alterations in cerebrospinal fluid (CSF) as a biomarker of tumor burden in malignant brain tumor patients. Patients with suspected or confirmed malignant brain tumor who are eligible for surgical tumor resection, treatment with chemo or radiation therapy, patients with malignant brain tumors who are undergoing the therapeutic or diagnostic lumbar puncture, will be enrolled into this study. The primary goal of this study is to determine the feasibility of detecting and quantifying ctDNA in CSF of patients with malignant brain tumors. Tumor tissue and CSF will be collected.
|