World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 25 March 2020
Main ID:  CTRI/2019/02/017663
Date of registration: 14-02-2019
Prospective Registration: Yes
Primary sponsor: Datar Cancer Genetics Limited
Public title: CNS Tumors Liquid Biopsy
Scientific title: Utility of GliotrackTM, the liquid biopsy platform for gliomas in distinguishing glioblastoma from other CNS lesions with equivocal findings on neuroimaging. - GLIOLENs
Date of first enrolment: 19-02-2019
Target sample size: 100
Recruitment status: Not Yet Recruiting
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31387
Study type:  Observational
Study design:  Other Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable  
Phase:  N/A
Countries of recruitment
India
Contacts
Name: Dr Dadasaheb Akolkar   
Address:  First Floor, Department of Research and Innovations, Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422010 422010 Ajmer, MAHARASHTRA India
Telephone: 7387705888
Email: dadasaheb.akolkar@datarpgx.com
Affiliation:  Datar Cancer Genetics Limited
Name: Dr Dadasaheb Akolkar   
Address:  First Floor, Department of Research and Innovations, Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad, Nasik, Maharashtra 422010 422010 Udupi, MAHARASHTRA India
Telephone: 7387705888
Email: dadasaheb.akolkar@datarpgx.com
Affiliation:  Datar Cancer Genetics Limited
Key inclusion & exclusion criteria
Inclusion criteria: i. Suspected glioblastoma or its differential diagnosis disorder patients who are therapy naïve (not yet undergone surgery/chemotherapy/radiotherapy); the conditions include glioblastoma, cerebral metastasis, primary CNS lymphoma, cerebral abscess, anaplastic astrocytoma, tumefactive demyelination, subacute cerebral infarction, cerebral toxoplasmosis.

ii.Age â?¥ 18 years.

iii.Female patient is not pregnant.

iv.Provision of signed and dated informed consent form.

v.Stated willingness to comply with all study procedures.


Exclusion criteria: i.Patients who fail to meet all of the above criteria for cases will be excluded. Failing to meet any single criteria would be sufficient grounds for exclusion.

ii.Age <18 years.

iii.Active or latent hepatitis B or active hepatitis C or any uncontrolled infection at screening, including (but not limited to) HIV, HPV or tuberculosis.

iv.Patient has an investigational medicinal product within the last 30 days of blood collection.

v.Pregnant women.

vi.Personal history of cancer in the past.

vii.Blood transfusion in past 1 month.

viii.(PET-)CT scan in past 14 days.

ix.Patients must have discontinued steroids â?¥ 1 week prior to screening,

NOTE: The following steroids are permitted (low dose steroid use is defined as prednisone 10 mg daily or less, or bioequivalent dose of other corticosteroid):

a.Temporary steroid use for CT imaging in setting of contrast allergy,

b.Low dose steroid use for appetite,

c.Chronic inhaled steroid use,

d.Steroid injections for joint disease,

e.Stable dose of replacement steroid for adrenal insufficiency or low doses for non-malignant disease,

f.Topical steroids.



Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Other disorders of the nervous system
Intervention(s)
Primary Outcome(s)
To evaluate the utility of GliotrackTM in distinguishing CNS malignancies from non-malignant disorders with equivocal findings on neuroimaging.

Outcome Measure: Positive predictive value of GliotrackTM to differentiate CNS malignancies from non-malignant disorders with equivocal findings on neuroimaging.

Timepoint: Evaluation Timepoint: Day 0 (Blood ± CSF sampling)

Secondary Outcome(s)
To determine the grade of the CNS malignancy.

Outcome Measure: Comparison of molecular profiling of tissue and corresponding blood sample of the study participants.

Timepoint: Evaluation Timepoint: Day 0 (Blood ± CSF sampling).
To distinguish primary CNS malignancy from CNS metastasis of other solid organ tumors.

Outcome Measure: Comparison of histopathological typing from tissue and profiling from blood sample of study participants.

Timepoint: Evaluation Timepoint: Day 0 (Blood ± CSF sampling)
Secondary ID(s)
NIL
Source(s) of Monetary Support
1) Datar Cancer Genetics Limited, F-8, D Road, MIDC, Ambad,Nasik, Maharashtra 422 010
2) Canconnect Foundation, Flat No.12, Ameya Sankul, B Wing, Sharanpur Road, Nasik, Maharashtra 422 005
Secondary Sponsor(s)
Canconnect Foundation
Ethics review
Status: Approved
Approval date: 01/01/2019
Contact:
Datar Cancer Genetics Limited Ethics Committee
Status: Approved
Approval date: 22/01/2019
Contact:
Institutional Ethics Committee Clinical Studies Apollo Hospitals Hyderabad
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history