Health Condition 1: G89-G99- Other disorders of the nervous system
Conditions
Interventions
None listed
Sponsors
Datar Cancer Genetics Limited
Canconnect Foundation
Eligibility
Inclusion 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 >= 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
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 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 >= 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
India
Contacts
Public ContactDr Dadasaheb Akolkar
Datar Cancer Genetics Limited
Outcome results
None listed