iquid biopsy in brain tumours

Not Applicable

Conditions: Health Condition 1: C69-C72- Malignant neoplasms of eye, brain and other parts of central nervous system

Registration Number: CTRI/2021/09/036861

Lead Sponsor: Exsegen Genomics Research Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

(1) Subjects with suspected brain tumour on neuroimaging have not undergone any treatment for the suspected disease at the time of blood sample collection for this disease

(2) Age- any age with proper consent/assent

(3) Female patient - not pregnant

(4) Provision of signed and dated informed consent form

(5) Stated willingness to comply with all study procedures

Exclusion Criteria

(1)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.

(2)Prolonged cortico-steroid therapy, ideally steroid naïve

(3) Active or latent hepatitis B or active hepatitis C or any uncontrolled infection

(4) Human Immunodeficiency Virus (HIV) positive

(5) Active infections, COViD19, HIV, HPV, HBV, HCV, Tuberculosis etc.

(6) Patient has an investigational medicinal product within the last 30 days of blood collection.

(7) PET -CT scan in past 14 days

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective: <br/ ><br>The primary objective of this study is to diagnose brain lesions with a specificity and sensitivity approaching a traditional biopsy in any patient having a radiological lesion that may represent a brain tumour. <br/ ><br>Timepoint: At 3 months, 6 months and 1 year from commencement of study

Secondary Outcome Measures

Name	Time	Method
Secondary objective: <br/ ><br>1.To accurately predict already defined molecular subtypes of lesions based on serum exosomal profiles. <br/ ><br>2. To assess the feasibility of being able to use this information to tailor therapy that can be studied in future. <br/ ><br>Timepoint: At one year after the start of the study