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Liquid biopsy in brain tumours

Paired exosomal mRNA, tumoral somatic DNA sequencing and DNA methylation profiling in patients with brain tumours on radiology, to develop a liquid biopsy test.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/09/036861
Enrollment
3000
Registered
2021-09-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

Exsegen Genomics Research Pvt Ltd
Lead Sponsor
Exsegen Genomics Research Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary objective: 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. Timepoint: At 3 months, 6 months and 1 year from commencement of study

Secondary

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

Countries

India

Contacts

Public ContactDr Amitava Ray MBBS MD FRCSEd FRCS Neurosurgery

Founder Director and Clinical Lead

amit@exsegen.com9000420030

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026