NCT06036381

Brief Summary

Glioma are type of primary brain tumors arising within the substance of brain. Different type of gliomas are seen which are classified depending upon pathological examination and advanced molecular techniques, which help to determine the aggressiveness of the tumor and outcomes. Artificial intelligence uses advanced analytical process aided by computer which can be undertaken on the medical images. We plan to use artificial intelligence techniques to identify the abnormal areas within the brain representing tumor from the radiological images. Also, similar approach will be undertaken to classify gliomas with good or bad prognosis, to differentiate glioma from other type of brain tumors, and to detect response after treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2024Dec 2026

First Submitted

Initial submission to the registry

August 28, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

August 28, 2023

Last Update Submit

April 8, 2025

Conditions

Keywords

GliomaRadiomicsArtificial IntelligenceMachine learning

Outcome Measures

Primary Outcomes (2)

  • Autosegmentation of tumor

    The correlation of tumor region between manual segmentation and artificial intelligence-based autosegmentation model will be assessed using the Dice coefficient of similarity.

    3 years

  • Prognostication of gliomas

    Radiomic signature in prognostication of gliomas with estimation of progression-free survival and overall survival using Kaplan Meier plots and radiomics score-based nomograms.

    3 years

Secondary Outcomes (2)

  • Response assessment in gliomas

    3 years

  • Differentiation of glioma from non-glioma histology

    3 years

Interventions

Radiomic analysis of imaging will be undertaken as a standard of care to develop computational algorithms for patients treated in our institution.

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will be according to the Inclusion and Exclusion Criteria . Study Includes vulnerable participants also. Minors (up to 18 years),Elderly

You may qualify if:

  • Patients with glioma or glioma-mimicking pathology with imaging available in TMC between January 2010 and December 2022.

You may not qualify if:

  • Imaging done outside TMC.
  • Motion artifacts or other artifacts causing image degradation.
  • Size of tumor or region of interest \< 1 cm in the largest dimension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Dr. ARCHYA DASGUPTA, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. ARCHYA DASGUPTA, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Radiation Oncology

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 13, 2023

Study Start

February 15, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations