Tracing Brain Tumors Through Deep Time (TRACE)

Brain tumors involve different age groups with a wide range of tumor types involving different anatomical compartments of the brain. The evolution of the brain in vertebrates, including the most recent homo species (including humans), has occurred through increasing structural complexity in more evolved species. In the retrospective study, we will investigate the location of the tumors and different structural aspects of skull anatomy in patients with brain tumors. The information will be compared with the anatomical evolution of the brain and skull in vertebrates to look for possible associations, which can provide insights into evolutionary biology.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor; Oncology
• Intervention / Treatment: Diagnostic test: Imaging with CT and MRI

Detailed Description

Patients (pediatric and adults) with a diagnosis (radiological/ histopathological) of primary brain tumors registered in the neuro-oncology disease management group between January 2005 and December 2023 will be screened. Approximately 500-600 patients are expected to be eligible per year with imaging data (approximately 500 patients are treated annually with radiation in our center with available CT data for radiation planning, and another 100-200 patients having pre-operative or post-operative scans). For the above-mentioned time period, data is expected to be available from approximately 10,000 patients, which will be the upper limit of sample size for the current study.

The area of the primary tumor (or cavity and residual tumor indicating original location for post-operative data) will be segmented on CT and /or MRI as available. The peritumoral edema will be excluded from the segmented region. The segmentation will be done manually in an initial cohort of approximately 200-500 patients. Subsequently, a machine learning algorithm like a 3D U-net or deep learning-based technique will be trained on the initial data (and validated on the next 100-200 patients to assess algorithm accuracy and robustness) for rapid implementation and segmentation of the large data set. Once brain tumor regions are identified across the entire population, density maps will be generated to reciprocate the location of tumors on a quantitative scale as per age of the patient during diagnosis (age in years as continuous data and categorical data, i.e., age groups, e.g., infants, children, teens, adolescents. adults, and elderly). The generated density maps will be compared with regions of vertebrate brain regions (with openly available literature) across species with regards to the geological scale/ deep time units, e.g., in units of 10-50 million years. Similarly, the skull bony anatomy will be extracted from CT and/ or MRI data (applying techniques like window intensity thresholds without the need for segmentation). Patients with major defects in the calvarial skull from increased intracranial pressure or surgical interventions will be excluded from the analysis of calvarial anthropometry (however, it will be available for skull base anatomy assessment). The organizational patterns will be analyzed using machine learning models and other statistical models like Bayesian statistics and compared with other publicly available normal human populations without brain tumors (adjusting for age, race as applicable), fossil data of vertebrates/ hominids, non-human primates for link recognition. The density maps and anthropometric data will be compared within the entire cohort of patients with brain tumors (from the study) stratified by factors like age (as mentioned earlier), tumor location (e.g., supratentorial vs. infratentorial), tumor grade (benign vs. low grade vs high grade). The statistical analysis for density maps and anthropometry will be done by sharing anonymized data with collaborators with expertise in similar research from the Indian Statistical Institute (Geological Studies Unit and Interdisciplinary Statistical Research Unit).

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: ARCHYA DASGUPTA, MD; Phone Number: 6861 91-22-24177000; Email: archya1010@gmail.com

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Recruiting
      • Tata Memorial Hospital
      • Contact: Dr Archya Dasgupta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of primary brain tumors will be screened for the study. Approximately 500-600 patients are treated annually with radiation in our center with available CT data for radiation planning, and another 100-200 patients having pre-operative or post-operative scans. For the above-mentioned time period, data is expected to be available from approximately 10,000 patients, which will be the upper limit of sample size for the current study.

Description

Inclusion Criteria:

• All patients diagnosed with primary brain tumors with available pre/ post-operative or pre-radiation brain images with computed tomography (CT) or magnetic resonance imaging (MRI)

Exclusion Criteria:

• CT/ MRI is not available before cranial radiotherapy
• Artifacts causing distortion of skull (bony) anatomy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age-based density maps of brain tumor location	Tumor location for different age groups will be analyzed using proportions (percentage of tumor area in normal brain).	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric analysis of skulls	Cranial index (maximum cranial width/ maximum cranial length x100) will be analyzed using descriptive statistics (mean, median, range, standard deviation).	36 months

Collaborators and Investigators

• Sponsor: Tata Memorial Centre
• Collaborators: Indian Statistical Institute, Kolkata
• Investigators: Principal Investigator: Archya Dasgupta, MD, Tata Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 10, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Brain tumor; Evolution; CNS tumor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 4410

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No