| CTRI Number |
CTRI/2025/01/079820 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Biomarkers in Brain tumors |
|
Scientific Title of Study
|
Systemic Biomarkers to predict Radiation-Induced Neurocognitive decline in pediatric and young adults with primary brain tumors |
| Trial Acronym |
BIO-RIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavita Pal |
| Designation |
Scientific officer E |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer(ACTREC),Tata Memorial centre |
| Address |
Clinical Pharmacology Laboratory, Advanced Centre for Treatment, Research and Education in Cancer(ACTREC)-Tata Memorial Centre,Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9653493628 |
| Fax |
|
| Email |
drpalkavita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Pal |
| Designation |
Scientific officer E |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer(ACTREC),Tata Memorial centre |
| Address |
Clinical Pharmacology Laboratory, Advanced Centre for Treatment, Research and Education in Cancer(ACTREC)-Tata Memorial Centre,Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9653493628 |
| Fax |
|
| Email |
drpalkavita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Pal |
| Designation |
Scientific officer E |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer(ACTREC),Tata Memorial centre |
| Address |
Clinical Pharmacology Laboratory, Advanced Centre for Treatment, Research and Education in Cancer(ACTREC)-Tata Memorial Centre,Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9653493628 |
| Fax |
|
| Email |
drpalkavita@gmail.com |
|
|
Source of Monetary or Material Support
|
| TRAC, Tata Memorial Hospital, Dr E Borges road, Parel,Mumbai, Maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
Intramural funding Tata Memorial Center |
| Address |
TRAC, 3rd floor main building, Tata Memorial Hospital,Dr.E Borges road, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavita Pal |
Advanced Centre for Treatment, Research and Education in Cancer |
KS 102, Clinical Pharmacology lab, Advanced Centre for Treatment, Reseach and Education in Cancer, TMC, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9653493628
drpalkavita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
This is an observational study |
| Intervention |
NIL |
THIS IS AN OBSERVATIONAL TRIAL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 5-39 years
2. Histological diagnosis of primary brain tumor
3. Decision for treatment with radical intent radiotherapy
4. Signed assent and parental consent form for pediatric age group and signed consent form for adults. |
|
| ExclusionCriteria |
| Details |
1. Inability to undergo neurocognitive evaluation
2. Palliative radiotherapy.
3. Expected life expectancy less than 1 year |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Biomarkers associated with radiation-induced neurocognitive decline |
The time point for sample collection (peripheral blood) would be before starting radiotherapy (Whenever available pre-operative blood samples will be collected). Along with this baseline sample, blood sample will also be collected weekly during the course of fractionated radiation (weekly for 6-7 weeks) and thereafter, 1 month after radiation completion and periodically at regular intervals (every 6-12 months) during follow-up visits. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prediction of neurocognitive decline through identification of systemic biomarkers. |
The time point for sample collection (peripheral blood) would be before starting radiotherapy (Whenever available pre-operative blood samples will be collected). Along with this baseline sample, blood sample will also be collected weekly during the course of fractionated radiation (weekly for 6-7 weeks) and thereafter, 1 month after radiation completion and periodically at regular intervals (every 6-12 months) during follow-up visits. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiation constitutes an integral component in the management of primary brain tumors in pediatric and young adults like medulloblastoma, ependymoma, low-grade glioma, pituitary tumors, etc. A decline in neurocognitive outcomes is a multifactorial effect occurring from the primary disease as well as associated with treatments, including radiation. Since many of these tumors are highly curable, it is crucial to reduce long-term side effects, including memory loss, to improve the quality of life in these patients, leading to better rehabilitation. Radiation-induced neurocognitive deterioration is postulated to occur from multiple factors like neuroinflammation, vascular damage, and depletion of neural stem cells. The proposed study will prospectively evaluate 200 pediatric and young adults with brain tumors treated with radiotherapy. Biological samples (peripheral blood and cerebrospinal fluid) will be procured during routine investigations (an additional amount will be collected for study purposes without the need for additional investigations). Serial blood markers (whenever available pre-operative and before, during, and after completion of radiation) of neuroinflammation and neural markers will be tested in patients undergoing radiation as part of their standard treatment, and correlate with the neurocognitive outcomes measured by age-appropriate Wechsler intelligence scales. Also, the impact of clinical (e.g. age) and radiotherapy parameters like volume, dose of radiation, and technique (photon versus proton therapy) on acute (during radiotherapy) and late systemic inflammatory markers will be analyzed. The study will even provide the opportunity to know the influence of radiation on systemic neuroinflammatory markers in the human population, providing better biological insights into the neurocognitive decline. If proven successful, these biomarkers can be used in routine clinical practice for early intervention to improve neurocognitive function in patients receiving radiation (even for other histology or other patients receiving radiation like brain metastasis). |