| CTRI Number |
CTRI/2024/08/072229 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Expression and methylation status of TRIM (tripartite motif containing)-33 gene in Glioma |
|
Scientific Title of Study
|
Expression and Methylation Status of Tripartite motif containing 33 (TRIM33) gene in Glioma |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manju Subberwal |
| Designation |
Professor, Head of Department |
| Affiliation |
G B Pant Institute of Post Graduate Medical Education and Research |
| Address |
A-412
Department of Biochemistry
G B Pant Institute of Post Graduate Medical Education and Research (GIPMER)
Delhi
Central
DELHI
110002
India |
| Phone |
9718599054 |
| Fax |
|
| Email |
drmanjusubberwal17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chillarige Sudha Ankita |
| Designation |
Post Graduate Resident |
| Affiliation |
G B Pant Institute of Post Graduate Medical Education and Research |
| Address |
Academic block
Fourth floor
Department of Biochemistry
G B Pant Institute of Post Graduate Medical Education and Research
Delhi
Central
DELHI
110002
India |
| Phone |
9441763751 |
| Fax |
|
| Email |
sudhaankita09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manju Subberwal |
| Designation |
Professor, Head of Department |
| Affiliation |
G B Pant Institute of Post Graduate Medical Education and Research |
| Address |
A-412
Fourth floor
Department of Biochemistry
G B Pant Institute of Post Graduate Medical Education and Research
Delhi
DELHI
Central
DELHI
110002
India |
| Phone |
9718599054 |
| Fax |
|
| Email |
drmanjusubberwal17@gmail.com |
|
|
Source of Monetary or Material Support
|
| G B Pant Institute of Post Graduate Medical Education and Research(GIPMER)
Jawahar Lal Nehru Marg64 Khamba Raj Ghat New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Hospital |
| Address |
G B Pant Institute of Post Graduate Medical Education and Research (GIPMER)
Jawahar Lal Nehru Marg 64 Khamba Raj Ghat New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 MANJU SUBBERWAL |
G B Pant Institute of Post Graduate medical Education and Research (GIPMER) |
A-412
Fourth floor
Department of Biochemistry
G B Pant Institute of Post Graduate Medical Education and Research (GIPMER)
Jawahar Lal Nehru Marg
64 Khamba
Raj Ghat
New Delhi 110002
Central
DELHI |
9718599054
drmanjusubberwal17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL(Lok Nayak, G B Pant Institute of Post Graduate Medical Education and Research(GIPMER),Guru nanak Eye centre,New Delhi-110002) INSTITUTIONAL ETHICS COMMITTEE |
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 |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Study population will be divided into 3 groups:
Group A:
Patients with histopathologically proven Low-Grade Glioma or Non- Glial tumor.
Group B:
Patients with histopathologically proven High-Grade Glioma
Group C (Control Population):
Age and Gender matched healthy volunteers from Patient’s attendants, hospital
staff will be selected as control population. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females.
Patients with any systemic illnesses like any malignancy other than leptomeningeal tumor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Expression of TRIM33 gene in high grade glioma Vs non-glial tumors & low-grade
glioma.
2) Methylation status of TRIM33 gene in high grade glioma Vs non-glial tumors & low-grade
glioma. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Comparison of expression and methylation status of TRIM33 gene between high grade
glioma Vs non-glial tumors & low-grade glioma.
2) Association of expression and methylation status of TRIM33 gene between high grade
glioma VS non-glial tumors & low-grade glioma. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
22/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A cross-sectional study on the expression and methylation status of the TRIM-33 gene in glioma will be conducted at GIPMER, Delhi. The study population is divided into three groups. The first group includes 10 non-glial tumors and 10 low-grade gliomas, while the second group consists of 20 high-grade gliomas, and a third control group consisting of 40 age and gender matched healthy volunteers will be included. The tumor tissue chunk will be collected from the neurosurgery O.T. in PBS and RNA later, and preserved at -80 degrees Celsius. Additionally, 3 ml of whole blood will be collected to isolate DNA and RNA. Complementary DNA (cDNA) will be synthesized from the isolated RNA for expression studies, which will be conducted using RT-PCR. Methylation status will be assessed using MSPCR. The results will be analyzed using SPSS software version 25. Primers for the PCR will be designed as required for the study. |