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CTRI Number  CTRI/2024/01/061244 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Mutational analysis in Gastrointestinal Stromal tumour (GIST) 
Scientific Title of Study   Prognostic impact of mutational analysis and it’s therapeutic implications in Gastrointestinal Stromal Tumours (GIST) 
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 Antara Sanyal 
Designation  Senior Resident 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8449665678  
Fax    
Email  drsanyal27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Soumya Surath Panda 
Designation  Professor HOD 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8895370579  
Fax    
Email  soumyasurathpanda@soa.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Soumya Surath Panda 
Designation  Professor HOD 
Affiliation  Institute of Medical sciences and SUM Hospital 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8895370579  
Fax    
Email  soumyasurathpanda@soa.ac.in  
 
Source of Monetary or Material Support  
Institute of Medical Sciences and SUM Hospital Siksha O Anusandhan 
 
Primary Sponsor  
Name  Dr Antara Sanyal 
Address  Department of Medical Oncology Institute of Medical sciences and SUM Hospital Siksha O Anusandhan Kalinga Nagar Ghatikia Bhubaneswar 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ANTARA SANYAL  Institute of Medical sciences and SUM Hospital  Department of Medical Oncology Institute of Medical Sciences and SUM Hospital KALINGA NAGAR BHUBANESWAR
Khordha
ORISSA 		 8449665678

drsanyal27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL, Siksha O Anusandham (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, (2) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, (4) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (5) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Newly diagnosed case of GIST
2 Treatment naïve

Diagnosis will be based upon the morphology and immunophenotype of the primary followed by mutational analysis
 
 
ExclusionCriteria 
Details  1 Consent refusal
2 Patients with inadequate sample in tissue biopsy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the mutation pattern at baseline and follow-up patients with newly diagnosed GISTs
 		 3 months 6 months 9 months 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
To audit retrospective data for mutational analysis profile clinicopathological findings & OS over a period of 5 years (2017-2022).
PFS & OS will be prospectively observed in patient cohort
 		 Baseline, 3 months, 6 months, 9 months, 12 months 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   12/01/2024 
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)   Open to Recruitment 
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  
1 M/c mesenchymal malignancy; 1-2% GI malignancies
2 Arises from the pluripotent mesenchymal cells
3 M/c site: Stomach & small intestine
4 ~47% present in advanced stage. Liver or peritoneal metastatic involvement
5 CT is gold standard for abdominal primaries with use of oral + i/v contrast improves evaluation of tumour margin
6 best categorized by molecular subtype, which have differing clinical characteristics and treatment response KIT (~69%–83%) PDGFRA (~5%–10%),10%– 15% of GISTs without KIT/PDGFRA mutations.  SDC deficiency or BRAF or loss-of-function of NF1, that lead to activation of the PI3K/ mTOR and/or the RAS/RAF/MAPK pathways
7 In the era of precision oncology, tailored treatment protocols based on medical genetics form the basis of evidence-based management.

 
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