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CTRI Number  CTRI/2021/07/034510 [Registered on: 01/07/2021] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Interaction of Vitamin D Receptor forms with outcomes and survival in allogeneic stem cell transplant patients. 
Scientific Title of Study   Interaction of Vitamin D Receptor gene polymorphism with HLA alleles and its correlation with immune modulation affecting graft outcomes and survival in HLA matched sibling allogeneic stem cell transplantation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
900538  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navin Khattry 
Designation  Professor 
Affiliation  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer 
Address  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer,Room No 211, Paymaster Shodhika, Sector 22, CISF Rd, Owe Camp, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  02268735096  
Fax    
Email  nkhattry@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Navin Khattry 
Designation  Professor 
Affiliation  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer 
Address  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer,Room No 211, Paymaster Shodhika, Sector 22, CISF Rd, Owe Camp, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  02268735096  
Fax    
Email  nkhattry@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Navin Khattry 
Designation  Professor 
Affiliation  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer 
Address  Tata Memorial Centre Advance Centre for Treatment, Research and Education in Cancer,Room No 211, Paymaster Shodhika, Sector 22, CISF Rd, Owe Camp, Kharghar, Navi Mumbai

Raigarh
MAHARASHTRA
410210
India 
Phone  02268735096  
Fax    
Email  nkhattry@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Center, ACTREC 
 
Primary Sponsor  
Name  Tata Memorial Centre  
Address  Dr. E Borges Road, Parel, Mumbai  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Navin Khattry  Tata Memorial Centre, Advance Centre for Treatment, Research and Education in Cancer  Department of Medical Oncology, Room no 211, Paymaster Shodhika,TMC ACTREC, Sector 22, CISF Road, Owe Camp, Navi Mumbai, Kharghar, 410210
Raigarh
MAHARASHTRA 
02268735096

nkhattry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMC-IEC-III   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients who underwent HSCT with allogeneic matched sibling donor from December,
2008 to May, 2019 will be included in retrospective arm. Patients, who will undergo HSCT from June, 2019
onwards will be included in prospective arm. 
 
ExclusionCriteria 
Details  Unrelated, Haplomatched or mismatched patient donor pairs will not be enrolled for the
study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with acute graft versus host disease.  From date of transplant to day 100 post transplant. 
 
Secondary Outcome  
Outcome  TimePoints 
Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with relapse free survival.  1 year post transplant 
Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with overall survival.  1 year post transplant 
Association of Next generation sequencing of Vitamin D receptor (VDR) gene polymorphisms in patients and donors with transplant related mortality.  1 year post transplant 
Correlation of VDR polymorphisms with vitamin (Vit.) D namely serum 25-hydoxyvitamin D3 and 1,25-dihydroxyvitamin D3 levels pre transplantation and the effect of VDR polymorphisms on the normalization of Vit D levels post supplementation  Pretransplant and 4 months from Vit. D supplementation. 
Immunomodulatory effect of Vit. D on the expression of the HLA gene in the patient post HSCT and its correlation with graft versus host disease.  1 year post transplant 
Immunomodulatory effect of Vit. D on Th1 Th2 cell subsets along with cytokines in the peripheral blood cytokines post HSCT and its correlation with graft versus host disease.  Day 100 post transplant  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   06/07/2021 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The action of vitamin D3 is mediated by vitamin D receptor (VDR). The VDR is expressed on both normal and cancerous blood cells.. Around 200 variations have been identified in the VDR gene. These variations affect the protein present in the human. Bone marrow transplantation (BMT) is used to treat patients with life threatening blood cancers. In transplantation group of proteins called HLA (human leukocyte antigen) located on the surface of white blood cells and other cells in the body must be shared between a patient and donor. The more the sharing the better is the transplant outcome. The study conducted at our centre suggests that low Vit.D levels post supplementation affects transplant outcomes. Since vitamin D3 binds to vitamin D receptor (VDR) we plan to study the VDR genetic forms along with HLA genes to understand their role in graft outcome post BMT.

A total of 200 patients/donors undergoing HLA matched sibling HSCT will be included in this study. Serum vitamin D3 levels is done by ELISA as a part of pre HSCT work up in all patients. Patients who have undergone (retrospective) as well as those who will be taken for HLA matched sibling HSCT (prospective) will be included for VDR and HLA genotyping. This will include patients/donors (n=100) who underwent HSCT between December 2008 to May 2020 in the retrospective arm. Patients/donors who will undergo HSCT from the time of study approval (n=100) onwards will be included in prospective arm. Representative patients/donors from the prospective arm (n=50) will be investigated for VDR expression analysis, lymphocyte subsets, cytokine levels and expression in peripheral blood.

 
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