| 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
|
|
|
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
|
|
|
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. |