| CTRI Number |
CTRI/2024/06/069213 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study of a retrospective cohort. |
| Study Design |
Other |
|
Public Title of Study
|
A prospective observational study to assess the incidence of chronic health conditions and quality of life in patients who have undergone stem cell transplantation
|
|
Scientific Title of Study
|
Late Mortality, Burden of Morbidity and Quality of Life in Long Term Survivors of Hematopoietic Cell Transplantation: Experience from A Single Centre in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol no 901033 Version 2.0 dated 19.03.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishant Jindal |
| Designation |
Associate Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer |
| Address |
BMT OPD Room No 306,307 shanti sadan building Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8437600177 |
| Fax |
|
| Email |
drnishantjindal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Jindal |
| Designation |
Associate Professor |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer |
| Address |
BMT OPD Room No 306,307 shanti sadan building Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8437600177 |
| Fax |
|
| Email |
drnishantjindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bishal Sharma |
| Designation |
Senior resident |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer |
| Address |
BMT OPD room no 306,307 shanti sadan building sector 22, utasv chowk CISF Rd ,Owe camp, Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
02227408657 |
| Fax |
|
| Email |
bishals28101993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funding Not Applicable as this is a observational study Infrastructure support Advanced Centre for Treatment, Research and Education in Cancer Sector 22, Utsav Chowk -CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210 |
|
|
Primary Sponsor
|
| Name |
Advanced Centre for Treatment Research and Education in Cancer) |
| Address |
Owe camp, Sector 22, Kharghar, Navi Mumbai Raigarh 410210 |
| 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 Nishant Jindal |
Advanced Centre for Treatment Research and Education in Cancer |
BMT OPD, Room No 307, Shanti Sadan building
Raigarh
MAHARASHTRA |
8437600177
drnishantjindal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C969||Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified, (2) ICD-10 Condition: Z946||Bone transplant status, (3) ICD-10 Condition: D619||Aplastic anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
-Patients who underwent transplant autologous or allogeneic at ACTREC between 1st July 2007 and 30th June 2013
-Malignant hematological disorders and aplastic anemia
-Survived for more than 2 years with or without relapse of underlying disease
-Willing to provide an informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of chronic health conditions
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Incidence and cause of mortality
-Assessment of functional status and fertility
-Assessment of quality of life (QoL)
-Comparison of chronic health conditions, functional status, fertility and QoL between survivors of autologous and allogeneic BMT
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
02/07/2024 |
| 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="2"
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
|
Hematologic stem cell transplantation (HCT)
remains the only curative option for many malignant and non-malignant
hematologic disorders. However, relapse, infection, graft versus host disease,
endocrinopathies and second malignancies
are important cause of mortality and long term morbidity in these patients. Survivors
of HCT also face significant social and economic hardships post-transplant.
There is limited information on outcomes of long term survivors of HCT from
India. With the rising number of transplants being done across the country, it
is important to study the incidence and cause of late mortality, burden of
morbidity, functional rehabilitation and quality of life after HCT in our
patients. In this observational study, long term survivors who underwent HCT at
ACTREC will be interviewed about their physical and social well-being. The
study participants will not be subjected to any additional follow up visits,
investigations or treatment as part of this study. Information obtained from
this study might help the healthcare
providers and policy makers understand the burden of morbidity and mortality
post-transplant and in the allocation of resources towards the long-term care
of HCT survivors
In this study, we look at the long term
outcomes of patients who underwent autologous or allogeneic transplant at our
center and survived for more than 2 years post-transplant.
|