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Clinical Trials/CTRI/2024/06/069213
CTRI/2024/06/069213
Not yet recruiting
Not Applicable

Late Mortality, Burden of Morbidity and Quality of Life in Long Term Survivors of Hematopoietic Cell Transplantation: Experience from A Single Centre in India

Advanced Centre for Treatment Research and Education in Cancer)1 site in 1 country154 target enrollmentStarted: July 2, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Advanced Centre for Treatment Research and Education in Cancer)
Enrollment
154
Locations
1
Primary Endpoint
Incidence of chronic health conditions

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Multiple myeloma.

Outcomes

Primary Outcomes

Incidence of chronic health conditions

Time Frame: 2 years

Secondary Outcomes

  • -Incidence and cause of mortality(-Assessment of functional status and fertility)

Investigators

Sponsor
Advanced Centre for Treatment Research and Education in Cancer)
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Nishant Jindal

Advanced Centre for Treatment Research and Education in Cancer

Study Sites (1)

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