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CTRI Number  CTRI/2019/06/019880 [Registered on: 26/06/2019] Trial Registered Prospectively
Last Modified On: 20/07/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to assess the usefulness of various tests done for the monitoring of long term complications in survivors of leukemia and lymphoma. 
Scientific Title of Study   A prospective observational cohort study to identify the utility of risk-based screening strategy for long term complications in adolescent and adult cancer survivors of leukemia and lymphoma. 
Trial Acronym  LTFU 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hasmukh Jain 
Designation  Associate Professor  
Affiliation  Tata Memorial Centre 
Address  Room No.81, Adult Haematolymphoid Deparment, Medical Oncology Division, Main Building, Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hasmukh Jain 
Designation  Associate Professor  
Affiliation  Tata Memorial Centre 
Address  Room No.81, Adult Haematolymphoid Deparment, Medical Oncology Division, Main Building, Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hasmukh Jain 
Designation  Associate Professor  
Affiliation  Tata Memorial Centre 
Address  Room No.81, Adult Haematolymphoid Deparment, Medical Oncology Division, Main Building, Tata Memorial Hospital, Dr.E Borges road, Parel Mumbai, 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177018  
Fax    
Email  dr.hkjain@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Research Administrative council, Clinical Research Secretariat, Main Building 3rd Floor, Tata Memorial Hospital Dr. E. Borges Road Parel, Mumbai- 400012 
 
Primary Sponsor  
Name  Tata Memorial Centre Research Administrative council 
Address  Tata Memorial Centre Research Administrative council, Clinical Research Secretariat, Main Building 3rd Floor, Tata Memorial Hospital, Dr. E.Borges Road, Parel, Mumbai 400012. 
Type of Sponsor  Research institution and hospital 
 
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 Hasmukh Jain  Tata Memorial Hospital  Room No. 81, Main Building, Ground Floor, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai, 400012
Mumbai
MAHARASHTRA 
02224177018

dr.hkjain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C950||Acute leukemia of unspecified celltype, (2) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (3) ICD-10 Condition: C930||Acute monoblastic/monocytic leukemia, (4) ICD-10 Condition: C920||Acute myeloblastic leukemia, (5) ICD-10 Condition: C926||Acute myeloid leukemia with 11q23-abnormality, (6) ICD-10 Condition: C92A||Acute myeloid leukemia with multilineage dysplasia, (7) ICD-10 Condition: C865||Angioimmunoblastic T-cell lymphoma, (8) ICD-10 Condition: C911||Chronic lymphocytic leukemia of B-cell type, (9) ICD-10 Condition: C931||Chronic myelomonocytic leukemia, (10) ICD-10 Condition: C914||Hairy cell leukemia, (11) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, (12) ICD-10 Condition: C813||Lymphocyte depleted Hodgkin lymphoma, (13) ICD-10 Condition: C814||Lymphocyte-rich Hodgkin lymphoma, (14) ICD-10 Condition: C91A||Mature B-cell leukemia Burkitt-type, (15) ICD-10 Condition: C812||Mixed cellularity Hodgkin lymphoma, (16) ICD-10 Condition: C810||Nodular lymphocyte predominant Hodgkin lymphoma, (17) ICD-10 Condition: C811||Nodular sclerosis Hodgkin lymphoma, (18) ICD-10 Condition: C91Z||Other lymphoid leukemia, (19) ICD-10 Condition: C85||Other specified and unspecified types of non-Hodgkin lymphoma, (20) ICD-10 Condition: C913||Prolymphocytic leukemia of B-celltype,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients previously treated for acute leukemia and lymphoma that are in complete remission.
2. Age more than or equal to 15 years at the time of inclusion into the study.
3. Those that have completed at least 2 years since their last therapy.
4. Willing to follow up at Tata Memorial Center, Mumbai. 
 
ExclusionCriteria 
Details  Those that have undergone or are planned for hematopoietic stem cell transplant.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients who test positive for any of the screening tests throughout the duration of follow up will be estimated.  12 months, 24 months, 36 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Yield of a subset of the twenty one diagnostic tests
2. Prevalence of a complication
3. To identify clinical and demographic factors associated with “high yield” tests.
 
12 months, 24 months, 36 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   05/07/2019 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet available. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Over the years there had been an improvement in the treatment of blood cancer due to better drugs and supportive care. However the drugs and the treatment regimen used are very intense. Current estimates suggest that nearly 3% of the general population is represented by cancer survivors.  The cancer survivors are vulnerable to late complications such as organ dysfunction, cardio toxicity, pulmonary dysfunction, cognitive impairment, endocrine complications, osteoporosis etc., gonad toxicity and second malignancies most commonly. Hence it is necessary to be followed up to detect the possible recurrence and complications. Long term follow up for cancer survivors has been neglected even in developed countries. The children’s oncology group (COG) developed a long term follow up guideline for childhood cancer survivors which have been in use from 2003. These guidelines identified the risk of long term complications based on the kind of drug doses and treatment individual patient received.  Landier et al performed an elegant cross-sectional study evaluating the yield and usefulness of risk adapted screening tests in survivors of childhood cancers. His findings can be used to refine COG guidelines and aid in the development of similar protocols. Monitoring strategy in adult cancer survivors are described only in a type of blood cancer known as Hodgkin’s Lymphoma (HL) with no published data on its usefulness in clinical practice. We propose to determine the effectiveness of the adapted COG LTFU Guidelines in identifying key long-term complications in adult cancer survivors of lymphoma and leukemia during routine follow-up care. We also hope to identify subpopulations that will benefit from high or low intensity screening .We hope the results of the study will aid in early identification of anticipated long-term complications such as thyroid dysfunction, premature menopause, breast cancer and infertility and avoid subjecting patients to tests that do not help identify the complications efficiently.

 
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