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
|
|
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
|
|
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. |