A study to assess the usefulness of various tests done for the monitoring of long term complications in survivors of leukemia and lymphoma.

Recruiting

• Registration Number: CTRI/2019/06/019880
• Lead Sponsor: Tata Memorial Centre Research Administrative council

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients previously treated for acute leukemia and lymphoma that are in complete remission.
• Age more than or equal to 15 years at the time of inclusion into the study.
• Those that have completed at least 2 years since their last therapy.
• Willing to follow up at Tata Memorial Center, Mumbai.

Exclusion Criteria

Those that have undergone or are planned for hematopoietic stem cell transplant.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
1.Yield of a subset of the twenty one diagnostic tests	2. Prevalence of a complication

Trial Locations

Locations (1)

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Memorial Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Dr Hasmukh Jain

Principal investigator

02224177018

dr.hkjain@gmail.com