| CTRI Number |
CTRI/2024/04/066088 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identifying bladder problems and the risk factors in children with cancer undergoing chemotherapy - A Prospective Study |
|
Scientific Title of Study
|
Lower Urinary Tract Dysfunction in Childhood Cancer Survivors - A Prospective Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi PM |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Pediatric Hematology and Oncology, Kasturba Medical College, Manipal
Tiger circle road
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
swathipm1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Pediatric Hematology and Oncology, Kasturba Medical College, Manipal
Tiger circle road
Udupi
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasudeva Bhat K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Division of Pediatric Hematology and Oncology, Kasturba Medical College, Manipal
Tiger circle road
KARNATAKA
576104
India |
| Phone |
9619114703 |
| Fax |
|
| Email |
vasudev.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swathi PM |
| Address |
Division of Pediatric Hematology and Oncology, kasturba Medical College, Manipal |
| Type of Sponsor |
Other [self] |
|
|
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 Swathi PM |
Kasturba Hospital, Manipal |
Room No: 14, Department of hemato-oncology, Kasturba Hospital, opp Tiger circle road, Manipal, 576104
Udupi
KARNATAKA |
9886591118
swathipm1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Survivors of childhood cancer
2.Age ≥ 5 years
3.Parents/guardians providing informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Survivors with congenital Genito urinary malformations, Genetic syndromes, spinal defects, and neurologic disorder
2.Parents who refuse to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between chemotherapeutic agents and their cumulative dose with development of LUTDS |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessing the risk factors for LUTD in cancer survivor children on chemotherapy |
6 months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
30/04/2024 |
| 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="1"
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
|
Chemotherapeutic agents commonly used in childhood cancer therapy may also cause long-term adverse effects, including lower urinary tract dysfunction (LUTD). LUTD can impact bladder function and lead to urinary incontinence, frequency, urgency, or difficulty in voiding. Despite several studies reporting a high prevalence of LUTD in childhood cancer survivors, the risk factors and optimal management strategies are not fully understood. This study aims to prospectively evaluate the prevalence, severity, risk factors, and management strategies of LUTD in childhood cancer survivors. |