| CTRI Number |
CTRI/2021/08/035398 [Registered on: 04/08/2021] Trial Registered Prospectively |
| Last Modified On: |
31/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Chronic Myeloid Leukemia |
|
Scientific Title of Study
|
Clinico-hematological profile of chronic myeloid leukemia in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reetika Ramanathan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba hospital manipal |
| Address |
Department of General Medicine
Kasturba Hospital Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09980201069 |
| Fax |
|
| Email |
reetikar7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHUBHA SHESHADARI |
| Designation |
PROFESSOR |
| Affiliation |
Kasturba hospital manipal |
| Address |
Department of General Medicine
Kasturba Hospital
Manipal
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845563799 |
| Fax |
|
| Email |
shubhamanipal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Reetika Ramanathan |
| Designation |
Junior Resident |
| Affiliation |
Kasturba hospital manipal |
| Address |
Department of General Medicine
Kasturba Hospital Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
09980201069 |
| Fax |
|
| Email |
reetikar7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Kasturba Hospital
Manipal
576104 |
|
|
Primary Sponsor
|
| Name |
DRREETIKA RAMANATHAN |
| Address |
D-1005 KASTURBA HOSPITAL MANIPAL 576104 |
| 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 |
| Reetika Ramanathan |
KASTURBA HOSPITAL |
Department of General Medicine
Kasturba Hospital Manipal 576104
576104
Udupi
KARNATAKA |
9980201069
reetikar7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C921||Chronic myeloid leukemia, BCR/ABL-positive, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed cases of CML. 2.Follow up cases of CML
|
|
| ExclusionCriteria |
| Details |
1.Patients who are unwilling to give written informed consent.
2.Patients lost to follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients will be categorized into various CML phases based on WHO criteria and stratified into risk Scores based on prognostic scoring system.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinico-hematological response of follow up patients will be assessed.
(for 3-6 months whenever possible).
|
3-6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/08/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Newly diagnosed and
follow up cases of CML under Department of General Medicine and medical oncology in Manipal will be included in
the study. Demographic
details,clinical,laboratory findings will be collected and entered in the
proforma. Patients will be categorized into various CML phases
based on WHO criteria and stratified into risk scores based on prognostic scoring system.(SOKAL,HASFORD,EUTOS). Clinico-hematological
response of follow up patients will be assessed.(for 3-6 months
whenever possible). |