| CTRI Number |
CTRI/2024/05/067726 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dignosis of blood cancer using bone marrow aspiration. |
|
Scientific Title of Study
|
Assessment of parameters used for diagnosis of leukemia: An observational blindfold technique. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Payal Nandakishor Girade |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Reasearch |
| Address |
Dept. of Pathology 2nd floor JNMC Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7350887304 |
| Fax |
|
| Email |
payalgirde77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Rathod |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Reasearch |
| Address |
Dept. of Pathology 2nd floor JNMC Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579399870 |
| Fax |
|
| Email |
divyarathod710@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Rathod |
| Designation |
Senior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Reasearch |
| Address |
Dept. of Pathology 2nd floor JNMC Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9579399870 |
| Fax |
|
| Email |
divyarathod710@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya Vinoba Bhave Rural Hospital, Sawangi Wardha india |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Reasearch |
| Address |
Sawangi, Wardha Maharastra India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Payal N Girade |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Pathology 2nd Floor JNMC Building Sawangi, 442001
Wardha
MAHARASHTRA |
7350887304
payalgirde77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D729||Disorder of white blood cells, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age range 10-65 year old.
2.Patients who recently having fatigue and weakness and bone pain.
3.Patients experience sudden weight loss. |
|
| ExclusionCriteria |
| Details |
1.Recently blood transfusion individuals.
2.Immuno-compromised individuals.
3.Persons on medication that affects white blood cells (WBCs) funcation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation of Complete blood count and associated complications in leukemia patients.
|
Assessment will done 12 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Leukemia is a broad category of hematologic cancers that are brought on
by the abnormal proliferation of leukocytes during their development. Acute or
chronic myelocytic or lymphocytic conditions can be distinguished based on the
rate of proliferation and the original cell type.
Due to its elusive nature and varied presentation, rare and enigmatic
hematologic malignancy presents significant challenges in both diagnosis and
treatment. Proactive efforts to prevent leukemia have been hindered by the
inability to identify critical risk factors. This study aims to assess parameters used for diagnosis of Leukemia . |