| CTRI Number |
CTRI/2024/06/068488 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Risk Factors for Blood Cancer in Wardha |
|
Scientific Title of Study
|
Assessing the Risk Factors for the occurrence of Blood Cancer in Wardha |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjana Wankhade |
| Designation |
Post graduation student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Health Science,Datta Meghe Institute of Higher Education and Research Sawangi Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
7057995308 |
| Fax |
|
| Email |
sanjanawankhade4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Gaurav Mude |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Health Science Datta Meghe College of Pharmacy Salod
Wardha MAHARASHTRA 442001 India |
| Phone |
8007095656 |
| Fax |
|
| Email |
gaurav.pharmacy@dmiher.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Gaurav Mude |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Health Sciences,Datta Meghe College of Pharmacy Salod Wardha
MAHARASHTRA 442001 India |
| Phone |
8007095656 |
| Fax |
|
| Email |
gaurav.pharmacy@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Datta meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe |
| 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 |
| Sanjana Wankhade |
Siddharth Gupta Memorial Cancer Hospital, Sawangi Wardha. |
Datta Meghe Institute of Higher Education and Research Sawangi Wardha MAHARASHTRA |
7057995308
sanjanawankhade4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D728||Other specified disorders of whiteblood cells, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
65.00 Month(s) |
| Gender |
Both |
| Details |
Patients of Blood Cancer
|
|
| ExclusionCriteria |
| Details |
General Population
Above 65 not allowed
Children not allowed
Others cancer patients not allowed
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We expect to find a high level of blood cancer patients and having high level risk factor siddharth gupta memorial cancer hospital Factors such as stage of life instruction, diet and heredity of blood cancer may be associated with blood cancer patients |
Assessment will be done in 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
17/07/2024 |
| 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="1" 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
|
Blood cancers, including leukaemia, lymphoma, and myeloma, are a diverse group of hematologic malignancies characterized by the abnormal growth of blood cells. environmental issues on a daily basis the contamination of air, water, and soil demands millions of years for recovery According to GLOBOCAN 2018 estimate there were 44,235 new patient and 15,222 loss of life worldwide. Carcinoma, is a multifaceted, diverse, assertive, and devastating disease, claiming the lives of millions worldwide. According to GLOBOCAN estimates, the year 2018 saw a staggering 18.1 million new cases and 9.6 million deaths
|