| CTRI Number |
CTRI/2026/01/102270 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
Identifying which immune cells are present in blood cancers and how many of each type there are. |
|
Scientific Title of Study
|
Identification and quantification of circulating myeloid derived suppressor cells in myeloid malignancies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kritika upadhyay |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
room number 54 Department of pathology ,pathology block Maulana Azad medical College, 2 Bahadur shah Zafar Marg
Central Delhi
110002
INDIA
Central
DELHI
110002
India |
| Phone |
8368250706 |
| Fax |
|
| Email |
kritikaup05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Arora |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
room number 54 Department of pathology ,pathology block Maulana Azad medical College, 2 Bahadur shah Zafar Marg
Central Delhi
Central
DELHI
110002
India |
| Phone |
09999952113 |
| Fax |
|
| Email |
drprernaarora27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Arora |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
room number 54 Department of pathology ,pathology block Maulana Azad medical College, 2 Bahadur shah Zafar Marg
Central Delhi
Central
DELHI
110002
India |
| Phone |
09999952113 |
| Fax |
|
| Email |
drprernaarora27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College , 2 Bahadur Shah Zafar Marg, New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
2 , Bahadur Shah Zafar Marg , New Delhi 110002 |
| Type of Sponsor |
Government 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 |
| Dr Kritika Upadhyay |
Maulana Azad Medical College |
Room number 54 department of pathology pathology block
Maulana Azad medical college
Bahadur Shah Zafar road 110002
Central
DELHI |
8368250706
kritikaup05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.I.P.M.E.R., Guru Nanak Eye Centre, New Delhi -110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
For cases - newly diagnosed cases of myeloid malignancies in male or female patients more that or equal to 18 years of age
For control - healthy controls equal to above 18 years of age |
|
| ExclusionCriteria |
| Details |
For cases - patients on treatment for myeloid malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome-proportion of circulating MDSCs. In patients of myeloid malignancies by flow cytometry
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome - quantification of circulating PMN -MDSCs ,Mo-MDSCsand e - MDSCs in patients of myeloid malignancies and healthy controls
Association of circulating PMN-MDSCs ,Mo-MDSCs and e-MDSCs with clinicopathological parameters in myeloid malignancies |
Baseline |
|
|
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)
|
14/02/2026 |
| 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
|
The goal is to identify and quantify specific mdsc populations in myeloid malignancies Total of 40 cases comprising of 20 normal controls and 20 cases of myeloid malignancies of ages 18 and above of both genders will be enrolled .their peripheral blood sample will be taken with consent and further flow cytometry will be done on these samples with a specicf panel for identifying the specific mdsc population. The data obtained will be analysed using statistical analytics tools such as SPSS software 25 And the result will be compiled and any association will be identified |