| CTRI Number |
CTRI/2024/05/067812 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Heavy metal in cytopenias |
|
Scientific Title of Study
|
A explorative study to asses the prevalence of heavy metal level abnormalities in patient presenting with unexplained cytopenia/low risk to a tertiary care hospital in North India |
| 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 Kartikey Saini |
| Designation |
SR DM |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Hematology All India Institute of Medical Sciences Delhi
South
DELHI
110049
India |
| Phone |
9799789859 |
| Fax |
|
| Email |
kartikeysaini0405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukul Aggarwal |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Hematology All India Institute of mMdical Sciences New Delhi
South
DELHI
110049
India |
| Phone |
8800898282 |
| Fax |
|
| Email |
mukulmamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartikey Saini |
| Designation |
SR DM |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Hematology All India Institute of medical sciences Delhi
DELHI
110049
India |
| Phone |
9799789859 |
| Fax |
|
| Email |
kartikeysaini0405@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES DELHI,India pincode 110049 |
| None |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
AIIMS Delhi, Ansari Nagar Delhi, India,Pincode 110049 |
| 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 Kartikey Saini |
All India Institute of Medical Sciences Delhi |
Room no 201, Department of Hematology,2nd floor New Private Ward, All India Institute of medical sciences Delhi
South
DELHI |
9799789859
kartikeysaini0405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for PG research AIIMS DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D538||Other specified nutritional anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patient satisfying who criteria for cytopenia |
|
| ExclusionCriteria |
| Details |
Patient with abnormal cytogenetics,NGS, pregnant, greater than 5% blast in bone marrow, pregnant female, organ dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of heavy metal level abnormalities in patient with unexplained cytopenia’s and low blasts MDS |
BASELINE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of supplementation/chelation in patients with cytopenia with heavy metal abnormalities. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="207"
Sample Size from India="207"
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)
|
31/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/05/2024 |
| 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
|
Open label prospective trial to asses the prevalence of heavy metal levels in patients presenting with unexplained although heavy metal lebel abnormalities have been described in mds and in unexplained cytopenias. The prevalence of the same is not known. Some of the these patients undergo chemotherapy after diagnosis of MDS, through our study we want to establish the prevalence and also prevention from the potential harmful therapy |