| CTRI Number |
CTRI/2025/04/085798 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A cross sectional study on loss of sex chromosomes in myeloma patients |
|
Scientific Title of Study
|
An observational study on loss of sex chromosomes in myeloma patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uday Yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Room no 10 Department of internal medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
08195035551 |
| Fax |
|
| Email |
udayj2yanamandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Uday Yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Room no 10 Department of internal medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
08195035551 |
| Fax |
|
| Email |
udayj2yanamandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uday Yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Room no 10 Dept of internal medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
08195035551 |
| Fax |
|
| Email |
udayj2yanamandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARMED FORCES MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Pune Sholapur Highway
Pune
Maharashtra 411040 |
| 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 |
| Uday Yanamandra |
AFMC |
Room no 10 Department of internal medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA |
08195035551
udayj2yanamandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
myeloma patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the loss of Y chromosomes in male and X chromosomes in female patients of myeloma |
Cross sectional study
Single time point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
10/05/2025 |
| 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="0"
Months="6"
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
|
Genetic instability is a key characteristic in cells of myeloma. The loss of sex chromosomes, such as the loss of one X chromosome in females or abnormalities in the X or Y chromosomes in males could lead to genetic instability. The loss of sex chromosomes often occurs alongside other genetic mutations or chromosomal abnormalities, such as changes in the genes responsible for regulating the immune system or blood cell production. This combination of genetic changes can increase the risk of developing multiple myeloma. The loss of sex chromosomes might also have different implications based on gender. In women, the loss of an X chromosome (a phenomenon known as mosaic loss of X chromosomes) can lead to changes in gene expression that may affect immune system function and contribute to diseases like myeloma. In men, the loss of the Y chromosome or changes in the X chromosome might have a similar impact on immune function and cell regulation, potentially influencing cancer risk .In view of the above this study aims to understand the pattern of loss of sex chromosomes in patients of myeloma. Patients who fulfil the inclusion criteria are selected after taking informed written consent. Male patients are tested for loss of Y chromosomes and female patients for loss of X chromosomes by FISH (fluorescent in situ hybridization on interphase cells, lymphocytes of peripheral blood sample).The blood samples will be collected from the OPD setup and will be analyzed at AFMC. (2ml of heparin sample)Prestructured, pretested and validated proforma will be used for data collection |