| CTRI Number |
CTRI/2025/04/085799 [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 x chromosomes in cancer patients |
|
Scientific Title of Study
|
An observational study to estimate the prevalence of mLOX in women with hematological and solid malignancies |
| Trial Acronym |
mLOX study |
|
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 Dept of internal medicine Armed Forces Medical College
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| 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 Dept of Internal Medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| 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 |
8195035551 |
| 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 Dept of internal medicine Armed Forces Medical College Pune
Pune
MAHARASHTRA |
8195035551
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 |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed patients with multiple myeloma as per IMWG criteria are eligible for inclusion |
|
| ExclusionCriteria |
| Details |
premature ovarian failure
turner females
known sex chromosome disorders
hormone replacement therapy history
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate mosaic loss of X chromosome in women with hematological and solid malignancies |
Cross sectional study
Single time point evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to explore association between mLOX & age at onset of malignancies
To explore the association between mLOX age of menarche menopause in different malignancies |
baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Mosaic loss of x chromosome of mLOX is the phenomenon that may predict the loss of one copy of a woman’s two x chromosomes with age . The x chromosome inactivation has evolved as a mechanism to compensate for gene dosage imbalances between XX female and XY males , although some genes are only partially inactivated including the tumor suppressor genes(ATRX, KDM5C) . mLOX along with age related types of CH are important pre clinical indicators of hematological cancer risk and identify mitotic mis segregation , autoimmunity , blood cell trait and cancer pre disposition genes as core etiological components for mLOX susceptibility and selection. This study aims to estimate the mosaic loss of x chromosome in women with hematological and solid malignancies , to explore the association between mLOX and age of onset of malignancies and to explore association between mLOX , age of menarche/menopause in different malignancies |