| CTRI Number |
CTRI/2024/03/064362 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Monoclonal Gammopathy of Undetermined Significance in Tamil Nadu, India: A Population-based Prospective Cohort Study
|
|
Scientific Title of Study
|
MGUS Epidemiology Study in 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 Nikita Mehra |
| Designation |
Associate Professor Grade 1 Medical Oncology and Researcher, Molecular Oncology |
| Affiliation |
Cancer Institute WIA Adyar |
| Address |
Cancer Institute (WIA)
Dr. S. Krishnamurthi Campus
38 Sardar Patel Road
Bhagwan Adinath Complex 3rd floor
Department of Molecular Oncology
Chennai
TAMIL NADU
600036
India |
| Phone |
04422209150 |
| Fax |
|
| Email |
m.nikita@cancerinstitutewia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Mehra |
| Designation |
Associate Professor Grade 1 Medical Oncology and Researcher, Molecular Oncology |
| Affiliation |
Cancer Institute WIA Adyar |
| Address |
Cancer Institute (WIA)
Dr. S. Krishnamurthi Campus
38 Sardar Patel Road
Bhagwan Adinath Complex 3rd floor
Department of Molecular Oncology
Chennai
TAMIL NADU
600036
India |
| Phone |
04422209150 |
| Fax |
|
| Email |
m.nikita@cancerinstitutewia.org |
|
Details of Contact Person
Public Query
|
| Name |
Ms Subhiksha Sundaram |
| Designation |
Project Technical Assistant Medical Oncology and Molecular Oncology |
| Affiliation |
Cancer Institute WIA Adyar |
| Address |
38 Sardar Patel Road
Bhagwan Adinath Complex 3rd floor
Department of Molecular Oncology
Chennai
TAMIL NADU
600036
India |
| Phone |
04422209150 |
| Fax |
|
| Email |
subhi.sundaram2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Sanmar Group CSR Trust |
|
|
Primary Sponsor
|
| Name |
Cancer Institute WIA Adyar Chennai |
| Address |
Dr S Krishnamurthi Campus
38 Sardar Patel Road
Bhagwan Adinath Complex 3rd floor
Department of Molecular Oncology
Chennai 600036 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikita Mehra |
Cancer Institute (WIA) |
38 Sardar Patel Road
Chennai 600036
Chennai
TAMIL NADU |
04422209150
m.nikita@cancerinstitutewia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Cancer Institute WIA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MGUS |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The participants will be included in the study after giving a signed written informed consent. |
|
| ExclusionCriteria |
| Details |
-Previous history of lymphoproliferative disorders such as Waldenström macroglobulinemia or chronic lymphocytic leukemia
-Non consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of MGUS in the community |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To identify epidemiological factors related to MGUS
•To validate MALDI-TOF mass spectrometry for M-protein analysis by the acetonitrile precipitation technique
|
3 years |
|
|
Target Sample Size
|
Total Sample Size="4100"
Sample Size from India="4100"
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)
|
01/04/2024 |
| 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="3"
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
|
Multiple myeloma is the second most common hematological malignancy and accounts for 10% of all the hematological malignancies. MGUS is an established precursor of multiple myeloma. Race is an important determinant in assessing the prevalence of MGUS. Several studies have shown a two to three-fold higher prevalence of MGUS among Africans and African Americans. The community prevalence of MGUS has not been reported from South Asia, including India. This study will provide important insights on the aetiopathogenesis of MGUS.
|