| CTRI Number |
CTRI/2025/10/095989 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Type 2 Diabetes mellitus and Cancer |
|
Scientific Title of Study
|
Association between Type 2 Diabetes mellitus and Cancer: A case control study”
|
| 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 Kaushik SN |
| Designation |
Postgraduate student |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Nehru Nagar ,Belagavi ,Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9480322471 |
| Fax |
|
| Email |
kaushiksunti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kambar |
| Designation |
Professor |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Nehru Nagar ,Belagavi ,Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9886475864 |
| Fax |
|
| Email |
sanjaykambar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushik SN |
| Designation |
Postgraduate student |
| Affiliation |
KAHER Jawaharlal Nehru Medical College |
| Address |
Department of Community Medicine, Jawaharlal Nehru Medical College, Nehru Nagar ,Belagavi ,Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9480322471 |
| Fax |
|
| Email |
kaushiksunti@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Jawaharlal Nehru Medical College Belagavi Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr KAUSHIK SN |
| Address |
Department of Community Medicine Jawaharlal Nehru Medical College Nehru Nagar Belagavi Karnataka 590010 |
| Type of Sponsor |
Other [SELF] |
|
|
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 KAUSHIK SN |
KAHER Jawaharlal Nehru Medical College |
Department of Community Medicine Jawaharlal Nehru Medical College Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA |
09480322471
kaushiksunti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients newly diagnosed with cancer and confirmed by biopsy visiting the Medical oncology Outpatient Department of KLE Dr. Samaptkumar S. Shivanagi Cancer Hospital will be taken as cases .For controls, one control without cancer visiting Hospital for other reasons and another control without cases from the field practise area of urban Belagavi community by matching age and sex with the cases. |
|
| ExclusionCriteria |
| Details |
1) All type 1 diabetes patients
2) Blood Cancers
3) Brain Cancers
4) Pancreatic Cancers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between diabetes and cancer. |
50 weeeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between other risk factors and cancer |
50 weeeks |
|
|
Target Sample Size
|
Total Sample Size="390"
Sample Size from India="390"
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)
|
27/10/2025 |
| 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="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 present study is
conducted among cancer patients with or without Type 2 diabetes mellitus(T2DM) registered
in Medical Oncology Outpatient Department of KLE Dr.
Samaptkumar S. Shivanagi Cancer Hospital , patients visiting hospital for other reasons and
patients of field practise area of urban Belagavi community to determine the association between
diabetes and cancer. Considering
ratio
of cases: controls as 1:2 ,
All cancer patients visiting Medical Oncology
Outpatient Department of KLE Dr. Samaptkumar S. Shivanagi Cancer Hospital will
be considered as cases and for controls, one control without cancer visiting Hospital for other reasons and another control without cases from the field practise area of urban Belagavi community by matching age and sex with the cases.
A pilot study will be conducted after obtaining
Institutional Ethical clearance and required modifications will be done to the
questionnaire.
After obtaining the consent, pretested and pre
validated questionnaire will be used to do a personal interview for every
patient. Reports of diagnosis of cancer will be collected from the patient.
FBS/RBS and HbA1c tests will be done as and when required.
|