| CTRI Number |
CTRI/2025/10/096482 [Registered on: 27/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Type 2 Diabetes on Breast cancer outcomes: A Retrospective study |
|
Scientific Title of Study
|
Comparison of Breast cancer outcomes in patients with and without Type 2 Diabetes: A Retrospective cohort 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 |
Nivedita Anand |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7338170123 |
| Fax |
|
| Email |
nivi.anand813@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopa Satyanarayan Basutkar |
| Designation |
Assistant Professor G-III |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9047155003 |
| Fax |
|
| Email |
roopa.satyanarayan@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa Satyanarayan Basutkar |
| Designation |
Assistant Professor G-III |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9047155003 |
| Fax |
|
| Email |
roopa.satyanarayan@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University) Deralakatte, Mangaluru, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Other [Educational Institution] |
|
|
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 Krishna Sharan |
Justice K S Hegde Charitable Hospital |
Department of Oncology, Deralakatte, Mangaluru - 575018
Dakshina Kannada
KARNATAKA |
9448625116
drkrishna.sharan@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged above 18 years
Patients with all stages and grades of Breast Cancer
|
|
| ExclusionCriteria |
| Details |
Patients with Type 1 Diabetes Mellitus.
Patients with other malignancies.
Patients with unusual histologies, such as phyllodes tumor, sarcomas, etc.
Patients with missing HbA1c values on follow-up, receptor status
Patients lost to follow-up after diagnosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will compare the breast cancer outcomes such as survival, rehospitalization, recurrence, metastasis among Type 2 Diabetes and non-Type 2 Diabetes patients. |
Baseline is at the time of diagnosis, then every three months until the end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will assess the various factors that influence the breast cancer outcomes. Factors influencing Breast cancer outcome include:
Age
Comorbidities
Hormone receptor status (ER, PR, HER2)
Tumour stage, grade, size, position
Menopausal status
Lymph node status
Breast cancer treatment |
Baseline is at the time of diagnosis, then every three months until the end of treatment. |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
10/11/2025 |
| 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
|
INTRODUCTION Breast cancer is the most commonly diagnosed cancer worldwide, with 2.3 million new cases annually. In India, it accounts for about 13.5% of all cancer cases, with survival rates sharply decreasing as the disease progresses. Poor outcomes in India are linked to late diagnosis, younger age at onset, delayed treatment, and inadequate care. Type 2 Diabetes, affecting over 77 million people in India, shares common risk factors with breast cancer, such as obesity and aging. Diabetes may lead to more aggressive breast cancer due to elevated insulin and blood sugar levels, which activate tumour-promoting pathways (PI3K/Akt/mTOR). Chronic inflammation, hormonal imbalances, and metabolic disruptions further connect the two diseases. OBJECTIVES OF THE STUDY To compare the breast cancer outcomes such as survival, rehospitalization, recurrence, metastasis among Type 2 Diabetes and non-Type 2 Diabetes patients. To assess the effects of breast cancer treatment on changes in HbA1c levels and anti-diabetic medication therapy among the breast cancer patients with Type 2 Diabetes. To assess the various factors that influence the breast cancer outcomes. JUSTIFICATION FOR THE STUDY This study is crucial for evaluating patient outcomes by assessing the factors associated with DM and breast cancer and finding a potential link between the two. Comparing outcomes between these groups is important as T2DM may worsen prognosis through metabolic disturbances, chronic inflammation, and treatment limitations. Evaluating the association between clinicopathological features such as tumour characteristics and hormone receptor status with patient outcomes will guide treatment decisions. Assessing how breast cancer treatment affects glycemic control and the need for changes in antidiabetic medication is essential, as therapies like chemotherapy and corticosteroids can disrupt glucose regulation. Ultimately, this research seeks to improve patient outcomes and elevate the overall understanding of importance of glycemic control in such patients. METHODOLOGY A retrospective cohort study will be conducted for six months, from September 2025 to February 2026. The data of the inpatients diagnosed with breast cancer will be collected from MRD for the time period, January 2014 to December 2023. A properly designed data collection form will be used to gather patient information. The patients are enrolled based on the inclusion criteria. Breast cancer patients will be categorized into two groups, patients diagnosed with Type 2 Diabetes; patients not diagnosed with Type 2 Diabetes. The factors associated with breast cancer and Type 2 Diabetes will be determined. STATISTICAL ANALYSIS Quantitative data will be expressed as mean ± SD or median (IQR). Qualitative data will be expressed as frequency and percentage. Chi-square test or Fisher’s exact test will be used to find association between categorical variables. Kaplan-Meier plots will be used to compare the events occurring in two groups. Cox proportional hazard models will be constructed to find the factors associating the events occurring in the groups. SPSS software version 29 will be used for statistical analysis. p<0.05 will be considered statistically significant. OUTCOME MEASURES | Breast Cancer Outcomes | | Survival | | Recurrence and Time to Recurrence | | Rehospitalization for other complications | | Metastasis and Time to Metastasis | | Factors influencing Breast cancer outcomes | | Demographic characteristics: Age | | Comorbidities | | Hormone receptor status (ER, PR, HER2) | | Tumour stage, grade, size, position | | Menopausal status | | Lymph node status | | Breast cancer treatment | |