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CTRI Number  CTRI/2024/04/065047 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 31/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Cluster Randomized Trial 
Public Title of Study   CLINICAL Correlation Between Breast Cancer And Prognostic Significance Of Ferritin, Vitamin D AND Vitamin B12 
Scientific Title of Study   Clinical correlation between breast cancer and prognostic significance of ferritin,vitamin D and vitamin B12.  
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 Akansha Hatewar 
Designation  Junior Resident  
Affiliation  Datta Meghe Institute Of Higher Education And Research 
Address  Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College, DMIHER, Sawangi, Wardha
Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College, DMIHER, Sawangi, Wardha
Wardha
MAHARASHTRA
442004
India 
Phone  8381048570  
Fax    
Email  akanshahatewar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekhar Mahakalkar 
Designation  Professor,Department Of General Surgery  
Affiliation  Datta Meghe Institute Of Higher Education And Research 
Address  Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha
Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha
Wardha
MAHARASHTRA
442004
India 
Phone  9822369277  
Fax    
Email  cmahakalkar@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandrashekhar Mahakalkar 
Designation  Professor,Department Of General Surgery  
Affiliation  Datta Meghe Institute Of Higher Education And Research 
Address  Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha
Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha
Wardha
MAHARASHTRA
442004
India 
Phone  9822369277  
Fax    
Email  cmahakalkar@rediffmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute Of Higher Education And Research,Sawangi Meghe,Wardha, Maharashtra 
 
Primary Sponsor  
Name  Akansha Hatewar 
Address  Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha,Maharashtra,442004 
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akansha Hatewar  Acharya Vinobha Bhave Rural Hospital,Wardha  Department Of General Surgery, AVBRH Hospital, Jawaharlal Nehru Medical College,DMIHER Sawangi, Wardha,Maharashta
Wardha
MAHARASHTRA 		 8381048570

akanshahatewar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Female 
Details  1 Newly diagnosed case of CA breast and biopsy proven.
2 Women aged above 18 years.
 
 
ExclusionCriteria 
Details  1 Malignancies other than breast carcinoma
2 Pregnancy/puerperium
3 Known c/o Tuberculosis, Chronic inflammatory diseases
4 Patients infected with hepatitis B and C virus as well as H.I.V.
5 Renal/Hepatic insufficiency
6 Metabolic bone disorders
7 No history of medications such as iron, levothyroxine and vitamin D/B12 supplements in the past three months
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1 To estimate levels of serum vit D, Vit B12, and Ferritin in patients with stages of breast cancer.
2 To analyse a correlation between serum vit D, Vit B12, Ferritin with Tumour grade, histopathological subtype and axillary lymph node status.
3 To correlate between serum vit D, Vit B12, and Ferritin with molecular pathological parameters.
 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. In this study we aim to conduct a comprehensive analysis by comparing serum expression levels of vitamin B12 vitamin D & ferritin among three distinct groups healthy individuals patients with benign breast conditions & those diagnosed with breast cancer.
2. Our primary focus is to assess the intricate relationship between vitamin B12 vitamin D & ferritin levels & the associated risk of breast cancer.
 		 2 years 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   10/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
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  

In this study, we aim to conduct a comprehensive analysis by comparing serum expression levels of vitamin B12, vitamin D, and ferritin among three distinct groups: healthy individuals, patients with benign breast conditions, and those diagnosed with breast cancer. Our primary focus is to assess the intricate relationship between vitamin B12, vitamin D, and ferritin levels and the associated risk of breast cancer. By examining these parameters across various health conditions, we intend to gain a deeper understanding of how these vitamins may play a pivotal role in breast cancer risk. This research holds the potential to shed valuable light on the connections between these serum markers and the development of breast cancer, ultimately contributing to our knowledge of this complex disease.

 
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