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CTRI Number  CTRI/2024/01/061792 [Registered on: 24/01/2024] Trial Registered Prospectively
Last Modified On: 21/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Biomarkers in Breast Cancer-microRNA profiling and Omics analysis 
Scientific Title of Study   MOLECULAR PROFILING OF MICRORNAS AS BIOMARKERS IN BREAST CANCER-INTEGRATED OMICS ANALYSIS IN TERTIARY CARE HOSPITAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poongkodi Karunakaran 
Designation  Assistant Professor of Endocrine Surgery 
Affiliation  Government Mohan Kumaramangalam Medical College 
Address  Endocrine Surgery OPD no 177, 3rd floor, PMSSY Superspeciality block, Government Mohan Kumaramangalam Medical College hospital campus

Salem
TAMIL NADU
636030
India 
Phone  9443119743  
Fax  0427-2383193  
Email  poongkodithesurgeon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Poongkodi Karunakaran 
Designation  Assistant Professor of Endocrine Surgery 
Affiliation  Government Mohan Kumaramangalam Medical College 
Address  Endocrine Surgery OPD 177, 3rd floor, PMSSY Superspeciality block, Government Mohan Kumaramangalam Medical College hospital campus

Salem
TAMIL NADU
636030
India 
Phone  9443119743  
Fax  0427-2383193  
Email  poongkodithesurgeon@gmail.com  
 
Details of Contact Person
Public Query  
Name  Poongkodi Karunakaran 
Designation  Assistant Professor of Endocrine Surgery 
Affiliation  Government Mohan Kumaramangalam Medical College 
Address  Endocrine Surgery OPD 177, 3rd floor, PMSSY Superspeciality block, Government Mohan Kumaramangalam Medical College hospital campus

Salem
TAMIL NADU
636030
India 
Phone  9443119743  
Fax  0427-2383193  
Email  poongkodithesurgeon@gmail.com  
 
Source of Monetary or Material Support  
Government Mohan Kumaramangalam Medical College 
 
Primary Sponsor  
Name  Government Mohan Kumaramangalam Medical College 
Address  Government Mohan Kumaramangalam Medical College campus, Steel plant road, Sarkar Kolapatty, Salem, Tamilnadu, PIN 636030 
Type of Sponsor  Government medical college 
 
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 Poongkodi Karunakaran MS MCh PhD  Government Mohan Kumaramangalam Medical College Hospital  Unit of Endocrine Surgery, Department of General Surgery, New Surgical block, PMSSY block, Government Mohan Kumarmangalam Hospital Campus
Salem
TAMIL NADU 		 9443119743
0427-2383193
poongkodithesurgeon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutinal Ethics Committee, Government Mohan Kumaramangalam Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Consecutive patients with newly detected breast cancer- planned for surgery (MRM or BCT) or Neo-adjuvant chemotherapy
2. Age and sex-matched subjects without breast cancer
 
 
ExclusionCriteria 
Details  1. Known case of Breast cancer previously treated with surgery, chemotherapy or radiotherapy
2. Previous history of treatment for non-breast cancer
3. Patients with unsound mind
4. Patients not willing  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Diagnostic microRNA in breast cancer patients versus healthy adults such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335
2. Prognostic microRNA in Breast Cancer such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335 		 1. Early Breast Cancer
Before Surgery
Before Adjuvant Chemotherapy
Before Adjuvant Radiotherapy
3-month post-chemoradiotherapy
2.Locally Advanced Breast cancer
Before neoadjuvant therapy
Before Surgery
Before Adjuvant Chemotherapy
Before Adjuvant Radiotherapy
3-month post-CRT
3. Metastatic Breast Cancer
Before and after palliative therapy

 
 
Secondary Outcome  
Outcome  TimePoints 
microRNA (miR) profile- Early BC markers-miR-16 and miR-106a, a miR-19b-based 3-circulating miRNA
miR profile - Invasive Breast Cancer-miR-12, miR-1246
miR profile- Triple negative breast cancer-miR-939
miR profile- Drug resistance - miR-451, miR-326, miR- 100, miR-222, and miR- 30a
miR profile- Poor prognosis- miR-155, miR-21, miR-1246, miR-let 7 family
miR profile- Diagnostic versus Prognostic markers- miR 155, miR-let 7 family
 		 1. Early Breast Cancer
Before Surgery
Before Adjuvant Chemotherapy
Before Adjuvant Radiotherapy
3-month post-chemoradiotherapy
2.Locally Advanced Breast cancer
Before neoadjuvant therapy
Before Surgery
Before Adjuvant Chemotherapy
Before Adjuvant Radiotherapy
3-month post-CRT
3. Metastatic Breast Cancer
Before and after palliative therapy

 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   05/02/2024 
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="2"
Months="6"
Days="21" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poongkodithesurgeon@gmail.com].

  6. For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  


Breast cancer (BC) is the most common cancer among women, with approximately 2.3 million new cases and over 685,000 deaths worldwide in 2020. India is no exception. Risk factors include age, genetics, and lifestyle choices. Challenges in India include relatively younger age of onset, late-stage diagnosis, limited access to quality healthcare in rural areas, and lack of awareness about symptoms and risk factors. Treatment options include surgery, chemotherapy, radiation, and hormonal therapies. Research on early detection and effective targeted therapies is the need of the hour to improve overall and disease-free survival rates.

MicroRNA (miR) profiling is a valuable tool in breast cancer research and clinical practice to analyse the expression levels of microRNAs (miRNAs) in breast cancer tissue. The role of miR profiling in breast cancer includes the following:

1.       Biomarker Discovery: MicroRNA profiling helps identify specific miRNAs that are either overexpressed or underexpressed in breast cancer tissue. These miRNAs can serve as potential biomarkers for diagnosis, prognosis, and predicting treatment responses.

2.       Molecular Subtyping: MicroRNA profiles can aid in classifying breast cancer into different molecular subtypes, such as luminal, HER2-enriched, and triple-negative. This classification is crucial for tailoring treatment strategies to the unique characteristics of the tumour.

3.       Prognostication: Certain miRNA expression patterns are associated with different outcomes in breast cancer patients. High or low expression of specific miRNAs can indicate a better or worse prognosis, assisting healthcare professionals in making informed treatment decisions.

4.       Identification of Therapeutic Targets: MicroRNA profiling can reveal miRNAs that play a significant role in cancer progression, metastasis, and drug resistance. Targeting these miRNAs with therapeutic interventions or drugs may offer new avenues for breast cancer treatment.

5.       Personalized therapies: By analysing a patient’s microRNA profile, personalized treatment strategies targeting the unique genetic characteristics of a patient’s breast cancer are possible, potentially leading to improved survival.

 
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