| CTRI Number |
CTRI/2025/04/085136 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Correlation between Nottingham Prognostic Index and Receptor status in breast cancer patients undergoing surgery |
|
Scientific Title of Study
|
Hormone Receptor Status and Its Correlation with Nottingham Prognostic Index in Surgically Treated Breast Cancer Patients |
| Trial Acronym |
NOPROREST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shantanu Kumar Sahu |
| Designation |
Professor |
| Affiliation |
AII India Institute Of Medical Sceince, Bhubaneswar |
| Address |
Room no 63, AIIMS Department of General Surgery, Ground floor.
Khordha
ORISSA
751019
India |
| Phone |
8218053761 |
| Fax |
|
| Email |
surg_shantanu@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun S M |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, BBSR |
| Address |
Room no 63, Department of General Surgery, AIIMS Hospital Ground floor
Khordha
ORISSA
751019
India |
| Phone |
7337842616 |
| Fax |
|
| Email |
varungowdasm8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun S M |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, BBSR |
| Address |
Room no 63, Department of General Surgery, AIIMS Hospital Ground floor
ORISSA
751019
India |
| Phone |
7337842616 |
| Fax |
|
| Email |
varungowdasm8@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institution of Medical Science, Bhubaneswar, India , 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS, BBSR |
| Address |
AIIMS BBSR, Sijua, Patrapada, Bhubaneswar- 751019 |
| Type of Sponsor |
Government medical college |
|
|
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 Varun SM |
All India Institute of Medical Science, Bhubaneswar |
Room no 63 , Department of General Surgery, AIIMS BBSR, Sijua, Patrapada, Bhubaneswar, Odisha- 751019
Khordha
ORISSA |
7337842616
varungowdasm8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS BBSR |
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, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Carcinoma breast patients undergoing MRM
2. Carcinoma breast undergoing BCS+ALND |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing BCS+SLND |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between Nottingham prognostic index and receptor status in breast cancer undergoing surgery |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the changes in hormonal receptor status after administration of NACT |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
29/04/2025 |
| 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="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
|
Breast cancer is one of the most common malignancies affecting women globally, accounting for a significant portion of cancer-related morbidity and mortality (1). Advances in early detection and treatment modalities have contributed to improved survival rates, yet the prognosis and outcomes remain highly variable among patients.
To stratify breast cancer patients and predict outcomes, various prognostic tools have been developed, among which the Nottingham Prognostic Index (NPI) is widely utilized (2) .The NPI incorporates three key variables: tumor size, lymph node involvement, and histological grade. It provides a quantitative framework to categorize patients into different prognostic grade, guiding therapeutic decision-making (3).
In recent years, there has been increasing interest in understanding the relationship between the NPI and receptor status in breast cancer patients. Hormone receptors, including estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2), play pivotal roles in tumor biology and are critical biomarkers for determining treatment strategies. ER and PR positivity typically indicate a more favorable prognosis and responsiveness to endocrine therapy, while HER2 positivity often correlates with more aggressive tumor behavior but is amenable to targeted therapies (4), (5).
The interplay between NPI and receptor status is of particular clinical significance. While the NPI provides a composite assessment of tumor burden and biological aggressiveness, receptor status reflects the underlying molecular characteristics of the tumor (6). Understanding the correlation between these two factors could enhance the accuracy of prognostication, enabling personalized treatment plans. For instance, patients with low NPI scores but HER2-positive tumors may require more intensive management than those with similar scores but hormone receptor-positive, HER2-negative profiles.
This study aims to explore the correlation between the NPI and receptor status in breast cancer patients undergoing surgery. By examining this relationship, we seek to provide insights into how the integration of NPI and receptor status can refine prognostic models and inform clinical decision-making. |