| CTRI Number |
CTRI/2024/06/069276 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Gross examination of the specimen after Breast conservative surgery in predicting margin negativity |
|
Scientific Title of Study
|
Diagnostic accuracy of surgical margin obtained through gross examination of the specimen in predicting margin negativity among patients undergoing Breast conservative surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivareddy |
| Designation |
Junior Resident, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Surgery office, 2nd floor, institute block, JIPMER, PUDUCHERRY
PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7899964024 |
| Fax |
|
| Email |
reddy08787@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreenath GS |
| Designation |
Additional professor, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Surgery office, 2nd floor, Institute Block, JIPMER, Dhanavantri Nagar PUDUCHERRY
PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486690883 |
| Fax |
|
| Email |
dr.sreenathgs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivareddy |
| Designation |
Junior Resident, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Surgery office, 2nd floor, Institute block, JIPMER, Dhanavantri nagar, PUDUCHERRY
PUDUCHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7899964024 |
| Fax |
|
| Email |
reddy08787@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research, Puducherry, INDIA-605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER PUDUCHERRY |
| Address |
Jawaharlal institute of postgraduate medical education and research, Puducherry, INDIA-605006 |
| 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 Shivareddy |
Jawaharlal institute of postgraduate medical education and research, Puducherry, INDIA-605006 |
Surgery office, 2nd floor, institute block, Jawaharlal institute of postgraduate medical education and research, Puducherry, INDIA-605006
Pondicherry
PONDICHERRY |
7899964024
reddy08787@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1. Women of age more than 18 years
2.Tumor stage T1, T2, T3, N0, N1 according to AJCC
with no distant metastasis
3. Single clinical and mammographic lesion
4. Patients with residual disease following NACT and
planned for BCS |
|
| ExclusionCriteria |
| Details |
1. Tumor stage T4, N2 OR M1 according to the AJCC 8th edition
2. Presence of multifocal and multicentric lesion
3. Patients with complete clinical/radiological response to chemotherapy
4. Tumor to breast tissue ratio is very high
5. Recurrent breast carcinoma
6. Women with a strong family history of carcinoma of breast or BRCA1 and BRCA2 mutation carriers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the diagnostic utility of surgical margin obtained through
gross examination in predicting margin negativity in patients
undergoing breast conservative surgery- Margin of BCS specimen will be assessed intra-op |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Re-excision rate
2. Margin negativity at re-excision |
Base line |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
17/07/2024 |
| 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="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
|
Diagnostic accuracy of surgical margin obtained through intraoperative gross examination of the specimen in predicting margin negativity among patients undergoing Breast conservative surgery, A observational study- single institute study with primary outcome being To assess the diagnostic utility of surgical margin obtained through gross examination in predicting margin negativity in patients undergoing breast conservative surgery, with 56 as total sample size and participants have been recruited |