| CTRI Number |
CTRI/2024/06/068568 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Techniques to achieve complete tumor removal when performing breast conserving surgery for breast cancer |
|
Scientific Title of Study
|
Techniques of achieving tumor free margins in 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 |
Dr Priyal Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7905262134 |
| Fax |
|
| Email |
priyal.kmcmpl2023@learner.maipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Stanley Mathew |
| Designation |
Professor of General Surgery |
| Affiliation |
Kasturba Medical College and Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9844409900 |
| Fax |
|
| Email |
stanley.mathew@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Badareesh L |
| Designation |
Professor of General Surgery |
| Affiliation |
Kasturba Medical College and Kasturba Hospital, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba hospital, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8861038876 |
| Fax |
|
| Email |
badareesh.l@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, 3rd Floor, Smt.Sharadha Madhav Pai OPD Building, Kasturba Hospital, Kasturba Medical College, Manipal - 576104, Udupi District, Karnataka State, India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Dr.Padmaraj Hegde, Dean, First Floor, Administrative Building, Kasturba Medical College, Madhav Nagar, Manipal 576104, Udupi District, Karnataka State, India |
| Type of Sponsor |
Private 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 Stanley Mathew |
Kasturba Hospital, Manipal |
Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal - 576 104 Udupi KARNATAKA |
9844409900
stanley.mathew@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1) Female patients between 18 to 80 years
2) Biopsy proven carcinoma breast
3) Patient undergoing Breast Conservative Surgery either upfront or after receiving chemotherapy |
|
| ExclusionCriteria |
| Details |
1) Male breast carcinoma
2) Patients undergoing Modified Radical Mastectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of positive margins during the surgical procedure |
10 days - till final histopathological report is available |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of revision surgical procedures due to positive margin |
10 days - till final histopathological report is available |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
17/06/2024 |
| 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 - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response (Others) - Any regulatory agency or editor/reviewer of a scientific publication
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data will be provided based on a written request
- For how long will this data be available start date provided 31-08-2027 and end date provided 31-08-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
If Breast Conservation
Surgery has been planned for the patient, she will be approached to obtain written informed consent on the day of her
admission. Data associated with her pre operative evaluation will be collected
from the medical records. On the day of the operation, the surgeon will perform
the appropriate Breast Conservation Surgery. As part of the standard of care Wire Needle Localization, Specimen
Mammography, Specimen Ultrasound and Frozen section (with painting of margins) may be performed. These are
done to ensure that no tumour is remaining at the operated site. Data
associated with these standard of care procedures will also be collected for
this study. |