| CTRI Number |
CTRI/2024/05/066667 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Observation of surgical related Cosmesis and Cosmesis related outcome reported by patients after patient’s breast conservation surgery and reconstruction |
|
Scientific Title of Study
|
Surgical Cosmesis And patient reported outcome measures in patients who have undergone tRansposition flap reconstruction after BCS (SCAR)
|
| Trial Acronym |
SCAR Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol Version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalaka P Joshi |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Hosiptal |
| Address |
Room No 1208 Homi Bhabha Building Tata Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zeal Sanghvi |
| Designation |
Research Fellow |
| Affiliation |
Tata Memorial Hosiptal |
| Address |
Room No 104
Homi Bhabha Building Tata Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224176112 |
| Fax |
|
| Email |
zealsanghvi93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalaka P Joshi |
| Designation |
Professor and Surgeon |
| Affiliation |
Tata Memorial Hosiptal |
| Address |
Room No 1208 Homi Bhabha Building Tata Memorial Hospital Parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177198 |
| Fax |
|
| Email |
drjoshishalaka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital Dr Ernest Borges Road Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shalaka Joshi |
Tata Memorial Hospital |
Room no 103,Homi bhabha building
breast unit Dr E borges road parel mumbai
Mumbai
MAHARASHTRA |
02224177000
drjoshishalaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tata Memorial Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NIl |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.All patients who have undergone a breast conservative surgery (from Jun 2014 to June 2023) with a Transposition Flap
2.All patients willing for the study
|
|
| ExclusionCriteria |
| Details |
1.All patients undergoing procedures other than Transposition Flap.
2.All metastatic patients.
3.Patients not willing to give consent.
4.Pregnant women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient reported outcome measure obtained by the BREAST-Q BCS module.
|
the patients will be administered the BREAST-Q BCS module at Baseline visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Clinical outcome parameters such as margin positive rate, local recurrence and disease-free survival.
2.Subjective cosmetic assessment by Modified Harvard Scale5
3.Objective cosmetic assessment by BCCT.Core software
|
at baseline visit |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
10/05/2024 |
| 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 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 - NO
|
|
Brief Summary
|
1. Aim To analyse the Surgical Cosmesis And patient reported outcome measures in patients who have undergone tRansposition flap reconstruction after BCS . 2. Objectives Primary Objective: 1. Patient reported outcome measure obtained by the
BREAST-Q BCS module Secondary Objectives: 1. Clinical outcome parameters such as margin positive rate, local recurrence and disease-free survival. 2. Subjective cosmetic assessment by Modified Harvard Scale5 3. Objective cosmetic assessment by BCCT.Core software 4. Surgical morbidity rate Materials And Methods Patients operated from Jun 2014 till Jun 2023 with transposition flap surgery with BCS will be screened during their routine follow-up visits, starting at first follow up- which is 6 months post radiation. They will be then administered the Informed Consent Form and the study will be explained in detail to them. After willing to voluntarily participate in the study and signing the ICF, the patients will be administered the BREAST-Q BCS module (Baseline Visit). Patients’ clinical photographs will be taken to assess the cosmesis objectively using the BCCT.core software. Subjective assessment will be done independently by breast oncoplastic or plastic surgeon and clinical photographs will be taken at the same time. As per routine, mammogram will be done during the follow up. The BREAST-Q BCS questionnaire has been recently translated by us in Hindi and Marathi and validation from the MAPI Trust is in the process. [The translated and the original English versions are attached here as annexure (2)]. This will be a single timepoint cross sectional analysis of outcomes. Clinico-pathological data is prospectively maintained and further information will be collected from electronic medical records (EMR) to analyse oncological outcomes like margin positivity, cancer recurrence, locally or distally. Any history of surgical morbidity- clinical or radiological- will be recorded- For e.g. Fat necrosis, wound infection, flap necrosis, etc. |