| CTRI Number |
CTRI/2025/05/087008 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Surgical and Patient-Reported Outcomes After Breast-Conserving Surgery with Chest Wall Flap Reconstruction in Breast Cancer Patients |
|
Scientific Title of Study
|
A multi-centre PROspective study,
including PROMS of PARTial BREast ReCONstruction with chest wall
perforator flap |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr Amit Agrawal |
| Designation |
Consultant Oncoplastic Breast Surgeon |
| Affiliation |
Cambridge University Hospitals |
| Address |
Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom
CB2 0QQ
124105
Other |
| Phone |
|
| Fax |
|
| Email |
partbrecon.pros@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoutishman Saikia |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS New Delhi |
| Address |
Room no 14, Ground floor, Academic Building, NCI AIIMS,Jhajjar Haryana
Ansari Nagar
Jhajjar
HARYANA
124105
India |
| Phone |
9612892050 |
| Fax |
|
| Email |
jyoutishman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoutishman Saikia |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS New Delhi |
| Address |
Room no 14, Ground floor, Academic Building, NCI AIIMS,Jhajjar Haryana
Ansari Nagar
Jhajjar
HARYANA
124105
India |
| Phone |
9612892050 |
| Fax |
|
| Email |
jyoutishman@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi will support this studys infrastructural funding. |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Australia
France
Germany
Italy
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoutishman Saikia |
AIIMS New Delhi |
Room no 14, Ground Floor, Academic Building, NCI AIIMS Jhajjar Campus, AIIMS New Delhi Ansari Nagar
South
DELHI |
9612892050
jyoutishman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
No comparator agent as this is an observational study. |
| Intervention |
NIL |
No intervention agents as this is an observational study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients undergoing partial breast reconstruction using CWPF for primary breast cancer
2. Delayed correction of breast deformity following previous BCS
3. Each surgeon is to have performed a minimum of 10 CWPFs
4. Each centre anticipates completing a minimum of 10/year |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing volume displacement BCS
2. Patients undergoing mastectomy +/- immediate breast reconstruction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A) Patient Demographics and Tumour characteristics
1. Patient demographics: age, body mass index (BMI), comorbidities
2. Preoperative tumour characteristics and location influencing surgical planning
B) Treatment characteristics
1. Surgical: operative data, including flap types and distribution
2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
C) Primary outcome: Surgical
1. Complications
2. Oncological clearance: Re-excision rates, conversion to mastectomy
D) Secondary outcomes
1. Revisional surgery
2. Surveillance
3. Oncological: Recurrence and Mortality
E) Patient-reported outcomes
1. Pre-operative
2. Post-operative (pre-radiotherapy)
3. Post-radiotherapy (6 months) |
A) Patient Demographics and Tumour characteristics
1. Patient demographics: age, body mass index (BMI), comorbidities
2. Preoperative tumour characteristics and location influencing surgical planning
B) Treatment characteristics
1. Surgical: operative data, including flap types and distribution
2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
C) Primary outcome: Surgical
1. Complications
2. Oncological clearance: Re-excision rates, conversion to mastectomy
D) Secondary outcomes
1. Revisional surgery
2. Surveillance
3. Oncological: Recurrence and Mortality
E) Patient-reported outcomes
1. Pre-operative
2. Post-operative (pre-radiotherapy)
3. Post-radiotherapy (6 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Revisional surgery
2. Surveillance
3. Oncological: Recurrence and Mortality |
30 days after surgery
3 monthly after treatment completion for the first two years, 6 monthly for the next 3 years, Yearly thereafter (after 5th year) |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="30"
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)
|
30/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Summary of PartBreCon-Pro Study ProtocolStudy Type: Multicentre prospective cohort study on partial breast reconstruction using chest wall perforator flaps (CWPF). Objective: Evaluate clinical and patient-reported outcomes post-breast-conserving surgery. Duration: 36 months (June 2023 - May 2026). Data Collection: Includes surgical outcomes, oncological treatment, and patient-reported outcomes (PROMs). Significance: Aims to establish performance standards and improve patient care in breast cancer treatment. Contact: partbrecon.pros@gmail.com
|