| CTRI Number |
CTRI/2024/09/073710 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study investigating a surgical technique called Targeted Axillary Dissection (TAD) in patients with breast cancer who had received chemotherapy |
|
Scientific Title of Study
|
Targeted Axillary Dissection (TAD) with radiological guidance in post-chemotherapy breast cancer patients: A pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedita Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology
OPD 5th Floor, A-Block, AIIMS Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
7034635141 |
| Fax |
|
| Email |
nivsha1985@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nivedita Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology
OPD 5th Floor, A-Block, AIIMS Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
7034635141 |
| Fax |
|
| Email |
nivsha1985@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nivedita Sharma |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Jodhpur |
| Address |
Department of Surgical Oncology
OPD 5th Floor, A-Block, AIIMS Jodhpur
Jodhpur RAJASTHAN 342005 India |
| Phone |
7034635141 |
| Fax |
|
| Email |
nivsha1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Marudhar Industrial Area, 2nd Phase, MIA 1st phase, Basni, Jodhpur, Rajasthan, India. PIN-342003 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Marudhar Industrial area, 2nd phase, MIA, 1st phase Basni, Jodhpur, PIN-342005 |
| 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 Nivedita Sharma |
All India Institute of Medical Sciences, Jodhpur |
Room No 509, Block A, Department of Surgical Oncology, OPD Block, AIIMS Jodhpur, Marudhar Industrial Area, 1st phase Basni, Jodhpur 342005 Jodhpur RAJASTHAN |
7034635141
nivsha1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Targeted Axillary Dissection |
Targeted Axillary dissection guided by pre-NACT axillary node clipping and peri-operative radiological guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
• Patients with cT1-3 N1 M0 carcinoma breast irrespective of histology or hormonal receptor status scheduled to receive neoadjuvant chemotherapy (NACT)
• Patients with FNAC or biopsy proven positive axillary lymph node
|
|
| ExclusionCriteria |
| Details |
• Patients with previous ipsilateral axillary surgery
• Patients with previous radiotherapy to ipsilateral axilla
• Patients allergic to methylene blue dye or fluorescein dye
• Patients who have palpable axillary lymph nodes on clinical examination post-NACT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the identification rate of TAD with ultrasound guidance in post-NACT carcinoma breast patients |
Intra-operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine Technical Failure Rate (TFR) of clipped node biopsy – percentage of patient in which clipped node could not be identified and removed. |
Intra-operative |
| To determine False Negative rate (FNR) of TAD with ultrasound guidance in post-NACT carcinoma breast patients |
Perioperative |
| To the evaluate the concordance between clipped lymph node (CLN) and sentinel lymph node (SLN) |
Intra-operative |
|
|
Target Sample Size
|
Total Sample Size="30" 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)
|
01/10/2024 |
| 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 - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nivsha1985@gmail.com].
- For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In breast cancer patients, the optimal surgical management of the axilla has been controversial especially in node positive patients. Until recently, axillary lymph node dissection (ALND) was considered standard in such patients. ALND not only provided accurate staging by assessing pathological lymph node status but also ensured locoregional control as well as helped guiding systemic therapy. Nevertheless, it is associated with higher morbidity in terms of lymphedema, shoulder syndrome, recurrent seromas, sensory loss in arm etc. This gradually led to identification of sentinel lymph node biopsy (SLNB) as a feasible alternative with much lesser morbidity. Though SLNB is now considered standard of care in node negative early breast cancer, its role in initially node positive patients who achieve complete clinical axillary response with neoadjuvant chemotherapy (NACT) is still evolving. Initial trials on SLNB in node positive breast cancer patients receiving NACT had high FNR of 13-15%. Attempts to decrease the FNR further, led to evolution of Targeted Axillary Dissection (TAD) which involves marking of suspected lymph node prechemotherapy and then localizing and removing that node along with other sentinel lymph nodes. Various methods of marking and localising the suspected nodes have been reported in literature, but there is lack of consensus on the most appropriate or feasible technique. While few techniques like radioactive seed localisation has good identification rate, difficulty in procurement, strict regulatory guidelines of use and high cost on radioactive isotopes has prevented its widespread adoption. Also, there is lack of data on targeted axillary dissection from Indian subcontinent. Through this study, we aim to assess feasibility and performance of targeted axillary dissection utilizing pre-operative and intra-operative ultrasound guidance in node positive breast cancer patients who achieve complete axillary response after NACT. Once the feasibility and accuracy of this technique is established, it will provide a cost-effective option of performing TAD in growing economies as well as resource constraint settings. Also, this study will further guide as to design prospective trial to study long term oncological outcomes of TAD and SLNB in this subset of patients.
Research Hypothesis Clipping the positive lymph node pre-NACT and ensuring removal of that node along with other sentinel lymph nodes during SLNB using preoperative/ intraoperative ultrasound should decrease the FNR of SLNB in post-NACT carcinoma breast patients.
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