| CTRI Number |
CTRI/2014/08/004920 [Registered on: 25/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Trial intended to study the role of sentinel node biopsy technique in women with breast cancer who have had prior surgery for a breast lump |
|
Scientific Title of Study
|
Validation of sentinel lymph node biopsy technique after prior lumpectomy in early breast cancer patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paul Augustine |
| Designation |
Additional Professor |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer Centre,
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447220035 |
| Fax |
91-471-2447454 |
| Email |
augustpaul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sridhar D |
| Designation |
Mch Surgical Oncology Resident |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer Centre,
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9567170760 |
| Fax |
|
| Email |
dasusridhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Paul Augustine |
| Designation |
Additional Professor |
| Affiliation |
Regional cancer centre |
| Address |
Regional cancer Centre,
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
R-1, Jainagar,
Medical College P.O.
Trivandrum – 695011.
Kerala, India.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9447220035 |
| Fax |
91-471-2447454 |
| Email |
augustpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional cancer center
Medical college PO
Trivandrum-695011
Kerala |
|
|
Primary Sponsor
|
| Name |
Regional Cancer Centre Trivandrum |
| Address |
Regional Cancer Centre
Medical College PO
Trivandrum -695011 |
| 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 |
| Paul Augustine |
Regional cancer center |
Department of surgical oncology
3rd floor
Medical College Campus PO, Thiruvananthapuram, Kerala 695011
0471 244 2541
Thiruvananthapuram
KERALA |
04712443290
augustpaul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human ethics committee, RCC Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Breast cancer patients-post lumpectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Literature data of sentinel lymph node biopsy technique in primary early breast cancer patients |
Comparison of efficacy of sentinel lymph node biopsy technique in post lumpectomy early breast cancer patients in terms of identification and false negative rates with literature data of lymph node biopsy technique in primary early breast cancer patients |
| Intervention |
Sentinel lymph node biopsy |
sentinel lymph node biopsy in post lumpectomy early breast cancer patients |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1)pT1,T2 tumours (based on the pathology report)
2)N0 breast cancers(clinically and radiologically)
3)Invasive breast adenocarcinoma
|
|
| ExclusionCriteria |
| Details |
1)Prior axillary surgery/Non oncologic breast surgery/ biopsies other than excision or lumpectomy/surgery to the ipsilateral breast prior to 3 months
2)Prior irradiation to the breast or axilla
3)Performance status ECOG 3,4
4)Pregnant and lactating women
5)Neoadjuvant Chemotherapy
6)Known Allergy to Human serum Albumin , Isosulfan Blue
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of
Identification rate
False negative rate |
To validate the efficacy of the sentinel node biopsy technique in post lumpectomy breast cancer patients in terms of
Identification rate
False negative rate |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine sensitivity ,specificity ,positive and negative predictive value of the technique by comparison to axillary dissection |
2 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a single institutional , single arm , interventional study being conducted to test the efficacy of the sentinel lymph node biopsy technique in post lumpectomy early breast cancer patients.The total number of patients will be 40 with the duration being 2 years.The primary end point of the study will be sentinel node identification rate and false negative rate.The results will be compared with similar studies conducted in the primary setting. Our ultimate aim is to use sentinel node biopsy technique as a staging tool for the axilla and eventually avoid the morbidity of axillary dissection in this group of patients. |