| CTRI Number |
CTRI/2024/06/069377 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How the androgen receptor, a protein, influences breast cancer treatment and impacts the patients future health.
|
|
Scientific Title of Study
|
Androgen receptor in breast cancer - clinical and prognostic outcomes |
| 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. Kotha S L KamakshiPasyanthi |
| Designation |
PG student |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Department of general surgery, kasturba Medical college, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8917539389 |
| Fax |
|
| Email |
kotha.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veena L Karanth |
| Designation |
Professor, Department of General Surgery |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Department of general surgery, Kasturba Medical college, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845417715 |
| Fax |
|
| Email |
veena.karanth@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sheena Wadhwa |
| Designation |
Senior resident |
| Affiliation |
Kasturba Medical college and Hospital |
| Address |
Department of general surgery, kasturba Medical college, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8709412993 |
| Fax |
|
| Email |
sheena.wadhwa@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General surgery, Kasturba Hospital, Manipal, udupi, karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Kotha S L Kamakshi Pasyanthi |
Kasturba Medical college and Hospital |
Department of general surgery ,3rd floor,New OPD block, Kasturba Hospital,manipal,Udupi District,
Udupi
KARNATAKA |
8917539389
kotha.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital Institutional Ethics Commitee -2 |
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 |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Patient undergoing surgery for breast cancer and specimen sent for IHC.
Patient who underwent trucut and sent for IHC.
All patients received treatment at KMC both for metastatic and non metastatic breast cancer.
Patients consenting to be part of study.
Patients above 18 years of age. |
|
| ExclusionCriteria |
| Details |
Age below 18 years.
Patient not willing to participate in study.
Male breast carcinoma.
Other malignancy at the time of breast cancer diagnosis.
Prior chemotherapy.
Patient failing tofollow up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of androgen receptor in breast cancer in our population.
The correlation of Androgen receptors with other biomarkers.
Prognosis and survival outcomes of the disease.
The patient outcomes will be seen at 3rd month and 6th month of follow up |
To asses the oncological outcomes, response to treatment.
The patient outcomes will be seen at 3rd month and 6th month of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the AR status with the staging of the breast cancer. |
To asses the response to treatment response to treatment at 3rd & 6th month |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
02/07/2024 |
| 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="1"
Months="6"
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
|
Patients with diagnosed breast cancer will be approached for participating in the study and will be explained the details of this study. Once patient agrees informed consent will be taken. The case will be recruited in the study and clinical history, examination, mammography report, tru cut IHC report will be collected. Post mastectomy specimen will be sent for immunohistochemistry staining, Generally we sent post mastectomy specimen for IHC staining of estrogen, progesterone receptors and HER2 neu receptors along with that androgen receptor staining will also be done. The incidence of expression of androgen receptors will find out , correlation of AR status with the staging of breast cancer and correlation of AR with other tumor markers we will find out.
|