| CTRI Number |
CTRI/2024/04/066009 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of clinical outcome and recurrence pattern of triple negative breast cancer |
|
Scientific Title of Study
|
STUDY OF CLINICAL OUTCOME AND RECURRENCE PATTERN OF TRIPLE NEGATIVE BREAST CANCER IN NORTH INDIA. |
| 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 Mayank Tripathi |
| Designation |
Associate Professor |
| Affiliation |
Consultant |
| Address |
Breast DMG, 4th floor, Department of onco-surgery, Mahamana Pandit Madan Mohan Malaviya Cancer Hospital, Sundarpur, Varanasi
OPD-14, OPD Building, MPMMCC, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8059420490 |
| Fax |
|
| Email |
drmayanktripathi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dhaval Vadodaria |
| Designation |
M.ch Resident |
| Affiliation |
Senior Resident |
| Address |
Breast DMG, 4th floor, Department of onco-surgery, Mahamana Pandit Madan Mohan Malaviya Cancer Hospital, Sundarpur, Varanasi
OPD-14, OPD building, MPMMCC, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9428275789 |
| Fax |
|
| Email |
drdhavalvd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dhaval Vadodaria |
| Designation |
M.ch Resident |
| Affiliation |
Senior Resident |
| Address |
Breast DMG, 4th floor, Department of onco-surgery, Mahamana Pandit Madan Mohan Malaviya Cancer Hospital, Sundarpur, Varanasi
Opd-14, Opd Buildings, MPMMCC, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9428275789 |
| Fax |
|
| Email |
drdhavalvd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahamana Pandit Madan Mohan Malavia cancer Hospital, Sundarpur, Varanasi |
|
|
Primary Sponsor
|
| Name |
Nill |
| Address |
Nill |
| 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 Dhaval vadodaria |
Mahamana Pandit Madan Mohan Malviya Cancer Hospital |
Breast DMG, 4th floor, Department of onco-surgery, Mahamana Pandit Madan Mohan Malaviya Cancer Hospital, Sundarpur, Varanasi
Varanasi
UTTAR PRADESH |
9428275789
drdhavalvd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHAMANA PANDIT MADAN MOHAN MALAVNA CANCER CENTRE & HOMI BHABHA CANCER HOSPITAL INSTITUTIONALETHICS COMMITTEE (|EC) |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female patient
Age more than 18 years
Age less than 70 years
Biopsy and immunohistochemistry and IHC proved TNBC at MPMMCC Varanasi
Patient operated at MPMMCC Varanasi |
|
| ExclusionCriteria |
| Details |
Male patient
Age less than 18 years
Age more than 70 years
Other pathological subtypes of breast cancer
Non operated cases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. clinical outcome of TNBC patient.
2.access clinical response of TNBC patient after initiate of treatment
3.identify factors associated with early recurrence in TNBC patient.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the cliniopathological features of TNBC patient. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="83"
Sample Size from India="83"
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)
|
29/04/2024 |
| 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="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 (Others) - no
- What additional supporting information will be shared?
Response - Study Protocol
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 [drdhavalvd@gmail.com].
- For how long will this data be available start date provided 30-01-2024 and end date provided 30-05-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - no
|
|
Brief Summary
|
Breast cancer is the most common female cancer world�’wide. Molecular studies of breast carcinoma have classified the tumour based on the immunohistochemical staining into 4 subtypes, such as Luminal A, Luminal B, HER2/neu Positive and Triple Negative Breast Carcinoma (TNBC) Triple-negative breast cancer (TNBC), characterized by the lack of expression of estrogen receptor, progesterone receptor and human epidermal growth factor receptor-2, is typically associated with a poor prognosis. TNBCs are reported to have an aggressive behaviour and wide metastasis, leading to selective treatment outcomes. The aim was to know clinical outcome and recurrence pattern of triple negative breast cancer in patients from north india. Objectives of study are to know the clinical features of TNBC patient, to access clinical response of TNBC patient after initiate of treatment, to know recurrence pattern of TNBC and to identify factors associated with early recurrence in TNBC patient. The implication of study is that we can analyze the clinicopathological features of Triple Negative breast cancer and to compare it with reports from other regions of the world. It also provides prognostic significance of TN breast cancer. We can compare outcome and survival patterns of TNBC patient treated with various chemotherapy regimens and surgery. |