| CTRI Number |
CTRI/2024/04/064982 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Pre clinical |
| Study Design |
Other |
|
Public Title of Study
|
To study about DSC3 protein presence in triple negative hormone status in breast cancer patients. |
|
Scientific Title of Study
|
Evaluation of DSC-3 expression in triple negative breast cancer (TNBC) |
| 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 Sudeep Gupta |
| Designation |
Director TMC and Professor Medical Oncology |
| Affiliation |
|
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Director TMC and Professor Medical Oncology |
| Affiliation |
|
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudeep Gupta |
| Designation |
Director TMC and Professor Medical Oncology |
| Affiliation |
|
| Address |
Room no: 1109, 11 floor,
Homi Bhabha Building
Tata Memorial Hospital
E Borges Marg
Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177201 |
| Fax |
02224177201 |
| Email |
sudeepgupta04@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre
E Borges Marg.
Parel.
Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
TATA MEMORIAL HOSPITAL
Dr. E Borges Road,
Parel, Mumbai - 400 012 |
| Type of Sponsor |
Other [Goverment organization] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Artemis Health Research Foundation |
Artemis Institute, Sector 51, Gurugram - 122001, Haryana, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudeep Gupta |
Tata Memorial Centre |
Room no: 106/107
1st floor,
Homi Bhabha Building
Tata Memorial Hospital
Mumbai
MAHARASHTRA |
02224177201
02224177201
sudeepgupta04@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre |
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 |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Histopathological diagnosis of TNBC.
2.Patients who have undergone curative surgery (BCT or MRM) for breast cancer either after initial treatment or after neoadjuvant chemotherapy.
3.Either disease free survival from the time of diagnosis of atleast 2 years and no relapse OR relapse after initial curative treatment at any timepoint.
4.Initial clinical stage 1 to 3 disease.
5.Availability of the paraffin blocks of fulfilling the above criteria.
|
|
| ExclusionCriteria |
| Details |
1.Non availability of tumor tissue block.
2.No available survival data.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the immunohistochemical expression of DSC3 in tumor blocks of patients with triple negative breast cancer and determine the cutoff levels of its expression for segregating patients with and without relapse in the discovery cohort |
12 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
19/02/2025 |
| 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 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
|
In
this study we will assemble a discovery cohort of blocks from patients with
TNBC who have or have not experienced relapse with a defined followup time.
A
total of stage 1-3 TNBC patients will be selected, 35 with no relapse with
atleast 2 years of follow and 15 patients with relapse at any time point after
initial curative treatment. |