| CTRI Number |
CTRI/2024/11/076720 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prognostics Biomarker study in triple negative breast cancer patient
|
|
Scientific Title of Study
|
Vitamin D receptor (VDR), a prognostic biomarker in triple negative breast cancer patient: 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 |
Dr Jaishriram Rathored |
| Designation |
Associate Professor and Incharge CRL and Molecular Diagnostics |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Central Research Laboratory and Molecular Diagnostics
Research and Development Division
Research House
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319380593 |
| Fax |
|
| Email |
jaishriz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaishriram Rathored |
| Designation |
Associate Professor and Incharge CRL and Molecular Diagnostics |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Central Research Laboratory and Molecular Diagnostics
Research and Development Division
Research House
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319380593 |
| Fax |
|
| Email |
jaishriz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaishriram Rathored |
| Designation |
Associate Professor and Incharge CRL and Molecular Diagnostics |
| Affiliation |
Datta Meghe Institute of Higher Education and Research, Wardha |
| Address |
Department of Central Research Laboratory and Molecular Diagnostics
Research and Development Division
Research House
Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319380593 |
| Fax |
|
| Email |
jaishriz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Intramural Grant |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research Wardha |
| Address |
Department of Central Research Laboratory and Molecular Diagnostics
Research and Development Division
Research House
Datta Meghe Institute of Higher Education and Research
Wardha 442001
Maharashtra
India |
| 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 Jaishriram Rathored |
Acharya Vinoba Bhave Rural Hospital |
Central Research Laboratory CRL and Molecular Diagnostics R and D Unit Research House DMIHER Sawangi wardha Maharashtra India
Wardha
MAHARASHTRA |
8319380593
jaishriz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R978||Other abnormal tumor markers, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NIL |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants willing to give their written informed consent
2. Breast cancer patients who were admitted to AVBRH Hospital in Sawangi, Wardha, and who would visit the hospital for treatment or follow-up will be the Participants of this study.
3. Newly or old diagnosed Breast cancer (triple negative-ER, PR and Her2) or (triple positive-ER, PR and Her2) who received (at least six months prior to study registration) or who are receiving treatment (chemotherapy, radiation, and surgery) will be the study participant.
4. Female gender with age 18–65 years and whose body mass index (BMI) is in between 18 to 35 kg/m2 will be enrolled
5. Participants who did not get oral vitamin D3 supplements or intramuscular injections for a minimum of four months prior to study enrollment
6. Participants who agree to avoid from using food and herbal supplements while the intervention is conducted.
|
|
| ExclusionCriteria |
| Details |
1. Past medical records pertaining to malabsorption syndrome, disorders related to calcium metabolism, gastrointestinal, renal, inflammatory, and other endocrinological conditions that could potentially impede the study; receiving weight loss medication
2. Pregnancy and lactation
3. Participants with a known seizure disorder
4. Participants with known symptomatic cardiac disease, such as arrhythmias or coronary
artery diseases.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
Outcome will be measured by evaluating the low VDR mRNA expression levels compare with both the groups to define as a predictive biomarker to ascertain the prognosis of a TNBC patient
Secondary Outcomes:
Secondary Outcomes will be evaluated by analyzing vitamin D levels and may be used to define vitamin D deficiency risk and enable individualized primary cancer prevention and therapy for better prognosis of TNBC patients.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recent studies provide evidence on the prognostic significance of VDR in breast cancer, and their conclusions imply that VDR expression could be employed as a predictive biomarker to ascertain the prognosis of a patient with breast cancer |
2nd year |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="12"
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)
|
02/12/2024 |
| 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 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
|
Triple-negative breast cancer (TNBC) is an
aggressive subtype of breast cancer, accounting for 10–15% of all cases and
characterized by the absence of estrogen receptor (ER), progesterone receptor
(PR), and human epidermal growth factor receptor 2 (HER2). TNBC patients often
have a poor prognosis due to limited treatment options. Vitamin D receptor
(VDR) has been implicated in cancer prognosis, with previous studies suggesting
its potential role in modulating immune responses and tumor suppression. This
pilot study aims to investigate the association between VDR mRNA expression,
vitamin D levels, and their prognostic significance in TNBC patients. A
cross-sectional design will be used to compare 12 triple-Negative breast cancer
(TPBC) and 12 triple-positive breast cancer (TPBC) patients treated at AVBRH
Cancer Hospital, Wardha.
The primary hypothesis suggests that VDR pathway
activation and serum vitamin D levels could influence TNBC progression and
prognosis. Additionally, the study explores the potential for VDR to enhance
immune response and improve overall survival. By examining VDR mRNA expression
and vitamin D levels, the study seeks to assess vitamin D deficiency risk and
its implications for primary cancer prevention and treatment strategies.
Blood samples from participants will be analysed for
VDR mRNA expression and vitamin D levels. Statistical analysis will be
performed using SPSS, and results will be reported at a 95% confidence
interval. The expected outcome is that low VDR expression and vitamin D
deficiency will be associated with poor prognosis in TNBC patients, suggesting
that VDR may serve as a prognostic biomarker. This research could provide a
foundation for individualized treatment approaches based on vitamin D and VDR
status in TNBC patients. |