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Prognostics Biomarker study in triple negative breast cancer patient

Vitamin D receptor (VDR), a prognostic biomarker in triple negative breast cancer patient: Pilot Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076720
Enrollment
24
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R978- Other abnormal tumor markers

Interventions

Intervention1: Nil: NIL Control Intervention1: Nil: Nil

Sponsors

Datta Meghe Institute of Higher Education and Research Wardha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 1 year

Secondary

MeasureTime frame
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 cancerTimepoint: 2nd year

Countries

India

Contacts

Public ContactDr Jaishriram Rathored

Datta Meghe Institute of Higher Education and Research, Wardha

jaishriz@gmail.com8319380593

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026