NCT03594214

Brief Summary

In our study; we aim to analyze the correlation between pre-treatment serum vitamin D (VD) levels and breast cancer prognostic features in newly diagnosed breast cancer patients presenting to our department.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

July 2, 2018

Last Update Submit

February 6, 2021

Conditions

Vitamin D Deficiency

Keywords

breast cancervitamin dprognosis

Outcome Measures

Primary Outcomes (1)

  • Correlation of vitamin D levels with prognostic features

    Analysis of the correlation between; pre-treatment serum vitamin D levels, and breast cancer prognostic features.

    2 years

Secondary Outcomes (1)

  • Correlation of vitamin d levels with treatment outcomes

    5 years

Study Arms (1)

Single arm

pre-treatment serum vitamin d level measured by ELISA kit in patients confirmed for diagnosis with invasive breast cancer and before receiving any treatment for breast cancer

Diagnostic Test: serum vitamin d level measured by ELISA kit

Interventions

serum vitamin d level measured by ELISA kitDIAGNOSTIC_TEST

serum vitamin d level will be measured by a blood sample from newly diagnosed breast cancer patients just after diagnosis (either by surgery specimen or FNA or excisional biopsy specimen) and before receiving any type of treatment for breast cancer

Single arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with newly diagnosed invasive breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients newly diagnosed with non-metastatic breast cancer, treatment-naive presenting to clinical oncology department at Assiut University Hospitals

You may qualify if:

  • Female patients
  • Newly diagnosed breast cancer patients.
  • Histologically confirmed invasive breast carcinoma (IBC)
  • Non- metastatic.
  • Treatment naïve patients.
  • Age: ≥18 and older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Patients must have normal organ function as regards LFTs and RFTs

You may not qualify if:

  • Male patients
  • Metastatic patients
  • Previous history of breast cancer diagnosis or treatment
  • Kidney impairment or renal stones
  • History of parathyroidectomy
  • Hypercalcemia, defined as serum level \>11 mg/dl.
  • Abnormal laboratory data for: AST (SGOT), ALT (SGPT), Serum Bilirubin, Alkaline phosphatase, Creatinine and/or Creatinine clearance, and Albumin.
  • Female patients who are pregnant or breast feeding.
  • Patients already on treatment or previously treated for vitamin D defeciency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (2)

  • de Sousa Almeida-Filho B, De Luca Vespoli H, Pessoa EC, Machado M, Nahas-Neto J, Nahas EAP. Vitamin D deficiency is associated with poor breast cancer prognostic features in postmenopausal women. J Steroid Biochem Mol Biol. 2017 Nov;174:284-289. doi: 10.1016/j.jsbmb.2017.10.009. Epub 2017 Oct 12.

    PMID: 29031688BACKGROUND

  • Ismail A, El-Awady R, Mohamed G, Hussein M, Ramadan SS. Prognostic Significance of Serum Vitamin D Levels in Egyptian Females with Breast Cancer. Asian Pac J Cancer Prev. 2018 Feb 26;19(2):571-576. doi: 10.22034/APJCP.2018.19.2.571.

    PMID: 29481024BACKGROUND

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Neoplasms

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dina B Saber, Ass.Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Samir Sh Eid, professor

    Assiut University

    STUDY DIRECTOR

  • Abeer F Amin, A.professor

    Assiut University

    STUDY DIRECTOR

  • Maha S El-Naggar, lecturer

    Assiut University

    STUDY DIRECTOR

  • Dalia T Kamal, lecturer

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 2, 2018

First Posted

July 20, 2018

Study Start

September 1, 2018

Primary Completion

August 31, 2021

Study Completion

September 1, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)