NCT05135013

Brief Summary

The aim of the current study is to investigate the association between hormonal intake, occupational and demographic factors, and the risk of breast cancer (BC) among Egyptian females.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

November 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

November 16, 2021

Last Update Submit

November 16, 2021

Conditions

Keywords

Hormonal Intake, Breast Cancer Risk, Demographic Factors

Outcome Measures

Primary Outcomes (1)

  • Confirmed Breast Cancer Patients

    Patients who were diagnosed with histopathologically confirmed breast cancer and were during the past 2 years to 2021 (2019-2020).

    During the past 2 years to 2021 (2019-2020).

Study Arms (2)

Cases

1.Cases (100) are those eligible patients who were diagnosed with histopathologically confirmed breast cancer and were during the past 2 years to 2021 (2019-2020).

Drug: Dydrogesterone Tablets, Norethisterone acetate, Ethinyl estradiol, Drospirenone and ethinyl estradiol

Matched Controls

2\. Matched controls (100) are those participants presenting to the screening clinic and were not diagnosed with breast cancer during the past 2 years to 2021 (2019-2020). Candidates are to be of same range of age (+/-3 years); and similar visiting period (+/-2 months). All controls were confirmed as having no diagnosis of breast cancer, with negative findings on physical breast examination, and breast sono-mammographic screening.

Drug: Dydrogesterone Tablets, Norethisterone acetate, Ethinyl estradiol, Drospirenone and ethinyl estradiol

Interventions

History of hormonal use as follows: 1. Reason for hormonal use: contraception, fertility promotion, Polycystic ovary syndrome (PCOS) 2. Duration of hormonal use 3. Type of hormonal drug used: dose, hormone type, route of administration

CasesMatched Controls

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible candidates will be stratified as cases or matched controls as follows: 1. Cases (100) are those eligible patients who were diagnosed with histopathologically confirmed breast cancer and were during the past 2 years to 2021 (2019-2020). 2. Matched controls (100) are those participants presenting to the screening clinic and were not diagnosed with breast cancer during the past 2 years to 2021 (2019-2020). Candidates are to be of same range of age (+/-3 years); and similar visiting period (+/-2 months). All controls were confirmed as having no diagnosis of breast cancer, with negative findings on physical breast examination, and breast sono-mammographic screening.

You may qualify if:

  • Age \> 18 and \< 70

You may not qualify if:

  • Diagnosed with other concurrent malignancies.
  • A prior history of another cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Norethindrone AcetateEthinyl Estradioldrospirenone

Intervention Hierarchy (Ancestors)

NorethindroneNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsNorpregnatrienesEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Nermeen Ashoush, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Clinical Pharmacy Practice Department

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 26, 2021

Study Start

November 16, 2021

Primary Completion

January 31, 2022

Study Completion

March 31, 2022

Last Updated

November 26, 2021

Record last verified: 2021-11