The Association of Hormonal Intake and Demographic Factors With Breast Cancer Risk. An Egyptian Case-controlled Study

November 16, 2021 updated by: Nermeen Ashoush, NewGiza University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Methodology Design. A case-controlled study.

Setting. Breast cancer clinic and breast cancer screening unit at clinical oncology department, Ain Shams University hospital

Participants.

All cases who will be screened from the BC clinic and the BC screening unit will be assessed for eligibility according to the following inclusion & exclusion criteria:

Inclusion criteria

Age > 18 and < 70

Exclusion criteria

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

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.

Ethical consideration. The protocol will be approved by the ethical committee of NGU and the Clinical Oncology department ASU. The study will be registered at clinicaltrials.gov

Methods.

Data collection for both groups will be done through reviewing of the participants' medical records retrospectively Data collection will include the following data:

  • Demographic data: name, age, sex, residence
  • Anthropometric data: height, weight, waist & hip circumference & waist to hip ratio and BMI calculation
  • Female & menopausal status, age at menarche
  • Medical history & comorbidity (CVS, DM 1 or 2, HTN)
  • Family history of other cancers, diabetes
  • Occupational history
  • Social history: smoking, recreational drug use, marital status, nulliparity/multi-parity and lactation
  • Dietary habits and diet composition
  • Lifestyle habits and degree of regular activity (sedentary, active, etc.)

  • History of hormonal use as follows:

    1. Reason for hormonal use: contraception, fertility promotion, PCOS
    2. Duration of hormonal use
    3. Type of hormonal drug used: dose, hormone type, route of administration

  • Breast cancer classification:

    1. - Type of pathology - 2- Molecular classification (ER, PR, Her2 receptors status) 3- Staging of BC.

Statistical analysis The frequency distribution of the parameters will be assessed. Parametric data will be presented as mean & standard deviation, while non parametric data will be presented as median & IQR. All data will be analyzed using the appropriate statistical test. Proportions will be presented using number & proportion and will be assessed by the Chi square.

Multiple logistic regression analysis will be used to calculate odds ratios (OR) and corresponding 95% confidence intervals (CI) for the various studied factors in relation to breast cancer occurrence & subtypes.

Moreover, the effect of the combined significant factors to the risk of breast cancer development will be evaluated.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • Age > 18 and < 70

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmed Breast Cancer Patients
Time Frame: During the past 2 years to 2021 (2019-2020).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NewGiza University

Collaborators

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 16, 2021

Primary Completion (ANTICIPATED)

January 31, 2022

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (ACTUAL)

November 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NewGiza University Protocol 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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