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

Sponsor

NewGiza University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05135013

Collaborator

Ain Shams University (Other)

200

Enrollment

4.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Observational Study	Drug: Dydrogesterone Tablets, Norethisterone acetate, Ethinyl estradiol, Drospirenone and ethinyl estradiol

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:

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).
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:

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

Breast cancer classification:

- 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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Nov 16, 2021

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	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: Reason for hormonal use: contraception, fertility promotion, Polycystic ovary syndrome (PCOS) Duration of hormonal use 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: Reason for hormonal use: contraception, fertility promotion, Polycystic ovary syndrome (PCOS) Duration of hormonal use Type of hormonal drug used: dose, hormone type, route of administration

Arm

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: Reason for hormonal use: contraception, fertility promotion, Polycystic ovary syndrome (PCOS) Duration of hormonal use 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

Outcome Measures

Primary Outcome Measures

Confirmed Breast Cancer Patients [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).