Studying The Association Between Environmental Exposure to PFAS and Breast Cancer in Assiut Governorate- Egypt

June 8, 2024 updated by: Jacklin Farouk Danial Beshay, Assiut University

Studying The Association Between Environmental Exposure to Polyfluoroalkyl Substances and Breast Cancer in Assiut Governorate- Egypt

  1. Measuring serum level of PFAS in breast cancer female patients and healthy participants.
  2. Studying the correlation between serum level of PFAS and breast cancer risk through statistical modeling and analysis.
  3. Studying the magnitude of environmental exposure through measuring levels of PFAS in air and water sources of corresponding participants.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

  • Perfluoroalkyl substances (PFASs) are persistent pollutants that are present in the environment.
  • Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), known as the most detected per- and polyfluoroalkyl substances (PFAS)in various environmental compartments.They have been associated with plastic pollution and endocrine dysfunction.

Humans are exposed to PFASs through various pathways, including dietary items such as seafood, drinking water, and some dental floss.. Contaminated drinking water and food supply are potential sources of 0ral exposure to PFAS PFASs have been used in various products such as firefighting foams, surfactants, non-stick pans, food contact materials such as boxes, bags, wrappers, cups, (Lim, 2019), and table wares, and personal care products including cosmetics.

Over the past 180 years (1839-2019), numerous emerging contaminants have been identified, Perfluorooctanoic acid (PFOA) and perfluoro octane sulfonate (PFOS) are two of the most used PFAS compounds in various applications and have already been identified as endocrine-disrupting chemicals(EDCs).

Due to their structural and functional similarities with endogenous steroid hormones, EDCs mimic and interfere with homeostatic mechanisms and signaling pathways of hormones in the body even at low concentrations. They cause a variety of endocrine and metabolic disorders ,developmental abnormalities and hormone-dependent cancers.

PFAS exhibits a wide range of toxic effects, including developmental toxicity, genotoxicity, carcinogenicity, hepatotoxicity, reproductive toxicity, immunotoxicity, cytotoxicity, neurotoxicity, and hormonal toxicity.

Moreover, the International Agency for Research on Cancer (IARC) has classified PFOA as "possibly carcinogenic to humans".

Breast cancer is one of the major female health problems worldwide. Although there is growing evidence indicating that pollution increases the risk of breast cancer, there is still inconsistency among previous studies.

As we mentioned before, that PFAS is considered as EDC.so it may interact with estrogen receptors (ATSDR, 2018). And multiple studies found association between PFOS exposure and decreasd serum or saliva concentrations of estrogen in women.

It is well known that breast cancer is hormone-dependent, its development may be associated with exposure to xenoestrogens found in environmental pollutants (Adami et al., 2018).

Multiple epidemiological (Morgan et al., 2017) and experimental studies (Pierozan et al., 2018; Pierozan and Karlsson, 2018;) have associated EDC exposure with increased risk of breast cancer and breast cancer metastasis.Exposure to some PFASs has been both positively (Mancini et al., 2020; Tsai et al., 2020) associated with breast cancer risk as in Greenlandic Inuit women.and inversely associated with breast cancer risk as inTaiwanese women.

The presented study will be the first study to be done in Egypt to study the risk of PFAS environmental exposure and its correlation to breast cancer. Currently, there is no information available on the production, use, management and bio persistence of PFAS substances in Egypt. This is an area that needs attention, particularly for substances dispersed directly into the environment such as PFAS. And performing a risk assessment study identifying high exposure levels to various PFAS compounds in Assiut Governorate which will help in establishing the PFAS Egyptian toxicological report recommended by the Ministry of Environment as a part of the Stockholm Convention to protect human health and the environment from persistent organic pollutants.With increasing concerns of climate changes and global warming Egypt proceeded in setting recommendations for PFAS elimination.These recommendation contributes to the achievement of several key Sustainable Development Goals (SDGs) due to the impacts of the substances on health and ecosystems including water pollution.

Study Type

Observational

Enrollment (Estimated)

42

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

Study Contact Backup

  • Name: Dr. Randa Hussein Abdelhady, Professor
  • Phone Number: 01006723004

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Female women age group between 18: 65 years. 2. Newly diagnosed cases. Who are diagnosed by ultrasonography and mammography and confirmed diagnosis after biopsy taken for histopathological examination

Description

Inclusion Criteria:

-

Newly diagnosed cases. Who are diagnosed by ultrasonography and mammography and confirmed diagnosis after biopsy taken for histopathological examination.

Exclusion Criteria:

  • 1. Patients who underwent neoadjuvant chemotherapy prior to their surgery will be excluded from the study.

    2.To eliminate confounding factors, breast cancer patients with comorbidities and chronic diseases such as uncontrolled diabetes mellitus or other endocrine disorders, poorly controlled hypertension, acute coronary syndrome, congestive heart failure, chronic kidney disease and chronic liver disease will be excluded.

    3.Women with biopsy-proven benign breast disease should be excluded

    .4. Patients who have other malignancies are excluded

    6. patients with family history of breast cancer will be excluded. 7. Patients refuse to continue the study

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
Case ( breast cancer patients)
Control ( Healthy people without breast cancer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1- Measuring serum level of PFAS in breast cancer female patients and healthy participants.
Time Frame: 2 yrs

Studying the correlation between serum level of PFAS and breast cancer risk through statistical modeling and analysis.

Studying the magnitude of environmental exposure through measuring levels of PFAS in air and water sources of corresponding participants.
2 yrs

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

June 8, 2024

First Submitted That Met QC Criteria

June 8, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast Cancer andPFAS exposure

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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