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Breast CancerNCT06457282

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

An observational study of Breast Cancer, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
How many people
42 participants
Where
No sites listed yet
Study dates
Jul 2024to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Jacklin Farouk contact

01207507866

gigifarouk22@gmail.com

Dr. Randa Hussein Abdelhady, Professor contact

01006723004

About this study

Official title: 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.
Read the 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.

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06457282
Study groupRoleWhat they receive
Case ( breast cancer patients)Not described
Control ( Healthy people without breast cancer)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1- Measuring serum level of PFAS in breast cancer female patients and healthy participants.

    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.

    Measured: 2 yrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06457282
Sponsor's protocol ID
Breast Cancer andPFAS exposure
Status last verified
May 2024
First submitted
8 Jun 2024
Last updated
13 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tsai MS, Chang SH, Kuo WH, Kuo CH, Li SY, Wang MY, Chang DY, Lu YS, Huang CS, Cheng AL, Lin CH, Chen PC. A case-control study of perfluoroalkyl substances and the risk of breast cancer in Taiwanese women. Environ Int. 2020 Sep;142:105850. doi: 10.1016/j.envint.2020.105850. Epub 2020 Jun 21.

    PubMed 32580117
  • Itoh H, Harada KH, Kasuga Y, Yokoyama S, Onuma H, Nishimura H, Kusama R, Yokoyama K, Zhu J, Harada Sassa M, Tsugane S, Iwasaki M. Serum perfluoroalkyl substances and breast cancer risk in Japanese women: A case-control study. Sci Total Environ. 2021 Dec 15;800:149316. doi: 10.1016/j.scitotenv.2021.149316. Epub 2021 Jul 29.

    PubMed 34392213
  • Pierozan P, Cattani D, Karlsson O. Tumorigenic activity of alternative per- and polyfluoroalkyl substances (PFAS): Mechanistic in vitro studies. Sci Total Environ. 2022 Feb 20;808:151945. doi: 10.1016/j.scitotenv.2021.151945. Epub 2021 Nov 27.

    PubMed 34843762
  • Velarde MC, Chan AFO, Sajo MEJV, Zakharevich I, Melamed J, Uy GLB, Teves JMY, Corachea AJM, Valparaiso AP, Macalindong SS, Cabaluna ND, Dofitas RB, Giudice LC, Gerona RR. Elevated levels of perfluoroalkyl substances in breast cancer patients within the Greater Manila Area. Chemosphere. 2022 Jan;286(Pt 1):131545. doi: 10.1016/j.chemosphere.2021.131545. Epub 2021 Jul 12.

    PubMed 34293563

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jacklin Farouk (01207507866, gigifarouk22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1- Measuring serum level of PFAS in breast cancer female patients and healthy participants. (time frame: 2 yrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06457282, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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