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.
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.
Dr. Randa Hussein Abdelhady, Professor contact
About this study
Official title: Studying The Association Between Environmental Exposure to Polyfluoroalkyl Substances and Breast Cancer in Assiut Governorate- Egypt
- 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.
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 group | Role | What 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- 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.
- First posted13 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacklin Farouk Danial Beshay, Assiut University
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 32580117Itoh 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 34392213Pierozan 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 34843762Velarde 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying The Association Between Environmental Exposure to Polyfluoroalkyl Substances and Breast Cancer in Assiut Governorate- Egypt
- ClinicalTrials.gov ID
- NCT06457282
- Acronym / sponsor ID
- Breast Cancer andPFAS exposure
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case ( breast cancer patients) | – | – |
| Control ( Healthy people without breast cancer) | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- -
- Newly diagnosed cases. Who are diagnosed by ultrasonography and mammography and confirmed diagnosis after biopsy taken for histopathological examination.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 32580117Tsai 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.
- Background: PubMed 34392213Itoh 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.
- Background: PubMed 34843762Pierozan 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.
- Background: PubMed 34293563Velarde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Randa Hussein Abdelhady, Professor contact
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.