NCT06457282

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 13, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

June 8, 2024

Last Update Submit

June 8, 2024

Conditions

Outcome Measures

Primary Outcomes (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.

    2 yrs

Study Arms (2)

Case ( breast cancer patients)

Control ( Healthy people without breast cancer)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \. Patients who underwent neoadjuvant chemotherapy prior to their surgery will be excluded from the study.
  • 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.
  • Women with biopsy-proven benign breast disease should be excluded
  • Patients who have other malignancies are excluded
  • \. patients with family history of breast cancer will be excluded. 7. Patients refuse to continue the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 32580117BACKGROUND
  • 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.

    PMID: 34392213BACKGROUND
  • 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.

    PMID: 34843762BACKGROUND
  • 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.

    PMID: 34293563BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Dr. Randa Hussein Abdelhady, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

June 13, 2024

Record last verified: 2024-05