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Not yet recruiting NCT07690852

Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

— Observational Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

Overview

This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and/or diagnosed with early onset breast cancer.

Detailed description

PRIMARY OBJECTIVES:

I. To assess patient interest and emotional responses toward EERA and return of results.

II. To assess provider attitudes toward EERA integration into clinical workflows.

OUTLINE: This is an observational study. Participants are assigned to 1 of 3 aims.

AIM I: Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed.

AIM II: COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.

AIM III: Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Patient survey responses on perceived utility [Time frame: Up to one year]
  • Patient survey responses on willingness to engage [Time frame: Up to one year]
  • Patient survey responses on preferences for receiving EERA results [Time frame: Up to one year]
  • Provider survey responses on perceived utility [Time frame: Up to one year]
  • Provider survey responses on feasibility [Time frame: Up to one year]
  • Provider survey responses on preferences for EERA disclosures into workflows [Time frame: Up to one year]
  • Proportion of participants who wear the work wristband for a total of 1 week [Time frame: Up to one year]
  • Chemical exposure measured by Fresh Air Clip wristband [Time frame: Up to one year]

Eligibility criteria

Inclusion criteria

  • AIM 1 INCLUSION CRITERIA:
  • ONE of the following:
  • Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic/Likely Pathogenic \[P/LP\] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P/LP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)
  • Age: ≥ 18 years
  • Speak English or Spanish
  • Sex: female
  • Willingness to:
  • Participate in study activities
  • Permit medical record/ clinical laboratory result review
  • AIM 2 INCLUSION CRITERIA
  • Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)
  • Willingness to:
  • Participate in study activities
  • AIM 3 INCLUSION CRITERIA:
  • Provide written consent
  • ONE of the following:
  • Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P/LP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P/LP in breast cancer related genes) OR High Risk: gene carrier (defined by P/LP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)
  • Age: ≥ 18 years
  • Speak English or Spanish
  • Sex: female
  • Willingness to:
  • Wear the wristband for 1 week
  • Participate in study activities
  • Permit medical record/ clinical laboratory result review

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • City of Hope Medical Center — Duarte

Identifiers

NCT: NCT07690852 · 260159 · NCI-2026-04271 · 260159 · P30CA033572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗