Recruiting
Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
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.
ClinicalTrials.gov IDNCT07690852
PhaseNot Applicable
Enrollment423
SponsorCity of Hope Medical Center
Age18 Years
SexFEMALE
Conditions studied
Breast Carcinoma
About this study
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.
Interventions
- Other: Non-Interventional Study — Non-interventional study
Primary outcomes
- Patient survey responses on perceived utility (Up to one year)
- Patient survey responses on willingness to engage (Up to one year)
- Patient survey responses on preferences for receiving EERA results (Up to one year)
- Provider survey responses on perceived utility (Up to one year)
- Provider survey responses on feasibility (Up to one year)
- Provider survey responses on preferences for EERA disclosures into workflows (Up to one year)
- Proportion of participants who wear the work wristband for a total of 1 week (Up to one year)
- Chemical exposure measured by Fresh Air Clip wristband (Up to one year)
Eligibility information
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
Study locations
- City of Hope Medical Center, Duarte, California 91010 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.