Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
Recruiting · NCT07690852 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Non-Interventional Study
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- City of Hope Medical Center - Duarte, California, United States