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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Time Frame
Start Date: 2026-12-28
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 423
Treatments
Observational 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.
Observational Aim II
COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.
Observational 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.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov