Recruiting

Observational Study

Sponsor:

City of Hope Medical Center

Code:

NCT07690852

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Interventional Study

Study Details

Brief 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.

Conditions

Breast Carcinoma

Study ID

NCT07690852

Start date

Dec 28, 2026

Status verified date

Aug, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

423 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Stacy W. Gray

626-218-4768stagray@coh.org

Principal Investigator:

Stacy W. Gray

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-31.