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Набор скоро начнётся NCT07690852

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

— Наблюдательное Breast Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Non-Interventional Study.
Кому может быть актуально
Состояния в реестре: Breast Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Non-Interventional Study
    Non-interventional study

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 1 центр
  • City of Hope Medical Center — Duarte

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗