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Идёт набор NCT07038785

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

— Наблюдательное Breast Cancer

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: Breath test.
Кому может быть актуально
Состояния в реестре: Breast Cancer. 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, Израиль
Следующий шаг
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Официальное название

A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)

Обзор

The goal of this study is to find out whether a system that uses trained detection dogs and artificial intelligence (AI) can identify breast cancer from a person's breath. Women who are scheduled to have routine breast cancer screening, such as a mammogram, ultrasound, or a biopsy for a possible cancer, will be invited to take part. Participants will be asked to breathe into a surgical mask to collect a breath sample. The mask will be sent to a special laboratory, where trained dogs and an AI-based system will check the sample for signs of breast cancer. The results from the dogs and AI will be compared to the actual results from the medical screening or biopsy to see how accurate the system is at detecting breast cancer.

Вмешательства

  • Диагностический тест Breath test
    Breath sample collection using a sample collection kit

Первичные конечные точки

  • Test Performance Evaluation [Срок оценки: 24 months]
Вторичные конечные точки (4)
  • Test Performance Evaluation in different subgroups [Срок оценки: 24 months]
  • Test Performance in early-stage cancer [Срок оценки: 24 months]
  • Test Performance in the clinic vs. at patients' home [Срок оценки: 24 months]
  • Effect of psychological impacts on performance in the enriched arm [Срок оценки: 12 months]

Критерии участия

INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)

  • Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Assigned female at birth.
  • 40 years of age and above OR
  • Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PALB2, OR
  • Between 18 and 39 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 50 years.
  • Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)

INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)

  • Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Assigned female at birth.
  • 40 years of age and above. OR
  • Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PTEN , PALB2 OR
  • Between 18 and 30 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 35 years.
  • BI-RADS® score of 4B.
  • Scheduled for breast biopsy.

EXCLUSION CRITERIA (BOTH STUDY ARMS)

  • Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.
  • Has received any cancer treatments within the past year.
  • Has participated in another clinical study in the past 30 days.
  • Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.
  • Had a medical procedure in the chest cavity and/or airways within the past 2 weeks which may interfere with the ability to provide a normal breath sample as required by the protocol.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Израиль · 4 центра
  • Rambam Health Care Campus — Haifa
  • Sheba Medical Center — Ramat Gan
  • Assuta Medical Centers — Tel Aviv
  • Tel Aviv Sourasky Medical Center — Tel Aviv
США · 2 центра
  • Hackensack Meridian Health — Totowa
  • Hospital of the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07038785 · P-0001 · Pro2024-0383

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗