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Recruiting NCT07038785

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Breath test.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Diagnostic test Breath test
    Breath sample collection using a sample collection kit

Primary outcome measures

  • Test Performance Evaluation [Time frame: 24 months]
Secondary outcome measures (4)
  • Test Performance Evaluation in different subgroups [Time frame: 24 months]
  • Test Performance in early-stage cancer [Time frame: 24 months]
  • Test Performance in the clinic vs. at patients' home [Time frame: 24 months]
  • Effect of psychological impacts on performance in the enriched arm [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

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

Identifiers

NCT: NCT07038785 · P-0001 · Pro2024-0383

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗