UPCC 05125 A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The Pink Study) (PINK)

Research Study on Detecting Breast Cancer Using Breath Samples

Enrolling By Invitation
18 years or above
Female
Phase N/A
1204 participants needed
1 Location

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years or above
  • Gender: Female

INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)

  1. 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.
  2. Assigned female at birth.
  3. 40 years of age and above OR
  4. 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
  5. 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.
  6. Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)

INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)

  1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  2. Assigned female at birth.
  3. 40 years of age and above. OR
  4. 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
  5. 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.
  6. BI-RADS® score of 4B.
  7. Scheduled for breast biopsy.

EXCLUSION CRITERIA (BOTH STUDY ARMS)

  1. Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.
  2. Has received any cancer treatments within the past year.
  3. Has participated in another clinical study in the past 30 days.
  4. Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.
  5. 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.

This study investigates the use of trained detection dogs and artificial intelligence (AI) to identify breast cancer from a person's breath. The purpose of this study is to understand if this method can accurately detect breast cancer in women who are scheduled for routine screening, such as mammograms, ultrasounds, or biopsies. Participants will be asked to breathe into a surgical mask to collect a breath sample.

The collected breath sample will be analyzed by trained dogs and an AI-based system in a specialized laboratory. The results from these analyses will be compared to the actual medical screening or biopsy results to determine the accuracy of this detection method. This study aims to validate the effectiveness of using breath samples in identifying breast cancer.

  • Who can participate: Women aged 40 and above, or those between 18 and 39 with a high risk for breast cancer due to genetic factors or family history, are eligible. Participants must be scheduled for routine breast cancer screening or a biopsy. They must also be able to provide informed consent.
  • Study details: Participants will breathe into a surgical mask to provide a breath sample. This sample will be sent to a laboratory where trained dogs and an AI system will analyze it for signs of breast cancer. The results will be compared to standard screening results to assess accuracy.
Updated on 15 May 2026. Study ID: 25-1503
If you need assistance finding a non-cancer clinical research study or if you have any questions, please email psom-ocr@pobox.upenn.edu For Cancer trials contact Penn Medicine's Cancer Trial Navigator at: PMCancerResearch@pennmedicine.upenn.edu or 215-349-8245

Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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