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NCT07266194

The Study Will Enroll Females Who Are Coming in for Their Annual Mammogram Screening and Who Are Schedule for a Biopsy to Provide a Breath Sample Via a Mask to Evaluate if Breast Cancer Can be Detected.

Sponsor: Abramson Cancer Center at Penn Medicine

View on ClinicalTrials.gov

Summary

Primary Objective: 1\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women Secondary Objectives: 1. To evaluate the performance of the SpotitEarly in various subgroups. 2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2). 3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure. Exploratory Objective: 1\. To evaluate the test-retest reliability of SpotitEarly's test.

Official title: A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-12-10

Completion Date

2027-01

Last Updated

2025-12-05

Healthy Volunteers

Yes

Conditions

Breast Cancer Detection

Interventions

OTHER

Breathing Mask

Breath sample collection using a sample collection kit

Inclusion Criteria for Arm 1 (Target Population Arm) 1. 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 of breast cancer: BRCA1, BRCA 2, PTEN, TP53, CDH1 or STK11 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. 2. Assign female at birth. 3. Scheduled for routine annual breast cancer screening 4. Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol. Inclusion Criteria for Arm 2 (Enriched Arm) 1. 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 of breast cancer: BRCA1, BRCA 2, PTEN, TP53, CDH1 or STK11 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. 2. Assigned female at birth 3. Scheduled for breast biopsy. 4. BI-RADS® screening score of 4B or above 5. Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol. Exclusion Criteria (Both Arms) 1. Diagnosis with 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 within the last 30 days. 4. Had bilateral surgery 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.