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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.

NCT07266194 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Breast Cancer Detection

Interventions

OTHER

Breathing Mask

Breath sample collection using a sample collection kit

Sponsors & Collaborators

  • SpotitEarly

    collaborator INDUSTRY

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Brian S Englander, MD · Penn Medicine

  • Brian S. Englander, MD · Penn Medicine

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2026-12-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266194 on ClinicalTrials.gov