Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-20 @ 11:40 AM
Study NCT ID:
NCT07266194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Exhaled breath samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-12-03', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specifically of the SpotitEarly testing in each of the subgroups', 'timeFrame': '12 months', 'description': 'Age: under 40, 40-49, 50-64, 65 and older. Race: White, Black/African American, Asian and Pacific Islander, Native American/ Alaska Native, more than one race.\n\nGermline pathogenic variant carriers associated with high risk for breast cancer (BRCA1, BRCA2, PTEN, TP53, CDH1, STK11) versus non-carriers.\n\nSmoking status: smokers versus non-smokers. Women with type-2 diabetes versus women who were not diagnosed with the disease.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of the SpotitEarly test in detecting early-stage cancer among breast cancer-positive samples', 'timeFrame': '24 months', 'description': "he test's specificity and its confidence interval (CI) will be analyzed in the following subgroups: Negative non-benign samples in Arm 1. All benign samples in Arm 1. Benign samples in Arm 1 of participants with a BI-RADS® score of 4B or above. Benign samples in Arm 2."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Screening', 'Breath Samples', 'Cancer Detection'], 'conditions': ['Breast Cancer Detection']}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\n1\\. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women\n\nSecondary Objectives:\n\n1. To evaluate the performance of the SpotitEarly in various subgroups.\n2. To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).\n3. To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.\n\nExploratory Objective:\n\n1\\. To evaluate the test-retest reliability of SpotitEarly's test.", 'detailedDescription': "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 screening breast cancer screening, 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible subjects who are seen at Pennsylvania Hospital for their breast cancer screening and biopsy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Arm 1 (Target Population Arm)\n\n1. 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.\n2. Assign female at birth.\n3. Scheduled for routine annual breast cancer screening\n4. Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol.\n\nInclusion Criteria for Arm 2 (Enriched Arm)\n\n1. 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.\n2. Assigned female at birth\n3. Scheduled for breast biopsy.\n4. BI-RADS® screening score of 4B or above\n5. Capable of giving consent for self, which includes compliance with the requirements and restriction listed in the Informed Consent and in the protocol.\n\nExclusion Criteria (Both Arms)\n\n1. Diagnosis with cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.\n2. Has received any cancer treatments within the past year.\n3. Has participated in another clinical study within the last 30 days.\n4. Had bilateral surgery for breast cancer or for preventive reasons related to breast cancer.\n5. 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.'}, 'identificationModule': {'nctId': 'NCT07266194', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer', 'orgStudyIdInfo': {'id': '859242'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Target Population Arm', 'description': 'Women scheduled for routine breast cancer screening.', 'interventionNames': ['Other: Breathing Mask']}, {'label': 'Enriched Arm', 'description': 'Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above', 'interventionNames': ['Other: Breathing Mask']}], 'interventions': [{'name': 'Breathing Mask', 'type': 'OTHER', 'description': 'Breath sample collection using a sample collection kit', 'armGroupLabels': ['Enriched Arm', 'Target Population Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Autumn Winch, BS', 'role': 'CONTACT', 'email': 'Autumn.Winch@pennmedicine.upenn.edu', 'phone': '445-273-2715'}, {'name': 'Namaijah Faison, MS', 'role': 'CONTACT', 'email': 'Namaijah.Faison@pennmedicine.upenn.edu', 'phone': '215-829-2224'}], 'overallOfficials': [{'name': 'Brian S Englander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn Medicine'}, {'name': 'Brian S. Englander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'SpotitEarly', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Radiology at Pennsylvania Hospital', 'investigatorFullName': 'Brian Englander', 'investigatorAffiliation': 'Abramson Cancer Center at Penn Medicine'}}}}