[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07038785":3,"trial-entities:NCT07038785":162,"trial-summary:NCT07038785":177},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":56,"minimum_age":57,"maximum_age":17,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":63,"locations":66,"central_contacts":154,"overall_officials":159,"references":160,"see_also_links":161},"NCT07038785","P-0001","Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs","A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)","RECRUITING","2027-06","2025-08","2026-05-15","2025-07-22","SpotitEarly","INDUSTRY",false,"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.\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.",null,[19],"Breast Cancer",[19,21,22,23],"Screening","Breath Samples","Cancer Detection","OBSERVATIONAL",[],{"count":27,"type":28},1204,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Breath test","Breath sample collection using a sample collection kit",[35,36],"Enriched Arm","Target Population Arm",[38],{"measure":39,"description":40,"timeFrame":41},"Test Performance Evaluation","The test performance will be determined by analysis of the sensitivity and the specificity of the primary endpoint sample set, where sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy), and specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.","24 months",[43,46,49,52],{"measure":44,"description":45,"timeFrame":41},"Test Performance Evaluation in different subgroups","Sensitivity and specificity of the SpotitEarly test will be measured and compared in each of the subgroups:\n\n* Age: under 40, 40-49, 50-64, 65 and older.\n* Race: White, Black\u002FAfrican American, Asian.\n* Ethnicity: hispanic vs. non hispanic\n* Germline pathogenic variant carriers associated with high risk for breast cancer versus non carriers.\n* Smoking status: smokers versus nonsmokers.\n* Women with type-2 diabetes versus not diagnosed with type-2 diabetes Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.",{"measure":47,"description":48,"timeFrame":41},"Test Performance in early-stage cancer","To evaluate the performance (sensitivity and specificity) of the SpotitEarly test in detecting early-stage breast cancer (stages 0-2).\n\nSensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.",{"measure":50,"description":51,"timeFrame":41},"Test Performance in the clinic vs. at patients' home","To evaluate the performance (sensitivity and specificity, as described in 3.4) of the SpotitEarly test over samples provided by participants at their home.\n\nSensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.",{"measure":53,"description":54,"timeFrame":55},"Effect of psychological impacts on performance in the enriched arm","To assess whether the performance (sensitivity and specificity) of the SpotitEarly test is affected by the subject's psychological impacts (anxiety is assumed for all arm 2 subjects who are undergoing a biopsy).\n\nSensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.","12 months","FEMALE","18 Years",true,{"inclusion":60,"exclusion":61,"raw_text":62},[],[],"INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM)\n\n1. 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.\n2. Assigned female at birth.\n3. 40 years of age and above OR\n4. 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\n5. 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.\n6. Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)\n\nINCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)\n\n1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n2. Assigned female at birth.\n3. 40 years of age and above. OR\n4. 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\n5. 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.\n6. BI-RADS® score of 4B.\n7. Scheduled for breast biopsy.\n\nEXCLUSION CRITERIA (BOTH STUDY ARMS)\n\n1. Had 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 in the past 30 days.\n4. Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.\n5. Had a medical procedure in the chest cavity and\u002For airways within the past 2 weeks which may interfere with the ability to provide a normal breath sample as required by the protocol.",[64,65],"ADULT","OLDER_ADULT",[67,85,107,120,132,144],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"Hackensack Meridian Health","Totowa","New Jersey","07512","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Lee Ifhar, MSc, CCRP","CONTACT","551-215-0508","Lee.ifhar@hmhn.org",{"name":80,"role":81},"Elias Obeid, MD, MPH","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},40.9051,-74.20987,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":72,"contacts":90,"geoPoint":104},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",[91,95,99,101],{"name":92,"role":76,"phone":93,"email":94},"Autumn Winch, BS","445-273-2715","Autumn.Winch@pennmedicine.upenn.edu",{"name":96,"role":76,"phone":97,"email":98},"Namaijah Faison","215-829-2224","Namaijah.Faison@pennmedicine.upenn.edu",{"name":100,"role":81},"Brian S Englander, MD",{"name":102,"role":103},"Elizabeth McDonald, MD, PhD","SUB_INVESTIGATOR",{"lat":105,"lon":106},39.95238,-75.16362,{"facility":108,"status":8,"city":109,"country":110,"contacts":111,"geoPoint":117},"Rambam Health Care Campus","Haifa","Israel",[112,116],{"name":113,"role":76,"phone":114,"email":115},"Elizabeth Half, MD","+972-52-5620345","E_Half@rambam.health.gov.il",{"name":113,"role":81},{"lat":118,"lon":119},32.81303,34.99928,{"facility":121,"status":8,"city":122,"country":110,"contacts":123,"geoPoint":129},"Sheba Medical Center","Ramat Gan",[124,128],{"name":125,"role":76,"phone":126,"email":127},"Miri Sklair-Levy, MD","+972-52-6666620","miri.sklairlevy@sheba.health.gov.il",{"name":125,"role":81},{"lat":130,"lon":131},32.08227,34.81065,{"facility":133,"status":8,"city":134,"country":110,"contacts":135,"geoPoint":141},"Assuta Medical Centers","Tel Aviv",[136,140],{"name":137,"role":76,"phone":138,"email":139},"Merav Ben-David, MD","+972-52-6667599","meravak@assuta.co.il",{"name":137,"role":81},{"lat":142,"lon":143},32.08088,34.78057,{"facility":145,"status":8,"city":134,"country":110,"contacts":146,"geoPoint":153},"Tel Aviv Sourasky Medical Center",[147,151],{"name":148,"role":76,"phone":149,"email":150},"Shiran Shapira, PhD","+972-3-6974827","shiransha@tlvmc.gov.il",{"name":152,"role":81},"Nadir Arber, MD",{"lat":142,"lon":143},[155],{"name":156,"role":76,"phone":157,"email":158},"Udi Bobrovsky","+972-54-456-0008","udi@spotitearly.com",[],[],[],{"nct_id":4,"conditions":163,"biomarkers":165},[164],"Breast Carcinoma",[166,167,168,169,170,171,172,173,174,175,176],"BARD1 Gene","BRCA1 Gene","BRCA2 Gene","CDH1 Gene","Partner and Localizer of BRCA2","PTEN Gene","RAD51C Gene","RAD51D Gene","Serine\u002FThreonine-Protein Kinase Chk2","STK11 Gene","TP53 Gene",{"nct_id":4,"found":58,"summary":178,"prompt_version":188},{"design":179,"status":180,"heading":181,"summary":182,"follow_up":183,"word_count":184,"commitments":185,"compensation":186,"drugs_mentioned":187},"This is an observational study aiming to enroll 1204 women. It is designed to evaluate the accuracy of a breath test system.","completed","Breast Cancer Detection Using Dogs and AI","This study is looking into a new way to find breast cancer using trained dogs and artificial intelligence (AI) by analyzing your breath. We are inviting women aged 40 and above, or those assigned female at birth, who are already scheduled for routine breast cancer screening (like a mammogram, ultrasound, or biopsy). To participate, you would simply breathe into a surgical mask to provide a breath sample. This sample will then be checked by trained dogs and an AI system. The goal is to see how well this breath test can detect breast cancer compared to standard medical tests, with results being evaluated over 24 months.","The study will evaluate the test performance over 24 months.",106,"You would provide a breath sample by breathing into a surgical mask. This is done in conjunction with your routine breast cancer screening.","Not stated in the trial record.",[32],"v2"]