Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-20 @ 10:22 AM
Study NCT ID:
NCT06527157
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigations of Reproductive Cancers in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Swab samples with DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '12 months', 'description': 'ability to detect cancer'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': '12 months', 'description': 'ability to identify benign cases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uterine Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to create a non-invasive diagnostic test to rule out gynecological cancer in females aged 45 and older with abnormal uterine or postmenopausal bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females 45 years and older seeking medical attention for abnormal uterine or postmenopausal bleeding.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study.\n2. Willing and able to comply with scheduled visits, study plan, and other procedures.\n3. Expected to be available for the duration of the study and can be contacted by telephone during study participation.\n4. Females aged 45 and older (with roughly 80% of enrolled subjects over the age of 50).\n5. Presence of uterus.\n6. AUB or PMB being worked up to diagnose the cause of the bleeding\n\nExclusion Criteria:\n\n1. Investigator site staff members directly involved in the conduct of the study and their family members or subjects who are PinkDx, Inc. employees or their family members.\n2. Other medical or psychiatric conditions that would increase the risk of study participation in the judgement of the Investigator.\n3. Women who have had a hysterectomy.\n4. Women with a known history of endometrial cancer or uterine sarcoma.\n5. Women who have received prior treatment for endometrial cancer.\n6. Inability or unwillingness to sign informed consent.\n7. Clinical suspicion of pregnancy.\n8. Women who have used a tampon within 7 days of sample collection.'}, 'identificationModule': {'nctId': 'NCT06527157', 'acronym': 'PROACTION:', 'briefTitle': 'Investigations of Reproductive Cancers in Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'PinkDx, Inc.'}, 'officialTitle': 'PROspective ACcrual To Investigate reprOductive Cancers in womeN', 'orgStudyIdInfo': {'id': 'PNK002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Benign', 'description': 'sample collection from females with benign causes of AUB/PMB'}, {'label': 'Malignant', 'description': 'sample collection from females with malignant causes of AUB/PMB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Clevenger', 'role': 'CONTACT', 'phone': '205-934-0877'}, {'name': 'Janeen Arbuckle, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94062', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Debbie Jacobs, RN, MSN', 'role': 'CONTACT', 'email': 'debbie.jacobs@sutterhealth.org', 'phone': '916-746-2132'}, {'name': 'John Hoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sutter Health', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jenni Freed, RN', 'role': 'CONTACT', 'email': 'jenni.freed@adventhealth.com'}, {'name': 'Erica Stockwell, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Advent Health Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60045', 'city': 'Lake Forest', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maureen Tart, M.D.', 'role': 'CONTACT', 'phone': '847-234-3250'}], 'facility': 'Ob-Gyne Associates of Lake Forest, Ltd', 'geoPoint': {'lat': 42.25863, 'lon': -87.84063}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelley Dowden', 'role': 'CONTACT', 'email': 'sburn@iu.edu', 'phone': '317-880-3954'}, {'name': 'David M. Haas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University, Eskenazi Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Taylor Rasmusson, M.S.N', 'role': 'CONTACT', 'email': 'rasmusson.taylor@mayo.edu', 'phone': '507-266-4813'}, {'name': 'Andrea Mariani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madison Copeland', 'role': 'CONTACT', 'email': 'm.copeland@wustl.edu', 'phone': '314-362-4672'}, {'name': 'David Mutch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Reena Vattakalam', 'role': 'CONTACT', 'phone': '212-305-3410'}, {'name': 'Jason D Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44304', 'city': 'Akron', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shannon Khoenle', 'role': 'CONTACT', 'phone': '330-375-9753'}, {'name': 'Clarissa Polen-De, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Summa Health', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cindy Overholts', 'role': 'CONTACT', 'email': 'cindy.overholts@osumc.edu', 'phone': '614-293-4365'}, {'name': 'Anne-Marie Sinay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '57108', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kimberlee McKay, MD', 'role': 'CONTACT'}, {'name': 'Kimberlee McKay, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Avera Research Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annette Hickerson', 'role': 'CONTACT', 'email': 'abpayne@uthsc.edu'}, {'name': 'Alexa Swailes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Allison, MPH RN', 'role': 'CONTACT', 'email': 'melissa.allison@mmc.edu', 'phone': '615-327-3108'}], 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer DeVolder, R.N.', 'role': 'CONTACT', 'email': 'Jennifer.DeVolder@bcm.edu', 'phone': '832-822-7406'}, {'name': 'Nishath Ali, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Baylor College of Medicine/Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jaya Kamath, MS', 'role': 'CONTACT', 'email': 'jskamath@houstonmethodist.org', 'phone': '713-441-6616'}, {'name': 'Pedro Ramirez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Krystin Cunningham, RN', 'role': 'CONTACT', 'email': 'cunninghamk3@uthscsa.edu', 'phone': '210-450-8817'}, {'name': 'Sally Kabro, M.Sc.', 'role': 'CONTACT', 'email': 'kabro@uthscsa.edu', 'phone': '708-560-1402'}, {'name': 'Georgia McCann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'VP, Clinical Operations', 'role': 'CONTACT', 'email': 'devon@pinkdx.com', 'phone': '463-273-7024'}], 'overallOfficials': [{'name': 'Andrea Mariani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PinkDx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}