Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT03517332
Status:
UNKNOWN
Last Update Posted:
2018-11-20
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA Exposure in Peripheral Blood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Circulating tumor DNA in blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-16', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-24', 'lastUpdatePostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study', 'timeFrame': '28 Months', 'description': 'The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Pancreatic Adenocarcinoma', 'Gastric Cancer', 'Hepatocellular Carcinoma', 'Non-small Cell Lung Cancer', 'Bladder Cancer', 'Melanoma', 'Ovarian Cancer', 'Adrenocortical Cancer', 'Breast Cancer', 'Other Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).', 'detailedDescription': 'This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Subjects that are diagnosed with a malignancy (cohort 1)\n* Subjects that have not been diagnosed with a malignancy (cohort 2)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study will include subjects that are diagnosed with a malignancy (cohort\n\n 1\\) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).\n* Subjects of both cohorts must:\n\n * Be of age ≥ 18\n * Provide written consent for study participation\n* Subject of cohort 1 must:\n\n * Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma\n\nSubjects of cohort 2 must:\n\n• Meet the listed matching criteria\n\nExclusion Criteria:\n\n* Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy\n* Subjects of cohort 2 must not:\n\n * Have been diagnosed/treated for a malignancy previously'}, 'identificationModule': {'nctId': 'NCT03517332', 'briefTitle': 'Circulating Tumor DNA Exposure in Peripheral Blood', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quantgene Inc.'}, 'officialTitle': 'Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study', 'orgStudyIdInfo': {'id': 'QG01012015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma\n\nSubjects of cohort 1 must not:\n\n• Have been treated for above diagnosed malignancy'}, {'label': 'Cohort 2', 'description': 'Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).\n\nSubjects of cohort 2 must:\n\n• Meet the listed matching criteria\n\nSubjects of cohort 2 must not:\n\n• Have been diagnosed/treated for a malignancy previously'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '34747', 'city': 'Celebration', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lorraine Hickson, MRA', 'role': 'CONTACT'}, {'name': 'Olga Ivanov, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Hospital Celebration Health', 'geoPoint': {'lat': 28.32529, 'lon': -81.53313}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vernique Walker', 'role': 'CONTACT'}, {'name': 'Debashish Bose, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Health UF Health Cancer Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Ouellette, D.O.', 'role': 'CONTACT'}, {'name': 'James Ouellette, D.O', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Premier Surgical Oncology', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '45429', 'city': 'Dayton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Molly Regan', 'role': 'CONTACT'}, {'name': 'Minia Hellan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kettering Medical Center', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Pamela Sun, M.D.', 'role': 'CONTACT'}, {'name': 'Frederic Ris, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nicolas C Buchs, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'centralContacts': [{'name': 'Monika Hagen, M.D.', 'role': 'CONTACT', 'email': 'mh@quantgene.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quantgene Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}