Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03706235
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colvera for Detection of Disease Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D018962', 'term': 'Phlebotomy'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples are used to isolate cf DNA for identification of methylated markers. Leftover plasma with or without extracted DNA may be kept to repeat assays.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 488}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, specificity, positive predictive value and negative predictive value', 'timeFrame': '1.5 years', 'description': 'on positive or negative Colvera and CEA test results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.', 'detailedDescription': 'This is an observational, prospective comparison study, where blood is collected for assay of methylated BCAT1 and IKZF1 DNA and CEA, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC) and who are in remission and scheduled for follow-up radiological imaging as part of their surveillance program for recurrence. Participation is for one visit only as part of each subject\'s surveillance-monitoring schedule. Two K2-EDTA blood tubes and two PAXgene™ tubes will be collected Any evidence of methylated BCAT1 and/or IKZF1 DNA in blood represents a Colvera "positive" result. CEA levels of 5ug/L or higher will represent a "positive" result. Sensitivity and specificity of the Colvera and CEA test will be estimated and compared in a paired fashion in each case where recurrence status has been investigated and determined by the site clinical management team. Blood testing shall be performed and analyzed by qualified staff blinded to clinical status. This is a cross-sectional observational non-significant risk study, and test results will not be used for clinical management, i.e. there will be no interventions in subjects consenting to participate in this Research Study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'subjects who have undergone curative treatment for primary Colon or rectal cancer of stages II and III (AJCC), and who are in remission and scheduled for clinical follow-up (usually radiological imaging) as part of their surveillance program for recurrence.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is 18 years or older, and capable and willing to provide informed consent.\n2. Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).\n3. Subject has no clinical evidence of disease (NED) (after initial treatment)\n4. Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)\n5. Subject is willing/able to provide a blood sample\n\nExclusion Criteria:\n\n1. Subject has evidence of residual disease.\n2. Subject has other organ cancer at the time of recruitment.\n3. Subject has prior history of recurrent CRC.\n4. Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.\n5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.'}, 'identificationModule': {'nctId': 'NCT03706235', 'acronym': 'NOVA', 'briefTitle': 'Colvera for Detection of Disease Recurrence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinical Genomics Pathology'}, 'officialTitle': 'Evaluation of the Performance of the Clinical Genomics Colvera Test in the Detection of Disease Recurrence in Patients Diagnosed With Colorectal Cancer- "NOVA"', 'orgStudyIdInfo': {'id': 'CG001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No recurrence', 'description': 'Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging. Imaging documents no recurrence.', 'interventionNames': ['Other: Blood draw (venipuncture)']}, {'label': 'Recurrence', 'description': 'Subjects at least 30 days from end of primary treatment for colorectal cancer in a clinically indicated surveillance program (e.g. ASCO, NCCN) provide a blood sample before the next clinically indicated surveillance scan/imaging or imaging has confirmed recurrence. Imaging documents recurrence.', 'interventionNames': ['Other: Blood draw (venipuncture)']}], 'interventions': [{'name': 'Blood draw (venipuncture)', 'type': 'OTHER', 'description': 'Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.', 'armGroupLabels': ['No recurrence', 'Recurrence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Physician Network', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '19901', 'city': 'Dover', 'state': 'Delaware', 'country': 'United States', 'facility': 'Bayhealth', 'geoPoint': {'lat': 39.15817, 'lon': -75.52437}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore Health System', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70001', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Colon and Rectal Surgery Associates', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '48374', 'city': 'Novi', 'state': 'Michigan', 'country': 'United States', 'facility': 'Providence Hospital-Ascension Health', 'geoPoint': {'lat': 42.48059, 'lon': -83.47549}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Virginia Piper Cancer Institute-Allina Health', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '07109', 'city': 'Belleville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Essex Oncology', 'geoPoint': {'lat': 40.79371, 'lon': -74.15014}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'The data collected by recruiting sites is captured without any PHI or identifiers in an Electronic Data Capture system managed for the sponsor by a CRO.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Genomics Pathology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}