Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-30 @ 9:37 AM
Study NCT ID:
NCT07122466
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'ctDNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2025-08-07', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory - Organoid Samples', 'timeFrame': '2 months', 'description': 'If organoid samples are available, compare drug response assessment from organoids to clinical response assessment at 2 months.'}, {'measure': 'Exploratory - Sample Size', 'timeFrame': '6 months', 'description': 'If sample size has enough power, to compare differences in early ctDNA response between regimens (FOLFIRINOX vs Gemcitabine-based treatment, at 3 days and 1 week, respectively)'}], 'primaryOutcomes': [{'measure': 'First follow-up imaging assessment', 'timeFrame': '2 months', 'description': 'Compare first follow-up imaging assessment at 2 months with tumor response as assessed by ctDNA level change from baseline'}], 'secondaryOutcomes': [{'measure': 'ctDNA Assessment Comparison', 'timeFrame': '2 months', 'description': 'Compare ctDNA assessment at 2 months with earlier ctDNA measurements'}, {'measure': 'Compare Signatera ctDNA test', 'timeFrame': '6 months', 'description': 'Compare Signatera ctDNA test with another vendor'}, {'measure': 'ctDNA, CA19-9, & CEA Response', 'timeFrame': '6 months', 'description': 'Compare response of ctDNA with response of CA19-9 and CEA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer'], 'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a study that aims to understand whether a blood test measuring tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA) shows a similar response as observed by a follow-up CT scan. To study this question, ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The proposed sample size of 20 subjects is based on feasibility and availability of resources and not on a formal power calculation. The number of subjects is small, so as to quickly gather data that could inform a larger study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrior/Concurrent Therapy Criteria\n\n1. Patients must be initiating a new treatment regimen for pancreatic cancer at the time of their initiation in the study\n2. Patients must have cytologic or histologic confirmation of pancreatic cancer\n3. Patients must have measurable radiographic evidence of metastatic disease\n4. Patients must be ≥18 years of age\n5. Patients must have an ECOG Performance Status 0-2.\n6. Patients must have adequate organ function for delivery of chemotherapy as evidenced by the following: Hgb ≥8 g/dL, platelets ≥ 75\n7. Patients must not have renal dysfunction that would prevent administration of IV contrast for radiographic assessment.\n\n Regulatory Criteria\n8. Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines.\n9. Patients of all races, genders, \\& ethnicities are eligible.\n\nExclusion Criteria:\n\nNo exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT07122466', 'briefTitle': 'Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Early Treatment ctDNA Dynamics to Predict Response to Chemotherapy in Patients With Advanced Pancreatic Cancer: a Prospective, Observational Pilot Study', 'orgStudyIdInfo': {'id': '23-0286'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tumor DNA circulating in the bloodstream (circulating tumor DNA; ctDNA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'ctDNA will be measured at the same times as CT scans (just before the start of treatment, as well as 2 months after), and the response measured by the ctDNA change will be compared to the response seen on the changes between the CT scans. The goal is to make sure that ctDNA response correlates well with CT scan response measurement.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11042', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Zuckerberg Cancer Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Daniel King, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}