Ignite Creation Date:
2025-12-17 @ 1:43 PM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT06979661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-20
First Post:
2025-05-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Circulating Tumor DNA (ctDNA) Post-Surgery', 'timeFrame': 'Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery', 'description': 'This outcome will assess the presence or absence of circulating tumor DNA (ctDNA) in blood samples collected at multiple time points following surgical resection of Stage II-III non-small cell lung cancer (NSCLC). The Haystack™ ctDNA assay will be used to detect minimal residual disease (MRD), and results will be evaluated for their ability to predict recurrence and guide postoperative radiation and systemic therapy decisions.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 3 years post-surgery', 'description': 'This outcome measures the time from surgery to disease progression or recurrence, as determined by imaging, clinical assessment, or rising ctDNA levels detected via the Haystack™ ctDNA assay.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 5 years post-surgery', 'description': 'The time from surgery to death from any cause. This will assess whether ctDNA-guided treatment impacts long-term survival outcomes in patients with Stage II-III NSCLC.'}, {'measure': 'Change in ctDNA Levels Over Time', 'timeFrame': 'Baseline, 2-4 weeks, 3 months, 6 months, and 12 months post-surgery', 'description': 'Measures the change in ctDNA levels detected in serial blood draws, evaluating whether fluctuations correlate with treatment response, recurrence risk, or progression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Non Small Cell Lung Cancer', 'Lung Cancer Recurrent']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nEvaluate the role of ctDNA positivity in decision making for postoperative therapy for non-small cell lung cancer. The plan for postoperative therapy will be declared after pathology report review and before the ctDNA result. We will assess if ctDNA result changed the planned therapy.\n\nSecondary Objectives:\n\nEvaluate personalized postoperative Chemo/ICPI/Targeted Therapies/Radiation Therapy in clearing ctDNA Evaluate the disease-free survival (DFS) and overall survival (OS) of stage II/III lung cancer patients with postoperative ctDNA positive status\n\nExploratory Objective:\n\nEvaluate radiomics features based on serial CT thoracic CT scans to determine if radiomic features can be associated with ctDNA positivity/negativity.', 'detailedDescription': 'This is a pilot, single-arm interventional study evaluating the use of the Haystack™ circulating tumor DNA (ctDNA) assay to guide postoperative radiation therapy (PORT) and systemic therapy decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) who have undergone surgical resection. The study aims to assess whether ctDNA monitoring can effectively detect minimal residual disease (MRD) and improve post-surgical treatment strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have provided signed informed consent for the trial\n2. Aged ≥18 years at the time of informed consent\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n4. Diagnosed with histologically confirmed Stage II-III NSCLC and undergone surgical resection of lung tumor\n5. No active second cancers/malignancy\n6. Patients that received preoperative therapy (including chemotherapy and immunotherapy or others) are eligible\n7. Willing and able to comply with all aspects of the protocol\n8. Standard of care therapy and methods as per institution and investigator discretion -\n\nExclusion Criteria:\n\nExclusion Criteria\n\n1. Discontinued treatment due to a Grade 3 or higher AEs with chemotherapy or immunotherapy or targeted therapy agent\n2. With a history of another primary malignancy within the past 2 years that is considered an active malignancy by the enrolling physician.\n3. Have known active CNS metastases and/or carcinomatous meningitis.\n4. Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.\n5. Have a history of interstitial lung disease.\n6. Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. -"}, 'identificationModule': {'nctId': 'NCT06979661', 'acronym': 'PORT', 'briefTitle': 'Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Trial of ctDNA of Guidance to Determine PostOperative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial', 'orgStudyIdInfo': {'id': '032411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-Arm - ctDNA-Guided Treatment', 'description': 'This single-group interventional arm evaluates the feasibility and impact of ctDNA testing in guiding adjuvant treatment decisions.', 'interventionNames': ['Diagnostic Test: Haystack™ ctDNA Assay']}], 'interventions': [{'name': 'Haystack™ ctDNA Assay', 'type': 'DIAGNOSTIC_TEST', 'description': 'A personalized, tumor-informed circulating tumor DNA (ctDNA) test that analyzes blood samples to detect minimal residual disease (MRD) and guide postoperative treatment decisions for patients with Stage II-III non-small cell lung cancer (NSCLC) following surgical resection. The test results will help determine whether patients should receive postoperative radiation therapy (PORT) and/or systemic therapy adjustments.', 'armGroupLabels': ['Single-Arm - ctDNA-Guided Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'contacts': [{'name': 'Salma Jabbour, MD', 'role': 'CONTACT', 'email': 'jabboursk@cinj.rutgers.edu', 'phone': '732-235-2465'}], 'facility': 'Rutgers Cancer Institute', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'centralContacts': [{'name': 'Salma Jabbour, MD', 'role': 'CONTACT', 'email': 'jabbousk@cinj.rugers.edu', 'phone': '732-235-2465'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiation Oncology', 'investigatorFullName': 'Salma Jabbour, MD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}