Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-01-01 @ 8:04 AM
Study NCT ID:
NCT05187767
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], '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': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'patients serum from peripheral blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-12-24', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of cf DNA', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Assess quantity of the circulating free DNA measured in ng/μL using Qubit 2.0'}, {'measure': 'Presence of ct DNA', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Number of participants with of circulating tumor DNA using a lung pannel for genes: EGFR, KRAS, NRAS, TP53, SKT11, DDR2, PIK3CA, FGFR3, CTNNB1, MET, BRAF, ERBB2, SMAD4, PTEN, AKT, FGFR2, ERBB4, NOTCH1, FGFR1, ALK, IDH1, HRAS, IDH2, PDGFRA, RET, ROS1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer', 'Spreading of Tumor', 'Circulating Tumor Cell']}, 'descriptionModule': {'briefSummary': 'The aim of the study is the early and non-invasive diagnosis of lung cancer in patients with pulmonary ground glass opacity. In particular, objective of the study is to evaluate the presence or absence of circulating tumor DNA (ctDNA) on the peripheral blood of patients with evidence of ground glass opacity(GGO) at CT scan and to evaluate the role that this can play in the diagnostic / therapeutic process. The ctDNA evaluation will be performed at the first radiological finding and subsequently correlated with the malignancy of the lesion based on the radiological / histological criteria regularly used in international protocols.\n\nSecondary objective is the correlation, in patients with malignant GGO undergoing surgical treatment, of the ctDNA presence and tumor spread through the air spaces (STAS), and its correlation with local relapses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with radiological finding of pulmonary ground glass opacity of unknown origin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 18 years\n* radiological finding of pulmonary ground glass opacity\n* absence of solid or haematological tumor\n\nExclusion Criteria:\n\n* radio / chemotherapy treatment for at least 6 months\n* patient unable to understand and express his consent to the study'}, 'identificationModule': {'nctId': 'NCT05187767', 'briefTitle': 'Impact of ctDNA in Cancer Early Detection and STAS Evaluation in Patients With GGOs', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Impact of Circulating Tumor DNA on Early Cancer Detection and Evaluation of STAS in Patients With Ground Glass Opacities', 'orgStudyIdInfo': {'id': 'GGO ctDNA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Malignant GGOs', 'description': 'Patients with histologically proven malignant pulmonary ground glass opacities (GGOs)', 'interventionNames': ['Diagnostic Test: cf DNA and ct DNA']}, {'label': 'Benign GGOs', 'description': 'Patients with histologically or radiologically proven benign pulmonary ground glass opacities (GGOs)', 'interventionNames': ['Diagnostic Test: cf DNA and ct DNA']}], 'interventions': [{'name': 'cf DNA and ct DNA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Quantification of the circulating free DNA and the presence of targeted circulating tumor DNA', 'armGroupLabels': ['Benign GGOs', 'Malignant GGOs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Anile, MD', 'role': 'CONTACT', 'email': 'marco.anile@uniroma1.it', 'phone': '+390649970220'}, {'name': 'Massimiliano Bassi, MD', 'role': 'CONTACT', 'email': 'massimiliano.bassi@uniroma1.it', 'phone': '+390649970220'}], 'facility': 'Thoracic Surgery Unit, Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Marco Anile, MD', 'role': 'CONTACT', 'email': 'marco.anile@uniroma1.it', 'phone': '+390649970220'}], 'overallOfficials': [{'name': 'Marco Anile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Roma La Sapienza'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marco Anile', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}