Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 4:02 PM
Study NCT ID:
NCT07255950
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy Between Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "The biopsy results, in a form of 20 cc syringe and slide containing the patient's tissue sample, will be labeled with a code by pulmonologist that will be blinded to the pathologist. The pathologist will then assess the adequacy of the cell count for molecular examination, evaluate the histopathological and cytopathological findings. Statisticians who will process the data are unaware of the allocation of each research item."}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patient undergo the same intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-07-29', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of samples from different types of transthoracal needle aspiration (TTNA) technique', 'timeFrame': 'Immediate after biopsy procedure', 'description': 'To determine the quality of samples between the jabbing-then-suction technique, the suction-with-jabbing technique, and the suction-only technique of transthoracic needle aspiration procedures in patients with unsuspected lung cancer. The sample quality assessed includes the adequacy of the number of tumor cells for molecular examination and the concordance between cytology sample of each type of TTNA technique.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'Non-small cell lung cancer', 'Transthoracal needle aspiration', 'Biopsy', 'Diagnostics'], 'conditions': ['Lung Cancer (Diagnosis)', 'Biopsy, Fine-Needle/Methods']}, 'descriptionModule': {'briefSummary': '* The objective of this research is to determine the accuracy of different types of lung transthoracal needle aspiration (TTNA) i.e. jabbing-then-suction, suction-with-jabbing, and suction-only TTNA in patients with suspected lung cancer.\n* Researchers will compare these techniques to determine whether there are any quality differences in the obtained tumor samples', 'detailedDescription': 'During hospitalization for diagnostic testing, suspected lung cancer patients will undergo a transthoracic biopsy using three TTNA techniques, and core needle biopsy as the gold standard. The biopsy is performed in the operating room under local anesthesia and under the supervision of an anesthesiologist. The biopsy techniques used are routine procedures and therefore not as a new method. After the biopsy is completed, the patient is observed for at least 24 hours to observe potential complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with suspected lung cancer who will undergo diagnostic testing using ultrasound-guided TTNA of the lung with cell block and core biopsy.\n* Patients aged 18-75 years.\n* The tumor is located peripherally, attached to the chest wall.\n\nExclusion Criteria:\n\n* Patient refuses lung biopsy\n* Non-cooperative patient\n* Patient with respiratory failure, on positive pressure ventilation\n* Severe pulmonary emphysema\n* Contralateral pneumonectomy\n* Advanced pulmonary fibrosis\n* Platelet count \\<100,000/mm3 and international normalized ratio (INR) \\>1.4'}, 'identificationModule': {'nctId': 'NCT07255950', 'briefTitle': 'Accuracy Between Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'Accuracy Between Jabbing-then-suction, Suction-with-jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients', 'orgStudyIdInfo': {'id': 'KE/0943/06/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA)', 'interventionNames': ['Diagnostic Test: Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques']}], 'interventions': [{'name': 'Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques', 'type': 'DIAGNOSTIC_TEST', 'description': 'Each of patient will undergo three types of different transthoracal needle aspiration (TTNA)', 'armGroupLabels': ['Jabbing-then-Suction, Suction-with-Jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55291', 'city': 'Yogyakarta', 'state': 'Special Region of Yogyakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'dr. Roihan Mohamad Iqbal', 'role': 'CONTACT', 'email': 'roihan.iqbal@gmail.com', 'phone': '+6285933626780'}, {'name': 'dr. Siswanto, Sp.P(K)Onk', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitas Gadjah Mada Academic Hospital (RSA UGM)', 'geoPoint': {'lat': -7.80139, 'lon': 110.36472}}], 'centralContacts': [{'name': 'dr. Roihan Mohamad Iqbal', 'role': 'CONTACT', 'email': 'roihan.iqbal@gmail.com', 'phone': '+6285933626780'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'IPD and supporting information will be available immediately following publication, without end date.', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) collected during the trial reported in the article will be shared, after deidentification.', 'accessCriteria': 'Requestors who provide a methodologically sound proposal can access the our IPD data. Proposals should be directed to roihan.iqbal@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Siswanto Siswanto', 'investigatorAffiliation': 'Gadjah Mada University'}}}}