Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT05157503
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2020-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '-Evaluate the frequency of decision-making as a standard practice vs with an individual decision', 'timeFrame': '10/01/2023', 'description': '* Percentage of treatment options depending on:\n\n a. The nature of the progression\n* oligo progression\n* systemic progression\n\n b. Prior treatment options v. after surgical treatment\n\n d. Afte'}], 'primaryOutcomes': [{'measure': 'Examine clinical and morphological groups', 'timeFrame': '10/01/2023', 'description': '* gender ratio (husband, wife)\n* smoking status (smoker, non-smoker, past smoker)\n* proportional distribution: squamous cell, adenocarcinoma, dimorphic cancer, others)\n* how many patients with mediastinal lymph node involvement: (N0, N1, N2, N3)\n* detection frequency: PDL (PDL \\<1, PDL\\> 1, PDL \\<49, PDL\\> 50), EGFR (EGFR + (19.24 exon) EGFR-), (ALK +, ALK -), (ROS-1 +, ROS-1 -) Get information about regional algorithms\n* Variants of treatment tactics:\n\nPercentage:\n\na. Surgery\n\nv. Chemotherapy\n\n-Diagnostic algorithm:\n\na. Morphological verification frequency b. The frequency of confirmation of metastatic lesions within the thoracic lymph nodes c. F'}], 'secondaryOutcomes': [{'measure': 'Explore clinical approaches', 'timeFrame': '10/01/2023', 'description': '* Percentage of treatment options depending on:\n\n a. histological type\n* squamous\n* adenocarcinoma\n* dimorphic\n* 3 A st\n* 3B st'}, {'measure': 'Diagnostic algorithm:', 'timeFrame': '10/01/2023', 'description': 'v. from a variant of molecular genetic disorders\n\n* PDL \\<1\n* PDL\\> 1\n* PDL \\<49\n* PDL\\> 50\n* EGFR +'}, {'measure': 'Percentage of treatment options', 'timeFrame': '10/01/2023', 'description': 'from functional status\n\n* ECOG 1\n\n 1. only surgical treatment\n 2. surgical + drug treatment\n 3. surgical + drug treatment + radiation therapy\n 4. drug treatment\n 5. drug treatment + radiation therapy\n 6. radiation therapy\n* ECOG 2\n\n 1. only surgical treatment\n 2. surgical + drug treatment\n 3. surgical + drug treatment + radiation therapy\n 4. drug treatment\n 5. drug treatment + radiation therapy\n 6. radiation therapy\n* ECOG 3\n\n 1. only surgical treatment\n 2. surgical + drug treatment\n 3. surgical + drug treatment + radiation therapy\n 4. drug treatment\n 5. drug treatment + radiation therapy\n 6. radiation therapy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['non-small cell lung cancer'], 'conditions': ['Stage III Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'In connection with the transition to the 8th version of the classification of lung cancer according to the TNM system, there are currently no precise epidemiological data on stage III NSCLC, clinical characteristics of patients in this group, approaches to therapy and treatment results in the Russian Federation. The published statistics only provide information on the overall incidence of stage III lung, trachea and bronchial cancer, which is about 40%. This observational study will make it possible to characterize the Russian population of stage III non-small cell lung cancer patients, approaches to choosing a treatment option for stage III NSCLC and the outcomes of this treatment in real clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with morphologically proven stage III non-small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- stage III non-small cell lung cancer\n\nExclusion Criteria:\n\n\\- the rest of the disease stage'}, 'identificationModule': {'nctId': 'NCT05157503', 'briefTitle': 'Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"', 'organization': {'class': 'OTHER', 'fullName': 'Autonomous Non-Profit Organization National Society of Onco-Pulmonologists'}, 'officialTitle': '"Epidemiology, Approaches to the Diagnosis and Treatment of Patients With Stage III Non-small Cell Lung Cancer in Russia"', 'orgStudyIdInfo': {'id': '4'}}, 'contactsLocationsModule': {'locations': [{'zip': '115478', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'facility': 'National Medical Research Center of Oncology. N. N. Blokhin', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Konstantin Laktionov, Professor', 'role': 'CONTACT', 'email': 'lkoskos@mail.ru', 'phone': '+7-903-170-97-95'}, {'name': 'Valeriy Breder, Leading Researcher', 'role': 'CONTACT', 'email': 'vbreder@yandex.ru', 'phone': '+7-903-199-07-55'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Autonomous Non-Profit Organization National Society of Onco-Pulmonologists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}