Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-27 @ 1:03 AM
Study NCT ID:
NCT00864266
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2009-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'response will be assessed every 3 cycles of chemotherapy according to WHO criteria'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Survival will be dated from the date of treatment'}, {'measure': 'Progression-free survival', 'timeFrame': 'Period between the date of treatment and the date of first progression or death'}, {'measure': 'Duration of response', 'timeFrame': 'period between the day of treatment and the date of first progression in patients with an objective response'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non small cell lung carcinoma', 'Chemotherapy', 'Response prediction'], 'conditions': ['Non Small Cell Lung Carcinoma']}, 'referencesModule': {'references': [{'pmid': '25674536', 'type': 'DERIVED', 'citation': 'Berghmans T, Ameye L, Lafitte JJ, Colinet B, Cortot A, CsToth I, Holbrechts S, Lecomte J, Mascaux C, Meert AP, Paesmans M, Richez M, Scherpereel A, Tulippe C, Willems L, Dernies T, Leclercq N, Sculier JP; European Lung Cancer Working Party. Prospective Validation Obtained in a Similar Group of Patients and with Similar High Throughput Biological Tests Failed to Confirm Signatures for Prediction of Response to Chemotherapy and Survival in Advanced NSCLC: A Prospective Study from the European Lung Cancer Working Party. Front Oncol. 2015 Jan 28;4:386. doi: 10.3389/fonc.2014.00386. eCollection 2014.'}, {'pmid': '24007627', 'type': 'DERIVED', 'citation': 'Berghmans T, Ameye L, Willems L, Paesmans M, Mascaux C, Lafitte JJ, Meert AP, Scherpereel A, Cortot AB, Cstoth I, Dernies T, Toussaint L, Leclercq N, Sculier JP; European Lung Cancer Working Party. Identification of microRNA-based signatures for response and survival for non-small cell lung cancer treated with cisplatin-vinorelbine A ELCWP prospective study. Lung Cancer. 2013 Nov;82(2):340-5. doi: 10.1016/j.lungcan.2013.07.020. Epub 2013 Aug 7.'}], 'seeAlsoLinks': [{'url': 'http://www.elcwp.org', 'label': '(Click here for more information on the protocol)'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of non-small-cell lung cancer (NSCLC)\n* Obtention of a biopsy of the tumour according to the procedure defined in the protocol\n* NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)\n* Presence of at least one assessable lesion\n* Availability for participating in the detailed follow-up of the protocol\n* Signed informed consent.\n* Age above 18 years\n\nExclusion Criteria:\n\n* Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC\n* NSCLC treated by exclusive surgery or radiotherapy\n* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)'}, 'identificationModule': {'nctId': 'NCT00864266', 'briefTitle': 'Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'European Lung Cancer Working Party'}, 'officialTitle': 'Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study', 'orgStudyIdInfo': {'id': '01082'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org)', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5004', 'city': 'Bouge', 'country': 'Belgium', 'facility': 'Department of Pneumology Clinique Saint-Luc', 'geoPoint': {'lat': 50.47193, 'lon': 4.89218}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Service de Pneumologie Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6060', 'city': 'Gilly', 'country': 'Belgium', 'facility': 'Department of Pneumology Hôpital Saint-Joseph', 'geoPoint': {'lat': 50.42449, 'lon': 4.4789}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Hôpital Ambroise Paré', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '7700', 'city': 'Mouscron', 'country': 'Belgium', 'facility': 'Department of Pneumology Centre Hospitalier de Mouscron', 'geoPoint': {'lat': 50.74497, 'lon': 3.20639}}], 'overallOfficials': [{'name': 'Thierry Berghmans, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Lung Cancer Working Party'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Lung Cancer Working Party', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}