Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
Study NCT ID:
NCT04145232
Status:
UNKNOWN
Last Update Posted:
2020-08-10
First Post:
2019-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'biopsy (FFPE), peripheral blood samples (PBMC) and stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2019-10-29', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)', 'timeFrame': 'Up to 6 months', 'description': 'Standard follow-up care after cancer treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Non Small Cell Lung Cancer', 'Neoepitopes', 'Neoantigens', 'Immunotherapy', 'Nivolumab', 'Ipilimumab', 'Atezolizumab', 'Neoantigen cancer vaccine', 'Personalized neoantigen cancer vaccine', 'FFPE', 'PBMC', 'Stool', 'Immuno-Oncology', 'Next generation sequencing (NGS)'], 'conditions': ['Non Small Cell Lung Cancer', 'Neoepitopes', 'Neoantigens', 'Immunotherapy', 'Next Generation Sequencing (NGS)', 'Personalized Neoantigen Cancer Vaccine']}, 'descriptionModule': {'briefSummary': "The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.\n\nA key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.\n\nThe samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving routine treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women ≥18 years of age.\n* Patients with non-small cell lung cancer.\n* Patients with informed consent to participate in the study.\n* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).\n* The applied immunotherapy should be the first or second line of treatment.\n\nExclusion Criteria:\n\n* Patients who are unable to understand, read and / or sign informed consent.\n* Patients who can not collect stools.\n* Patients with fecal transplant.\n* The applied immunotherapy is not the first or second line of treatment.'}, 'identificationModule': {'nctId': 'NCT04145232', 'briefTitle': "AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardigen'}, 'officialTitle': 'Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy', 'orgStudyIdInfo': {'id': 'A.I.mmune'}, 'secondaryIdInfos': [{'id': 'RPMP.01.02.01-12-0301/17', 'type': 'OTHER_GRANT', 'domain': 'Małopolskie Centre of Entrepreneurship'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSCLC', 'description': 'This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).', 'interventionNames': ['Biological: Collection of biopsy (FFPE), blood (PBMC) and stool']}], 'interventions': [{'name': 'Collection of biopsy (FFPE), blood (PBMC) and stool', 'type': 'BIOLOGICAL', 'otherNames': ['Nivolumab', 'Ipilimumab', 'Atezolizumab'], 'description': 'Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).', 'armGroupLabels': ['NSCLC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'University Clinical Centre in Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Martyna Balawejder', 'role': 'CONTACT', 'email': 'martyna.balawejder@ardigen.com', 'phone': '+48 883 319 890'}, {'name': 'Bozena Augustyn', 'role': 'CONTACT', 'email': 'bozena.augustyn@ardigen.com', 'phone': '+48 12 340 94 94'}], 'overallOfficials': [{'name': 'Piotr Stepniak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ardigen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardigen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Małopolskie Centre of Entrepreneurship', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}