Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT04960059
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2021-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2021-07-02', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Retrospective mapping of immune-related adverse events with cytokine concentrations over time by in-home DBS sampling.', 'timeFrame': '12 months', 'description': 'The association between these statistics and the development of immune-related adverse events will be estimated using a logistic regression analysis.'}, {'measure': 'Patient reported outcomes from semi-structured interviews.', 'timeFrame': '12 months', 'description': 'The patient satisfaction level will be assessed by survey interviews.'}], 'primaryOutcomes': [{'measure': 'Patient adherence to protocol defined DBS time points.', 'timeFrame': '12 months', 'description': 'the number of DBS samples successfully collected against the number of total expected samples'}, {'measure': 'Number of in-home DBS samples passing quality assurance checks in patients receiving CPI therapy by multi-cytokine ELISA.', 'timeFrame': '12 months', 'description': 'the number of DBS samples passing quality assurance checks against the number of DBS samples successfully collected.'}], 'secondaryOutcomes': [{'measure': 'Compare cytokine concentrations by DBS sampling and intravenous blood sampling by multi-cytokine ELISA.', 'timeFrame': '12 months', 'description': 'The changes of cytokine concentrations will be estimated by the log-ratio of cytokine concentrations measured at two time points. The trend of cytokine concentration during treatment will be estimated by fitting a linear regression model based on all cytokine concentrations collected during treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'immune related adverse event', 'cytokine release'], 'conditions': ['Cancer', 'Metastatic Melanoma', 'Renal Cell Carcinoma', 'Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study will explore the ability of patients on first line combination immunotherapy to sample cytokines at home. The data from this study will be used to evaluate the feasibility of in-home testing and the ability to analyse patients cytokine profiles retrospectively to help feed the development of further studies.', 'detailedDescription': 'Patients will be informed of the study and given a minimum of 24 hours to consider. Once consented patients will enter the study where they will take cytokine samples at home over a 12 week period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving checkpoint inhibitor therapy as first line treatment of renal cell carcinoma, metastatic melanoma or non-small cell lung cancer (in combination with chemotherapy for NSCLC).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary informed consent.\n* Aged at least 18 years.\n* Diagnosis of locally advanced or metastatic RCC, Melanoma or NSCLC\n* In the opinion of the investigator deemed suitable to receive first-line combination immunotherapy (RCC and MM) or combination immunotherapy and chemotherapy (NSCLC).\n* Willingness to comply with scheduled trial procedures.\n* Capable of performing own dry blood sampling procedure, or a carer who is willing and able to perform them.\n\nExclusion Criteria:\n\n* Previous immunotherapy (including any CPI either as single agent on in combination, or high dose interleukin-2).\n* Judgement by the investigator that the individual should not participate if they are unlikely to comply with study procedures and requirements.\n* Patients receiving long term oral anticoagulation deemed by the clinician to be at risk from daily finger pricking.'}, 'identificationModule': {'nctId': 'NCT04960059', 'briefTitle': 'NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts', 'organization': {'class': 'OTHER', 'fullName': 'The Christie NHS Foundation Trust'}, 'officialTitle': 'NOTION: iN-home Sampling Of cyTokines in ImmunOtherapy patieNts', 'orgStudyIdInfo': {'id': 'CFTSp181'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This is an observational study'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Leanna Goodwin', 'role': 'CONTACT', 'email': 'the-christie.notion@nhs.net', 'phone': '07881842794'}, {'name': 'Donna Graham', 'role': 'CONTACT', 'email': 'donna.graham8@nhs.net'}], 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'centralContacts': [{'name': 'Donna Graham, MD', 'role': 'CONTACT', 'email': 'donna.graham8@nhs.net', 'phone': '07881842794'}, {'name': 'Hannah Frost', 'role': 'CONTACT', 'email': 'hannah.frost@digitalecmt.org', 'phone': '07881842794'}], 'overallOfficials': [{'name': 'Donna Graham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Christie NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Manchester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}