Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-30 @ 6:44 PM
Study NCT ID:
NCT04858568
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses to COVID-19 Vaccination in Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma Serum Peripheral blood mononuclear cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 592}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time.', 'timeFrame': '12 months', 'description': 'To evaluate the robustness and persistence of anti-S IgG levels.'}], 'secondaryOutcomes': [{'measure': 'Comparison between SARS-CoV-2 IgG responses with clinical parameters.', 'timeFrame': '12 months', 'description': 'Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment.'}, {'measure': 'Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.', 'timeFrame': '12 months', 'description': 'To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Classical Hodgkin Lymphoma', 'Diffuse Large B Cell Lymphoma', 'Primary Mediastinal B Cell Lymphoma', 'High-grade B-cell Lymphoma', 'Burkitt Lymphoma', 'Follicular Lymphoma', 'Mantle Cell Lymphoma', 'Marginal Zone Lymphoma', 'Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma', 'Lymphoplasmacytic Lymphoma', 'Nodular Lymphocyte Predominant Hodgkin Lymphoma', 'Peripheral T-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '35332334', 'type': 'DERIVED', 'citation': "Lim SH, Stuart B, Joseph-Pietras D, Johnson M, Campbell N, Kelly A, Jeffrey D, Turaj AH, Rolfvondenbaumen K, Galloway C, Wynn T, Coleman AR, Ward B, Long K, Coleman H, Mundy C, Bates AT, Ayres D, Lown R, Falconer J, Brake O, Batchelor J, Willimott V, Bowzyk Al-Naeeb A, Robinson L, O'Callaghan A, Collins GP, Menne T, Faust SN, Fox CP, Ahearne M, Johnson PWM, Davies AJ, Goldblatt D. Immune responses against SARS-CoV-2 variants after two and three doses of vaccine in B-cell malignancies: UK PROSECO study. Nat Cancer. 2022 May;3(5):552-564. doi: 10.1038/s43018-022-00364-3. Epub 2022 Mar 24."}]}, 'descriptionModule': {'briefSummary': 'This prospective observational study aims to evaluate the robustness and persistence of immune responses to vaccination, define factors associated with impaired immune responses and assess the incidence of COVID-19 infections in vaccinated individuals. To do this, we will collect peripheral blood from patients with lymphoid cancers before and after their COVID-19 vaccination. The blood will be explored in the laboratory for antibodies to SARS-CoV-2 and T-cell responses to the spike protein. Detailed clinical information will also be collated on about their cancer and treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA\n\n1. Patients having a confirmed diagnosis of either:\n\n A) Hodgkin lymphoma B) Aggressive B-cell lymphoma (e.g. Burkitt's lymphoma, diffuse large B-cell lymphoma, grade 3b follicular lymphoma, de novo transformed follicular lymphoma) C) Indolent B-cell lymphoma (e.g. all grades of follicular lymphoma except grade 3b, marginal zone lymphoma, lymphoplasmacytic lymphoma, chronic or small lymphocytic lymphoma, mantle cell lymphoma) D) Mature T/NK-cell malignancy (any subtype)\n2. Patient must be ≥ 18 years.\n3. Patients will have provided written Informed Consent.\n\nEXCLUSION CRITERIA\n\n1\\) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent."}, 'identificationModule': {'nctId': 'NCT04858568', 'acronym': 'PROSECO', 'briefTitle': 'Immune Responses to COVID-19 Vaccination in Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Southampton NHS Foundation Trust'}, 'officialTitle': 'PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer', 'orgStudyIdInfo': {'id': 'RHM CAN1612'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hodgkin lymphoma', 'description': 'Diagnoses:\n\nHodgkin lymphoma (classical Hodgkin lymphoma)'}, {'label': 'Aggressive B-NHL', 'description': 'Diagnoses:\n\nAggressive B-NHL (E.g. Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, Burkitt lymphoma, de novo transformed lymphoma, follicular lymphoma grade 3b)'}, {'label': 'Indolent B-NHL', 'description': 'Diagnoses:\n\nIndolent B-NHL (E.g.follicular lymphoma grades 1-3a, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, nodular lymphocyte predominant Hodgkin lymphoma)'}, {'label': 'Peripheral T/NK-cell', 'description': 'Diagnoses:\n\nPeripheral T/NK-cell lymphomas (any mature T/NK cell malignancy)'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'MK42 9DJ', 'city': 'Bedford', 'state': 'Bedfordshire', 'country': 'United Kingdom', 'facility': 'Bedfordshire Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}, {'zip': 'PO6 3LY', 'city': 'Portsmouth', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Portsmouth Hospitals University NHS Trust', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'HR1 2ER', 'city': 'Hereford', 'state': 'Herefordshire', 'country': 'United Kingdom', 'facility': 'Wye Valley NHS Trust', 'geoPoint': {'lat': 52.05684, 'lon': -2.71482}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'University Hospitals of Leicester NHS Trust', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'The Newcastle Upon Tyne Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Southampton NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}