Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT06181656
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D008231', 'term': 'Lymphopenia'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706269', 'term': 'SARS-CoV-2 inactivated vaccines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination', 'timeFrame': 'through study completion; an average of 1 year', 'description': 'Serologic responses will be calculated as the average fold change in antibody titer for each of 20 pneumococcal serotypes between baseline (time 0) and the first post-vaccination blood draw.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumococcal Vaccine', 'Esophageal Cancer', 'Lymphopenia', 'Chemoradiation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn how radiation treatment may affect your responses to vaccines against pneumonia.', 'detailedDescription': 'Primary Objectives\n\n\\- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.\n\nSecondary Objectives\n\n* Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination.\n* Determine the impact of radiation modality on serologic responses to pneumococcal vaccination.\n* Determine the impact of radiation modality on systemic immunity.\n* Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine.\n* Determine the impact of radiation modality on pathologic response.\n* Determine the impact of radiation modality on intratumoral immunity.\n* Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response)\n* Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center will enroll 30 esophageal cancer patients. Massachusetts General Hospital in Boston, MA will enroll 30 HCC patients. MD Anderson Cancer Center \\& Massachusetts General Hospital in Boston will jointly enroll up to 20 health volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Group 1A\n\n a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.\n2. Group 1B\n\n a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)\n3. Group 2A\n\n a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.\n4. Group 2B\n\n a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.\n5. Group 3\n\n a. Healthy age- and gender- matched individuals\n6. All Groups\n\n 1. Patients of all genders, races and nationalities will be solicited.\n 2. Age \\>18 years\n 3. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with compromised immunologic responses due to an uncontrolled intercurrent immunodeficiency (e.g., Human immunodeficiency virus (HIV), X-linked agammaglobulinemia) or previous or current immune suppressive therapy\n\n a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.\n* Patients with psychiatric illness/social situations that would limit compliance with study requirements.\n* Individuals with previous pneumococcal vaccination in the last 5 years.\n* Individuals with severe allergy to any of the vaccine components'}, 'identificationModule': {'nctId': 'NCT06181656', 'briefTitle': 'Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation', 'orgStudyIdInfo': {'id': '2023-0370'}, 'secondaryIdInfos': [{'id': 'NCI-2023-10646', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '30 participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer. This group will be subdivided into Group 1A, which will comprise 15 participants treated with proton therapy, and Group 1B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).', 'interventionNames': ['Biological: Pneumonia vaccine']}, {'label': 'Group 2', 'description': '30 participants currently receiving, planning to receive, or recently completed chemoradiation for hepatocellular carcinoma. This group will be subdivided into Group 2A, which will comprise 15 participants treated with proton therapy, and Group 2B, which will comprise 15 patients treated with intensity modulated radiation therapy (IMRT).', 'interventionNames': ['Biological: Pneumonia vaccine']}, {'label': 'Group 3', 'description': '20 Healthy Volunteers.', 'interventionNames': ['Biological: Pneumonia vaccine']}], 'interventions': [{'name': 'Pneumonia vaccine', 'type': 'BIOLOGICAL', 'description': 'Given by SC', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven H Lin, MD', 'role': 'CONTACT', 'email': 'shlin@mdanderson.org', 'phone': '713-563-8490'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Steven H Lin, MD', 'role': 'CONTACT', 'email': 'shlin@mdanderson.org', 'phone': '(713) 563-8490'}], 'overallOfficials': [{'name': 'Steven H Lin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}