Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
NCT ID: NCT06181656
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2024-02-05
2025-09-30
Brief Summary
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Detailed Description
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\- Determine the impact of Grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination.
Secondary Objectives
* Determine the impact of chemoradiation on serologic responses to pneumococcal vaccination.
* Determine the impact of radiation modality on serologic responses to pneumococcal vaccination.
* Determine the impact of radiation modality on systemic immunity.
* Determine the incidence of pneumonia among patients treated with a pneumococcal vaccine.
* Determine the impact of radiation modality on pathologic response.
* Determine the impact of radiation modality on intratumoral immunity.
* Determine the relationship between changes in systemic and intratumoral immunity and clinical outcomes (i.e., incidence of pneumonia and pathologic response)
* Determine the impact of tumor histology on serologic responses to pneumococcal vaccination.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
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).
Pneumonia vaccine
Given by SC
Group 2
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).
Pneumonia vaccine
Given by SC
Group 3
20 Healthy Volunteers.
Pneumonia vaccine
Given by SC
Interventions
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Pneumonia vaccine
Given by SC
Eligibility Criteria
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Inclusion Criteria
a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons.
2. Group 1B
a. Patients currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT)
3. Group 2A
a. Patients currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma.
4. Group 2B
a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable hepatocellular carcinoma.
5. Group 3
a. Healthy age- and gender- matched individuals
6. All Groups
1. Patients of all genders, races and nationalities will be solicited.
2. Age \>18 years
3. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment.
* Patients with psychiatric illness/social situations that would limit compliance with study requirements.
* Individuals with previous pneumococcal vaccination in the last 5 years.
* Individuals with severe allergy to any of the vaccine components
18 Years
ALL
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Steven H Lin, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2023-10646
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0370
Identifier Type: -
Identifier Source: org_study_id
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