Esophageal Cancer Clinical Trial
Official title:
Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Group 1A a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with protons. 2. Group 1B a. Participants currently receiving, planning to receive, or recently completed chemoradiation for esophageal cancer with intensity-modulated radiation therapy (IMRT) 3. Group 2A a. Participants currently receiving, planning to receive, or recently completed definitive proton therapy for unresectable hepatocellular carcinoma. 4. Group 2B a. Participants 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. Participants 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: - Participants 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 a. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. - Participants receiving intravenous immunoglobulin (IVIG) during the study or in the three months prior to study enrollment. - Participants with psychiatric illness/social situations that would limit compliance with study requirements. - Participants with previous pneumococcal vaccination - Participants with severe allergy to any of the vaccine components |
Country | Name | City | State |
---|---|---|---|
United States | MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of grade IV radiation-induced lymphopenia on serologic responses to pneumococcal vaccination | 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. | through study completion; an average of 1 year |
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