NCT06181656 Serologic Response to Pneumococcal Vaccination Among Esophageal Cancer Patients With High Grade Lymphopenia After Chemoradiation
| NCT ID | NCT06181656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Pneumococcal Vaccine |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-07-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-02-05 with a primary completion date of 2027-07-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To learn how radiation treatment may affect your responses to vaccines against pneumonia.
Eligibility Criteria
Inclusion Criteria: 1. Group 1A 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 liver cancer. 4. Group 2B a. Patients currently receiving, planning to receive, or recently completed definitive IMRT for unresectable liver cancer. 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: * 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 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
Contact & Investigator
Steven H Lin, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06181656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pneumococcal Vaccine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06181656 currently recruiting?
Yes, NCT06181656 is actively recruiting participants. Contact the research team at shlin@mdanderson.org for enrollment information.
Where is the NCT06181656 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06181656 clinical trial?
NCT06181656 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Steven H Lin, MD at M.D. Anderson Cancer Center. The trial plans to enroll 80 participants.