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Trial Title:
Immunity to Infection in Healthy Participants and Participants With Cancer
NCT ID:
NCT05787964
Condition:
Influenza
SARS-CoV-2
Hematologic Malignancy
Solid Tumor
Conditions: Official terms:
Hematologic Neoplasms
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biological sample collection
Description:
Whole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis
of samples. Collection of biologic samples will occur up to 12 months.
Arm group label:
Healthy participants
Arm group label:
Participants with haematological malignancies
Arm group label:
Participants with solid tumours
Summary:
Many cancer patients are highly susceptible to infection and respond poorly to
vaccination. This observational study will determine molecular and cellular features of
immunity to viral pathogens in participants with cancer and compare them to healthy
controls. The aim is to identify how antiviral immunity in participants with cancer
differs from that in healthy participants to understand why cancer patients are more
susceptible to infections. In this context, the investigators will also evaluate immunity
to medically indicated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and
seasonal influenza vaccine received by study participants during standard care (vaccines
are not part of the study).
Detailed description:
Cancer and its treatments are associated with dysregulated immune systems, and cancer
patients are highly susceptible to infections (e.g., influenza, SARS-CoV-2). Importantly,
cancer patients often respond poorly to vaccination. The molecular and cellular
mechanisms underlying immune dysregulation and poor immunity in cancer patients are
manifold, variable among individual patients/conditions, and poorly understood. An
in-depth understanding of these mechanisms is essential to identifying novel strategies
to prevent infectious diseases and developing individualized therapies.
In this observational study, the investigators will collect blood samples from 200
participants with hematological and oncological malignancies and healthy participants and
analyze the cellular and humoral immune status in the context of SARS-CoV-2 and influenza
infection and vaccination within these samples using systems biological tools. Medically
indicated vaccination against SARS-CoV-2 and influenza during study participation is
allowed.
This study aims to (1) examine the fundamental innate, cellular, and humoral immune
responses to pathogens that form the basis of immunological memory and (2) identify
molecular and cellular mechanisms responsible for the reduced immune immunity to viral
pathogens in participants with cancer.
Criteria for eligibility:
Study pop:
Participants with cancer will be drawn from the local clinics at the University Hospital
Tübingen. Healthy participants will be recruited from university and hospital employees
not associated with the study.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- You are aged 18 years or older.
- You are able to understand and give informed consent.
- Participants with cancer: you are suffering from cancer
- Healthy participants: you are a healthy individual.
Exclusion Criteria:
- You are unable to give informed consent.
- You have been suffering from an acute infection with fever during the last three
days.
- You have a Hb level of less than 9 g/dl.
- You have a human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University Hopsital Tuebingen
Address:
City:
Tuebingen
Zip:
72076
Country:
Germany
Start date:
October 1, 2022
Completion date:
September 1, 2024
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05787964
