Immunity to Infection in Healthy Participants and Participants With Cancer

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05787964

Studienbeginn:
Oktober 2022

Letztes Update:
05.04.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Hematologic Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
-

Studienleiter

Claudia Lengerke, Ph.D.
Study Director
University Hospital Tübingen

Florian Wimmers, Ph.D.
Study Director
University Hospital Tuebingen

Kontakt

Florian Wimmers, Ph.D.
Kontakt:
Phone: +49707129
Phone (ext.): 74175
E-Mail: florian.wimmers@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Hopsital Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Florian Wimmers, Ph.D.
Phone: +49707129
Phone (ext.): 74175
E-Mail: florian.wimmers@med.uni-tuebingen.de

Claudia Lengerke, M.D., Ph.D.» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Differences in virus-specific antibody levels (Time Frame - 12 months):
Determination of differences in plasma and serum antibody levels between healthy participants and participants with cancer.

2. Differences in cytokine levels (Time Frame - 12 months):
Determination of differences in plasma and serum cytokine levels between healthy participants and participants with cancer.

3. Differences in immune cell composition (Time Frame - 12 months):
Determination of quantitative, phenotypical, and functional differences in immune cells from healthy participants and participants with cancer.

4. Differences in molecular immune cell makeup (Time Frame - 12 months):
Determination of epigenetic, transcriptional, and proteomic makeup of immune cells from healthy participants and participants with cancer.

Studien-Arme

Healthy participants
Healthy adults aged > 18 years
Participants with haematological malignancies
Multiple myeloma patients receiving lenalidomide and smoldering multiple myeloma patients under observation.
Participants with solid tumours
Stage IV non-small cell lung cancer patients treated with checkpoint inhibitor therapy +/- chemotherapy.

Geprüfte Regime

Biological sample collection:
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.

Quelle: ClinicalTrials.gov

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