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Immunity to Infection in Healthy Participants and Participants With Cancer (SYS01)

U

University Hospital Tuebingen

Status

Active, not recruiting

Conditions

Solid Tumor
Hematologic Malignancy
Influenza
SARS-CoV-2

Treatments

Procedure: Biological sample collection

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Florian Wimmers, Ph.D.

Data sourced from clinicaltrials.gov

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