NCT05787964

Brief 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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

March 15, 2023

Last Update Submit

May 8, 2024

Conditions

InfluenzaSARS-CoV-2Hematologic MalignancySolid Tumor

Outcome Measures

Primary Outcomes (4)

  • Differences in virus-specific antibody levels

    Determination of differences in plasma and serum antibody levels between healthy participants and participants with cancer.

    12 months

  • Differences in cytokine levels

    Determination of differences in plasma and serum cytokine levels between healthy participants and participants with cancer.

    12 months

  • Differences in immune cell composition

    Determination of quantitative, phenotypical, and functional differences in immune cells from healthy participants and participants with cancer.

    12 months

  • Differences in molecular immune cell makeup

    Determination of epigenetic, transcriptional, and proteomic makeup of immune cells from healthy participants and participants with cancer.

    12 months

Study Arms (3)

Healthy participants

Healthy adults aged \> 18 years

Procedure: Biological sample collection

Participants with haematological malignancies

Multiple myeloma patients receiving lenalidomide and smoldering multiple myeloma patients under observation.

Procedure: Biological sample collection

Participants with solid tumours

Stage IV non-small cell lung cancer patients treated with checkpoint inhibitor therapy +/- chemotherapy.

Procedure: Biological sample collection

Interventions

Biological sample collectionPROCEDURE

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.

Healthy participantsParticipants with haematological malignanciesParticipants with solid tumours

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopsital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be drawn from participants, and different fractions will be isolated and cryopreserved, including peripheral blood mononuclear cells (PBMCs), plasma, serum, and RNA (in PAXgene tubes).

MeSH Terms

Conditions

Influenza, HumanHematologic Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Claudia Lengerke, Ph.D.

    University Hospital Tübingen

    STUDY DIRECTOR

  • Florian Wimmers, Ph.D.

    University Hospital Tuebingen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

October 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-04

Locations

DE(1)