COVID-19 in Cancer Patients: Evaluation of Clinical Course and Impact on Oncological Care Including Biobanking

NCT ID: NCT04408339

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-15

Study Completion Date

2022-04-14

Brief Summary

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The COVIDHELP study will prospectively evaluate the yet unknown clinical course of the COVID-19 infection in cancer patients and document the impact of potential infrastructural limitations on cancer care of COVID-19 positive patients. All patients consenting will provide peripheral blood samples for prospective biobanking with the aim of investigating immune response and immunity against COVID-19.

Detailed Description

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Based on patients, who are treated in the University Cancer Center Hamburg (UCCH) and its contracted partner network, which comprises all cancer treating departments at the University Medical Center of Hamburg-Eppendorf (UKE), as well as 19 office-based oncologists and 20 surrounding hospitals, recruitment for the study will be done as follows:

(i) as a cancer patient during regular aftercare appointments who reports a current or past COVID-19 infection.

(ii) as an acute COVID-19 patient who reports a prevalent cancer diagnosis

Data will be collected as available from routine clinical care and includes demographic and biometric data, medical history, baseline data at inclusion as well as inpatient and intensive care unit admissions. Upon consent, patients will provide peripheral blood samples at time of inclusion and after 6 month. Recruitment is limited to a one-year period (April 2020 - April 2021).

Conditions

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Cancer COVID

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Known diagnosis of cancer
* Known diagnosis of CoVID-19 infection
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria

• refusal of participation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hopsital Schleswig Holstein Campus Lübeck

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katja Weisel, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center of Hamburg-Eppendorf

Locations

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University Hospital Hamburg Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Katja Weisel, MD

Role: CONTACT

+49407410 ext. 58787

Niklas Boerschel, MD

Role: CONTACT

+49407410 ext. 51410

Facility Contacts

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S Guengoer

Role: primary

Other Identifiers

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PV7313

Identifier Type: -

Identifier Source: org_study_id

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