COVID-19 Infection in Cancer Pantients

NCT ID: NCT04569292

Last Updated: 2020-09-29

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-08-31

Brief Summary

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It's an obsevational retrospective/prospective study. Analyzing the evolution of COVID 19 infection in cancer patients can provide interesting information in the management of these patients. For this reason, the purpose of this study is to implement a registry to describe and monitor cancer patients affected by COVID 19, the factors that are associated with an unfavorable evolution, to develop a strategy for the risk assessment of these patients and recommendations. relating to their treatment.

Particular attention will be paid to patients suffering from urological tumors because the treatment followed by the patients would seem to expose them to a greater risk when they are infected with coronavirus, furthermore, from the literature it is clear that there may be a connection between sex hormones and ACE2 levels in the plasma. In fact, the estrons up-regulate the concentration of ACE2 in the circulation and this could be the reason why women would seem more protected than men once they contract the coronavirus infection

Detailed Description

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Primary objectives:

* describe cancer patients with COVID-19 and their clinical course;
* identify predictors of the most severe clinical course;
* identify prognostic factors; Secondary objectives
* Monitor patients with urological tumors with particular attention;
* Dosing parameters of inflammation such as IL-6 and IFNα;
* Measure the ACE2 levels.

Patients with oncological pathology who contracted COVID 19 infection from January 1, 2020 until the WHO declaration of the end of the pandemic will be studied.

Conditions

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Covid19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Cancer patients

* confirmation of COVID-19 in the laboratory (RT-PCR techniques);
* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever\> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
* asymptomatic cases; diagnosed based on positive swab results but without symptoms

No intervention on patients

Intervention Type OTHER

No intervention on patients

Interventions

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No intervention on patients

No intervention on patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* confirmation of COVID-19 in the laboratory (RT-PCR techniques);
* suspected cases of COVID-19; clinically diagnosed based on symptoms (fever\> 37.5 °, decrease in oximeter saturation by at least 5%, cough, diarrhea, otitis, dysgeusia, myalgia, arthralgia, conjunctivitis and rhinorrhea) + close contact a COVID-19 subject positive;
* asymptomatic cases; diagnosed based on positive swab results but without symptoms even dead patients

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Andrea Tortora di Pagani

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Di Lorenzo

Role: PRINCIPAL_INVESTIGATOR

Oncology Unit

Locations

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Oncology Unit, Hospital Andrea Tortora

Pagani, Salerno, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Data Manager Oncology Unit

Role: CONTACT

+390819213683

Facility Contacts

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Data Manager Oncology Unit

Role: primary

+390819213683

Data Manager Oncology Unit

Role: backup

+390819213658

Other Identifiers

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COICA_PAG_01

Identifier Type: -

Identifier Source: org_study_id

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