Clinical trial NCT04569292: COVID-19 Infection in Cancer Pantients
Official title: Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: COVID-19
Oncological patients
Cancer
Coronavirus infection disease
Lead sponsor: Ospedale Andrea Tortora di Pagani
Sponsor class: NETWORK
First posted: 2020-09-29
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: describe cancer patients with COVID-19 and their clinical course
timeFrame: Almost 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pagani
country: Italy
facility: Oncology Unit, Hospital Andrea Tortora
state: Salerno
Study officials:
affiliation: Oncology Unit
name: Giuseppe Di Lorenzo
role: PRINCIPAL_INVESTIGATOR
References: