COVID-19 Infection in Cancer Pantients

• Conditions: Covid19
• Interventions: Other: No intervention on patients

• Registration Number: NCT04569292
• Lead Sponsor: Ospedale Andrea Tortora di Pagani

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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-28
• Last Update Submitted: 2020-09-28
• Study First Posted: 2020-09-29
• Last Update Posted: 2020-09-29
• Primary Completion: 2021-04
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients	No intervention on 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

Primary Outcome Measures

Name	Time	Method
describe cancer patients with COVID-19 and their clinical course	Almost 1 year	Describing cancer patients with COVID-19 and their clinical course will help us to identify predictors of the most severe clinical course and also prognostic factors

Trial Locations

Locations (1)

Oncology Unit, Hospital Andrea Tortora; 🇮🇹 Pagani, Salerno, Italy