COVID-19 Infection in Cancer Pantients

NCT04569292 | Unknown

• 1 other identifier: COICA_PAG_01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Keywords

COVID-19; Oncological patients; Cancer; Coronavirus infection disease

Outcome Measures

Primary Outcomes (1)

• describe cancer patients with COVID-19 and their clinical course

  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

  Almost 1 year

Study Arms (1)

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

Other: No intervention on patients

Interventions

No intervention on patients OTHER

No intervention on patients

Cancer patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Ospedale Andrea Tortora di Pagani: lead

Study Sites (1)

Oncology Unit, Hospital Andrea Tortora

Pagani, Salerno, 84016, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Giuseppe Di Lorenzo

  Oncology Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Data Manager Oncology Unit

CONTACT

+390819213683; trialclinici.oncopagani@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 29, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)