COVID-19 Infection in Cancer Pantients (COICA)

September 28, 2020 updated by: Ospedale Andrea Tortora di Pagani

Clinical Course of Cancer Patients Who Contracted COVID 19 Infection: An Observational Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
No intervention on patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
describe cancer patients with COVID-19 and their clinical course
Time Frame: 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
Almost 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Andrea Tortora di Pagani

Investigators

  • Principal Investigator: Giuseppe Di Lorenzo, Oncology Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COICA_PAG_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on No intervention on patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe