Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2 (ASTANA)

March 4, 2021 updated by: Instituto Brasileiro de Controle do Cancer
To evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cohort, prospective, observational study to evaluate the incidence of asymptomatic patients with a positive SARS-CoV-2 test detected in the preoperative screening program of the institution.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Recruiting
        • Instituto Brasileiro De Controle Do Câncer - IBCC
        • Contact:
        • Principal Investigator:
          • Andre Lopes, MD

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with scheduled elective surgery, including all types of cancer

Description

Inclusion Criteria:

  • Patients with elective surgery scheduled at the IBCC, including those diagnosed with any type of cancer;
  • Patients who will undergo the screening test for SARS-COV-2 by RT-PCR (nasal swab), according to the guidelines and protocol of the hospital

Exclusion Criteria:

  • Urgent or emergency surgery;
  • Screening test for SARS-COV-2 not performed
  • Incomplete data in the institutional database

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
Patients tested for SARS-CoV-2
Patients who underwent the preoperative screening program for SARS-CoV-2
Diagnostic test: PT-PCR test for SARS-CoV-2
Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program
Time Frame: May- December 2020
Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center
May- December 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;
Time Frame: Up to 30 days
Describe the incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test.
Up to 30 days
Postoperative complications
Time Frame: Up to 30 days
Postoperative complications will be recorded, according to the Clavien-Dindo classification.
Up to 30 days
Mortality
Time Frame: 30 days
To evaluate the risk of all-cause mortality
30 days
Delay in the cancer treatment
Time Frame: May 2020- March 2021
Assess the impact of delayed cancer treatment
May 2020- March 2021

Collaborators and Investigators

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

Sponsor

Instituto Brasileiro de Controle do Cancer

Investigators

  • Principal Investigator: Andre Lopes, MD, Instituto Brasileiro de Controle Do Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 11, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (ACTUAL)

June 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33467320.0.0000.0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

The data will become available in a scientific publication

IPD Sharing Access Criteria

There are no sharing Access Criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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 Surgery

Clinical Trials on PT-PCR test for SARS-CoV-2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe