CClinicalTrials.gg
Sign In
Status unknownNCT04434261ASTANAUpdated Mar 8, 2021

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

An observational study in SARS-CoV-2, Oncology and Surgery, sponsored by Instituto Brasileiro de Controle do Cancer. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by Instituto Brasileiro de Controle do Cancer · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • SARS-CoV-2
  • Oncology
  • Surgery

Browse trials for

Keywords

  • SARS-CoV-2
  • Surgical Oncology
  • PT-PCR Screening Test
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Instituto Brasileiro de Controle do Cancer is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Urgent or emergency surgery;
  • Screening test for SARS-COV-2 not performed
  • Incomplete data in the institutional database
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testPT-PCR test for SARS-CoV-2

    Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients

06

What researchers measure

Primary outcomes

  1. Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program

    Describe the incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program in our center

    Time frame: May- December 2020

Secondary outcomes

  1. Incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test;

    Describe the incidence of SARS-CoV-2 infection in the postoperative period in patients with negative screening test.

    Time frame: Up to 30 days

  2. Postoperative complications

    Postoperative complications will be recorded, according to the Clavien-Dindo classification.

    Time frame: Up to 30 days

  3. Mortality

    To evaluate the risk of all-cause mortality

    Time frame: 30 days

  4. Delay in the cancer treatment

    Assess the impact of delayed cancer treatment

    Time frame: May 2020- March 2021

07

Study locations

1 of 1 sites recruiting
  • Instituto Brasileiro de Controle do Cancer - IBCC
    Sao Paulo, Brazil
    Recruiting
08

References and documents

Publications

  • Shinde RS, Naik MD, Shinde SR, Bhandare MS, Chaudhari VA, Shrikhande SV, Dcruz AK. To Do or Not to Do?-A Review of Cancer Surgery Triage Guidelines in COVID-19 Pandemic. Indian J Surg Oncol. 2020 Jun;11(2):175-181. doi: 10.1007/s13193-020-01086-7. Epub 2020 May 11. PubMed 32395064 ↗
  • Liang W, Guan W, Chen R, Wang W, Li J, Xu K, Li C, Ai Q, Lu W, Liang H, Li S, He J. Cancer patients in SARS-CoV-2 infection: a nationwide analysis in China. Lancet Oncol. 2020 Mar;21(3):335-337. doi: 10.1016/S1470-2045(20)30096-6. Epub 2020 Feb 14. No abstract available. PubMed 32066541 ↗
  • Romanzi A, Galletti M, Macchi L, Putorti A, Rossi F, Scolaro R, Vannelli A. Awake laparotomy: is locoregional anesthesia a functional option for major abdominal surgeries in the COVID-19 era? Eur Rev Med Pharmacol Sci. 2020 May;24(9):5162-5166. doi: 10.26355/eurrev_202005_21211. PubMed 32432781 ↗
  • Wang H, Zhang L. Risk of COVID-19 for patients with cancer. Lancet Oncol. 2020 Apr;21(4):e181. doi: 10.1016/S1470-2045(20)30149-2. Epub 2020 Mar 3. No abstract available. PubMed 32142621 ↗
  • Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30. PubMed 32007143 ↗
  • Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113. doi: 10.1001/jama.2021.2336. PubMed 32031570 ↗
  • Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28. PubMed 32345594 ↗
  • Tan KK, Moran BJ, Solomon MJ. Avoiding collateral mortality in a pandemic - time to change our mindset in surgical oncology. Nat Rev Clin Oncol. 2020 Jul;17(7):383-385. doi: 10.1038/s41571-020-0383-1. PubMed 32372035 ↗
  • Tuech JJ, Gangloff A, Di Fiore F, Michel P, Brigand C, Slim K, Pocard M, Schwarz L. Strategy for the practice of digestive and oncological surgery during the Covid-19 epidemic. J Visc Surg. 2020 Jun;157(3S1):S7-S12. doi: 10.1016/j.jviscsurg.2020.03.008. Epub 2020 Mar 31. PubMed 32249098 ↗
  • Schrag D, Hershman DL, Basch E. Oncology Practice During the COVID-19 Pandemic. JAMA. 2020 May 26;323(20):2005-2006. doi: 10.1001/jama.2020.6236. No abstract available. PubMed 32282023 ↗
  • Bourget-Murray J, Heard BJ, Bansal R, Johnson AS, Powell J. Postoperative fever in the time of COVID-19. Can J Surg. 2020 May 8;63(3):E231-E232. doi: 10.1503/cjs.004720. PubMed 32386473 ↗
  • Bartlett DL, Howe JR, Chang G, Crago A, Hogg M, Karakousis G, Levine E, Maker A, Mamounas E, McGuire K, Merchant N, Shibata D, Sohn V, Solorzano C, Turaga K, White R, Yang A, Yoon S; Society of Surgical Oncology. Management of Cancer Surgery Cases During the COVID-19 Pandemic: Considerations. Ann Surg Oncol. 2020 Jun;27(6):1717-1720. doi: 10.1245/s10434-020-08461-2. Epub 2020 Apr 8. No abstract available. PubMed 32270420 ↗
  • Tilmans G, Chenevas-Paule Q, Muller X, Breton A, Mohkam K, Ducerf C, Mabrut JY, Lesurtel M. Surgical outcomes after systematic preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening. Surgery. 2020 Aug;168(2):209-211. doi: 10.1016/j.surg.2020.05.006. Epub 2020 May 18. No abstract available. PubMed 32425247 ↗
  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PubMed 15273542 ↗
  • COVIDSurg Collaborative. Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study. Lancet. 2020 Jul 4;396(10243):27-38. doi: 10.1016/S0140-6736(20)31182-X. Epub 2020 May 29. Erratum In: Lancet. 2020 Jul 25;396(10246):238. doi: 10.1016/S0140-6736(20)31350-7. PubMed 32479829 ↗
  • Peak CM, Kahn R, Grad YH, Childs LM, Li R, Lipsitch M, Buckee CO. Individual quarantine versus active monitoring of contacts for the mitigation of COVID-19: a modelling study. Lancet Infect Dis. 2020 Sep;20(9):1025-1033. doi: 10.1016/S1473-3099(20)30361-3. Epub 2020 May 20. PubMed 32445710 ↗
  • Ganesh Kumar N, Drolet BC. COVID-19 - Implications on and of Surgical Practices: Where Do We Draw the Line? Ann Surg. 2020 Aug;272(2):e45-e46. doi: 10.1097/SLA.0000000000004009. No abstract available. PubMed 32675491 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04434261
Lead sponsor
Instituto Brasileiro de Controle do Cancer
Responsible party
Sponsor
First posted
Jun 16, 2020
Start date
May 11, 2020
Primary completion
Dec 31, 2020
Completion
Sep 30, 2021 (estimated)
Last update
Mar 8, 2021

Study contacts

Andre Lopes, MD
Contact
andrelopes1002@hotmail.com
+551134744242
Alayne Yamada, PhD
Contact
alayne.pesquisa@ibcc-mooca.org.br
+551134744242
Andre Lopes, MD
principal investigator · Instituto Brasileiro de Controle do Cancer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

Instituto Brasileiro de Controle do Cancer

Start the discussion