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SARS-CoV-2ASTANANCT04434261

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

An observational study of SARS-CoV-2 and Oncology, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
SARS-CoV-2, Oncology, Surgery
What is being tested?
PT-PCR test for SARS-CoV-2
How many people
1,500 participants
Where
1 siteBrazil
Study dates
11 May 2020to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Andre Lopes, MD contact

+551134744242

andrelopes1002@hotmail.com

Alayne Yamada, PhD contact

+551134744242

alayne.pesquisa@ibcc-mooca.org.br

Brazil1 site, 1 recruiting

  • Instituto Brasileiro de Controle do Cancer - IBCC

    São Paulo

    Alayne Yamada, PhD, +551134744242, alayne.pesquisa@ibcc-mooca.org.br

    Andre Lopes, MD

    Recruiting

Other trials in Brazil

About this study

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.

Being tested
PT-PCR test for SARS-CoV-2
Keywords
SARS-CoV-2, Surgical Oncology, PT-PCR Screening Test
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04434261
Study groupRoleWhat they receive
Patients tested for SARS-CoV-2Patients who underwent the preoperative screening program for SARS-CoV-2
Receives: Diagnostic Test: PT-PCR test for SARS-CoV-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: May- December 2020

Secondary outcomes (4)

  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.

    Measured: Up to 30 days

  2. Postoperative complications

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

    Measured: Up to 30 days

  3. Mortality

    To evaluate the risk of all-cause mortality

    Measured: 30 days

  4. Delay in the cancer treatment

    Assess the impact of delayed cancer treatment

    Measured: May 2020- March 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start11 May 2020
  3. Primary completion31 Dec 2020
  4. Study completion30 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04434261
Sponsor's protocol ID
33467320.0.0000.0072
Acronym
ASTANA
Status last verified
Mar 2021
First submitted
15 Jun 2020
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication

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.

    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.

    PubMed 32479829

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV-2 and Oncology, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andre Lopes, MD (+551134744242, andrelopes1002@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of patients with a positive test for SARS-CoV-2, detected in the preoperative screening program (time frame: May- December 2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04434261, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.

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