Prospective Determination of COVID-19 Infection Rate in a Chemotherapy Unit in Mexico.
23 de fevereiro de 2022 atualizado por: David Huitzil m, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Prospective Determination of COVID-19 Infection Rate in Patients With Solid Tumors and Healthcare Workers of the Chemotherapy and Radiotherapy Unit at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador.
Cancer patients are considered vulnerable to COVID-19 infection.
During the pandemic, cancer patients may need to continue their regular treatment of chemotherapy and / or radiotherapy and therefore must visit a hospital unit.
As such, they may be at risk for SARS-CoV-2 infection by means of close contact to other patients and health care workers.
Hospitals may implement policies to identify symptomatic subjects and limit their access to the chemotherapy / radiotherapy unit.
However, asymptomatic COVID-19 positive patients may escape these filters and potentially be contagious to other patients and their health-related workers that care for other several patients.
Therefore, there is a real risk of an outbreak that affects a particularly fragile patient population.
Patients and their doctors need to know what is the risk associated to visiting a chemotherapy unit in order to decide if the risk outweighs the benefits of cancer treatment in their particular case.
To date, this risk is unknown.
The study will test patients and health care workers for COVID-19 infection during the peak of the pandemic in a chemotherapy unit in Mexico in order to determine this risk.
Visão geral do estudo
Descrição detalhada
In this is prospective cohort, patients with solid tumors and healthcare workers of the chemotherapy and radiotherapy unit at our center will be followed with a daily digital survey and optionally with biweekly PCR tests for SARS-CoV-2. People with symptoms and / or with a positive PCR test for SARS-CoV-2 will be notified and recommendations according to clinical state will be emitted.
Hypothesis: COVID-19 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy will be less than 5% during the pandemic period.
Tipo de estudo
Observacional
Inscrição (Real)
149
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Mexico City, México, 14080
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with cancer and solid tumors receiving treatment at the chemotherapy and radiotherapy unit, and health-related workers treating these patients.
Descrição
Inclusion Criteria:
- Patients with solid tumors receiving active oncological treatment (chemotherapy, or radiotherapy or biologic therapy) at our center.
- Age: no limit
- Gender: men and women.
- Health-related worker treating patients with solid tumors at the chemotherapy and radiotherapy unit at our center.
- People who sign an informed consent.
Exclusion Criteria:
- Patients with an hematologic cancer.
- Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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Patients with solid tumors
Patients with solid tumors under chemotherapy and / or radiotherapy treatment at our center.
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Healthcare workers
Healthcare workers at the chemotherapy and radiotherapy unit in our center.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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SARS-CoV-2 infection rate in patients with solid tumors.
Prazo: From June 2020 to September 2020.
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Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period.
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From June 2020 to September 2020.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Integration of a cohort of patients with solid tumors receiving oncological treatment.
Prazo: 4 months
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Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent.
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4 months
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Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors.
Prazo: 4 months
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To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 among the cohort of patients with solid tumors through a daily digital survey.
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4 months
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SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms.
Prazo: 4 months
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To determine the SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms through a PCR test for SARS-CoV-2.
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4 months
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SARS-CoV-2 infection rate in asymptomatic patients with solid tumors.
Prazo: 4 months
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To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2.
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4 months
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Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 .
Prazo: 4 months
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Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2.
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4 months
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Integration of a cohort of healthcare workers.
Prazo: 4 months
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Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent.
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4 months
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Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers.
Prazo: 4 months
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To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey.
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4 months
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SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms.
Prazo: 4 months
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To determine the SARS-CoV-2 infection rate in the cohort of healthcare workers with respiratory symptoms through a PCR test for SARS-CoV-2.
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4 months
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SARS-CoV-2 infection rate in asymptomatic healthcare workers.
Prazo: 4 months
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To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2.
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4 months
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Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection.
Prazo: 4 months
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Determination of past infection rate in both cohorts (patients with solid tumors and health-related workers) through IgG antibodies detection at the beginning and at the end of the trial.
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4 months
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Register of oncological patients with solid tumors diagnosed with COVID-19.
Prazo: 4 months
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To create a register of oncological patients with solid tumors diagnosed with COVID-19.
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4 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available. Erratum In: JAMA. 2020 Apr 28;323(16):1619.
- Zhang L, Zhu F, Xie L, Wang C, Wang J, Chen R, Jia P, Guan HQ, Peng L, Chen Y, Peng P, Zhang P, Chu Q, Shen Q, Wang Y, Xu SY, Zhao JP, Zhou M. Clinical characteristics of COVID-19-infected cancer patients: a retrospective case study in three hospitals within Wuhan, China. Ann Oncol. 2020 Jul;31(7):894-901. doi: 10.1016/j.annonc.2020.03.296. Epub 2020 Mar 26.
- Yu J, Ouyang W, Chua MLK, Xie C. SARS-CoV-2 Transmission in Patients With Cancer at a Tertiary Care Hospital in Wuhan, China. JAMA Oncol. 2020 Jul 1;6(7):1108-1110. doi: 10.1001/jamaoncol.2020.0980.
- 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.
- Desai A, Sachdeva S, Parekh T, Desai R. COVID-19 and Cancer: Lessons From a Pooled Meta-Analysis. JCO Glob Oncol. 2020 Apr;6:557-559. doi: 10.1200/GO.20.00097. No abstract available.
- You B, Ravaud A, Canivet A, Ganem G, Giraud P, Guimbaud R, Kaluzinski L, Krakowski I, Mayeur D, Grellety T, Lotz JP. The official French guidelines to protect patients with cancer against SARS-CoV-2 infection. Lancet Oncol. 2020 May;21(5):619-621. doi: 10.1016/S1470-2045(20)30204-7. Epub 2020 Mar 25. No abstract available.
- Sidaway P. COVID-19 and cancer: what we know so far. Nat Rev Clin Oncol. 2020 Jun;17(6):336. doi: 10.1038/s41571-020-0366-2. No abstract available.
- Burki TK. Cancer guidelines during the COVID-19 pandemic. Lancet Oncol. 2020 May;21(5):629-630. doi: 10.1016/S1470-2045(20)30217-5. Epub 2020 Apr 2. No abstract available.
- Marijnen CAM, Peters FP, Rodel C, Bujko K, Haustermans K, Fokas E, Glynne-Jones R, Valentini V, Spindler KG, Guren MG, Maingon P, Calvo FA, Pares O, Glimelius B, Sebag-Montefiore D. International expert consensus statement regarding radiotherapy treatment options for rectal cancer during the COVID 19 pandemic. Radiother Oncol. 2020 Jul;148:213-215. doi: 10.1016/j.radonc.2020.03.039. Epub 2020 Apr 2. No abstract available.
- Verity R, Okell LC, Dorigatti I, Winskill P, Whittaker C, Imai N, Cuomo-Dannenburg G, Thompson H, Walker PGT, Fu H, Dighe A, Griffin JT, Baguelin M, Bhatia S, Boonyasiri A, Cori A, Cucunuba Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon D, Nedjati-Gilani G, Riley S, van Elsland S, Volz E, Wang H, Wang Y, Xi X, Donnelly CA, Ghani AC, Ferguson NM. Estimates of the severity of coronavirus disease 2019: a model-based analysis. Lancet Infect Dis. 2020 Jun;20(6):669-677. doi: 10.1016/S1473-3099(20)30243-7. Epub 2020 Mar 30. Erratum In: Lancet Infect Dis. 2020 Apr 15;: Lancet Infect Dis. 2020 May 4;:
- Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X, Zhu Q, Liu L. Profile of Immunoglobulin G and IgM Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020 Nov 19;71(16):2255-2258. doi: 10.1093/cid/ciaa489.
- Guo L, Ren L, Yang S, Xiao M, Chang D, Yang F, Dela Cruz CS, Wang Y, Wu C, Xiao Y, Zhang L, Han L, Dang S, Xu Y, Yang QW, Xu SY, Zhu HD, Xu YC, Jin Q, Sharma L, Wang L, Wang J. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Jul 28;71(15):778-785. doi: 10.1093/cid/ciaa310.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
11 de junho de 2020
Conclusão Primária (Real)
30 de setembro de 2020
Conclusão do estudo (Real)
30 de outubro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
25 de setembro de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de setembro de 2020
Primeira postagem (Real)
29 de setembro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de fevereiro de 2022
Última verificação
1 de fevereiro de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HEM-3412-20-20-1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Indeciso
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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