Prospective Determination of COVID-19 Infection Rate in a Chemotherapy Unit in Mexico.

NCT04567979 | Completed

• 1 other identifier: HEM-3412-20-20-1
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19; Cancer; Tumor

Keywords

Covid19; Cancer

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 infection rate in patients with solid tumors.

  Determination of SARS-CoV-2 infection rate among patients with solid tumors treated with chemotherapy and / or radiotherapy during the pandemic period.

  From June 2020 to September 2020.

Other Outcomes (11)

• Integration of a cohort of patients with solid tumors receiving oncological treatment.

  4 months

• Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors.

  4 months

• SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms.

  4 months

Study Arms (2)

Patients with solid tumors

Patients with solid tumors under chemotherapy and / or radiotherapy treatment at our center.

Healthcare workers

Healthcare workers at the chemotherapy and radiotherapy unit in our center.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer and solid tumors receiving treatment at the chemotherapy and radiotherapy unit, and health-related workers treating these patients.

You may qualify if:

• 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.

You may not qualify if:

• Patients with an hematologic cancer.
• Patients with cancer under surveillance or without active oncological treatment, or receiving treatment in another center.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Instituto Nacional de Medicina Genomica: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Related Publications (12)

• 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.

  PMID: 32203977 RESULT

• 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.

  PMID: 32224151 RESULT

• 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.

  PMID: 32211820 RESULT

• 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.

  PMID: 32066541 RESULT

• 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.

  PMID: 32250659 RESULT

• 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.

  PMID: 32220659 RESULT

• 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.

  PMID: 32265531 RESULT

• 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.

  PMID: 32247319 RESULT

• 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.

  PMID: 32342861 RESULT

• 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.

  PMID: 32240634 RESULT

• 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.

  PMID: 32337590 RESULT

• 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.

  PMID: 32198501 RESULT

Related Links

• World Health Organization. Director-General's remarks at the media briefing on 2019-nCoV.

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and serum.

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Fidel D Huitzil Meléndez, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médico Especialista A

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 29, 2020
• Study Start: June 11, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

ME (1)