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

Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04567979
• Other study ID #: HEM-3412-20-20-1
• Status: Completed
• Start date: June 11, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: February 2022
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• COVID-19
• Covid19
• Tumor

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Instituto Nacional de Medicina Genomica

Country where clinical trial is conducted

Mexico, 

References & Publications (12)

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. — View Citation

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. — View Citation

Guo L, Ren L, Yang S, Xiao M, Chang, 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 — View Citation

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. — View Citation

Marijnen CAM, Peters FP, Rödel 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 — View Citation

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. Erratum in: JAMA. 2020 Apr 28;323(16):1619. — View Citation

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. — View Citation

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. — View Citation

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, Cucunubá Z, FitzJohn R, Gaythorpe K, Green W, Hamlet A, Hinsley W, Laydon — View Citation

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 — View Citation

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. — View Citation

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 wit — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Integration of a cohort of patients with solid tumors receiving oncological treatment.	Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent.	4 months
Other	Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors.	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.	4 months
Other	SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms.	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.	4 months
Other	SARS-CoV-2 infection rate in asymptomatic patients with solid tumors.	To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2.	4 months
Other	Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 .	Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2.	4 months
Other	Integration of a cohort of healthcare workers.	Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent.	4 months
Other	Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers.	To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey.	4 months
Other	SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms.	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.	4 months
Other	SARS-CoV-2 infection rate in asymptomatic healthcare workers.	To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2.	4 months
Other	Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection.	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.	4 months
Other	Register of oncological patients with solid tumors diagnosed with COVID-19.	To create a register of oncological patients with solid tumors diagnosed with COVID-19.	4 months
Primary	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.

External Links

•   ASCO official guidelines for SARS-CoV-2 among cancer patients
•   ESMO official guidelines for SARS-CoV-2 among cancer patients
•   World Health Organization. Director-General's remarks at the media briefing on 2019-nCoV.