Clinical trial NCT04567979: Prospective Determination of COVID-19 Infection Rate in a Chemotherapy Unit in Mexico.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Cancer
Tumor
Keywords: Covid19
Cancer
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Instituto Nacional de Medicina Genomica
First posted: 2020-09-29
Enrollment: 149
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SARS-CoV-2 infection rate in patients with solid tumors.
timeFrame: From June 2020 to September 2020.
Secondary outcomes:
Other outcomes:
measure: Integration of a cohort of patients with solid tumors receiving oncological treatment.
timeFrame: 4 months
measure: Daily digital follow-up of new-onset respiratory symptoms in the cohort of patients with solid tumors.
timeFrame: 4 months
measure: SARS-CoV-2 infection rate in the cohort of patients with solid tumors and respiratory symptoms.
timeFrame: 4 months
measure: SARS-CoV-2 infection rate in asymptomatic patients with solid tumors.
timeFrame: 4 months
measure: Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 .
timeFrame: 4 months
measure: Integration of a cohort of healthcare workers.
timeFrame: 4 months
measure: Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers.
timeFrame: 4 months
measure: SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms.
timeFrame: 4 months
measure: SARS-CoV-2 infection rate in asymptomatic healthcare workers.
timeFrame: 4 months
measure: Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection.
timeFrame: 4 months
measure: Register of oncological patients with solid tumors diagnosed with COVID-19.
timeFrame: 4 months
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Fidel D Huitzil Meléndez, MD
role: PRINCIPAL_INVESTIGATOR
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