Skip to main content
OpenTrials
Completed

NCT Number: NCT04567979

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Cancer Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasms Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tumor Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: From June 2020 to September 2020.

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

Other outcomes

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

    Time frame: 4 months

    Identification of patients with solid tumors receiving chemotherapy and / or radiotherapy in our center during the COVID-19 pandemic to get informed consent.

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

    Time frame: 4 months

    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.

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

    Time frame: 4 months

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

    Time frame: 4 months

    To determine the SARS-CoV-2 infection rate in asymptomatic patients with solid tumors through a biweekly PCR test for SARS-CoV-2.

  5. Determination of clinical features and outcomes of cancer patients infected with SARS-CoV-2 .

    Time frame: 4 months

    Determination of demographics, clinical and outcomes of cancer patients infected with SARS-CoV-2.

  6. Integration of a cohort of healthcare workers.

    Time frame: 4 months

    Identification of healthcare workers that treat patients with solid tumors in the chemotherapy and radiotherapy unit at our center to get informed consent.

  7. Daily digital follow-up of new-onset respiratory symptoms in the cohort of healthcare workers.

    Time frame: 4 months

    To determine the rate of new-onset respiratory symptoms suggestive of COVID-19 between the cohort of healthcare workers through a daily digital survey.

  8. SARS-CoV-2 infection rate in the cohort of health-related workers and respiratory symptoms.

    Time frame: 4 months

    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.

  9. SARS-CoV-2 infection rate in asymptomatic healthcare workers.

    Time frame: 4 months

    To determine the SARS-CoV-2 infection rate in asymptomatic healthcare workers through a biweekly PCR test for SARS-CoV-2.

  10. Determination of past infection rate in asymtomatic people through SARS-CoV-2 IgG antibodies detection.

    Time frame: 4 months

    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.

  11. Register of oncological patients with solid tumors diagnosed with COVID-19.

    Time frame: 4 months

    To create a register of oncological patients with solid tumors diagnosed with COVID-19.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Other

Collaborators

  • Instituto Nacional de Medicina Genomica

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2020
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.