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

NCT ID: NCT04567979

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-11

Study Completion Date

2020-10-30

Brief Summary

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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

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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.

Conditions

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Covid19 Cancer Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with solid tumors

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

No interventions assigned to this group

Healthcare workers

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

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Medicina Genomica

OTHER_GOV

Sponsor Role collaborator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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David Huitzil m

Médico Especialista A

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fidel D Huitzil Meléndez, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type RESULT
PMID: 32203977 (View on PubMed)

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.

Reference Type RESULT
PMID: 32224151 (View on PubMed)

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.

Reference Type RESULT
PMID: 32211820 (View on PubMed)

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.

Reference Type RESULT
PMID: 32066541 (View on PubMed)

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.

Reference Type RESULT
PMID: 32250659 (View on PubMed)

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.

Reference Type RESULT
PMID: 32220659 (View on PubMed)

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.

Reference Type RESULT
PMID: 32265531 (View on PubMed)

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.

Reference Type RESULT
PMID: 32247319 (View on PubMed)

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.

Reference Type RESULT
PMID: 32342861 (View on PubMed)

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.

Reference Type RESULT
PMID: 32240634 (View on PubMed)

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.

Reference Type RESULT
PMID: 32337590 (View on PubMed)

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.

Reference Type RESULT
PMID: 32198501 (View on PubMed)

Related Links

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http://www.who.int/dg/speeches/detail/who-director-general-s-remarks-at-the-media-briefing-on-2019-ncov-on-11-february-2020

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

Other Identifiers

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HEM-3412-20-20-1

Identifier Type: -

Identifier Source: org_study_id

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