A Study to Determine the Effects of COVID-19 in Cancer Patients

Overview

About this study

The study aims to characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. The study also is aimed to describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. Lastely, evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Step 0 Eligibility Criteria

  • Age ≥ 18 years old
  • Patient must have a prior or current cancer diagnosis (e.g., solid tumor or hematologic malignancy) that fits into any one of the following categories:
    • Patient is receiving active treatment (defined as current treatment or treatment within the past 6 weeks) for metastatic cancer. Eligible treatment types are chemotherapy, immunotherapy, monoclonal antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy (e.g., BRAF/MEK inhibitor, EGFR inhibitor), endocrine therapy, or radiation therapy
    • Patients is receiving adjuvant treatment for non-metastatic (Stage I-III) cancer and has received intravenous chemotherapy, immunotherapy, targeted therapy, or radiation therapy within the past 6 weeks
    • Patient has received an allogenic stem cell transplant or CAR-T cell or other modified cellular therapy at any time
    • Patient is currently receiving treatment or prophylaxis for Graft vs. Host Disease
    • Patient has received an autologous bone marrow transplant within the past 2 years
  • Testing for SARS CoV-2
    • Patient must be undergoing or have undergone testing for SARS CoV-2.
    • Patients with prior negative SARS CoV-2 test(s) are eligible if they are being tested again. 
    • Patients with prior positive SARS CoV-2 test(s) more than 14 days prior to enrollment are not eligible.
  • HIV-infected patients are eligible
  • Patients with brain metastases are eligible
  • Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed.

Step 1 Eligibility Criteria

  • Positive SARS CoV-2 test within the 14 days prior to enrollment to Step 1
    • Patient must have a documented positive SARS CoV-2 test. The positive test results must have been received no earlier than 14 days prior to enrollment to Step 1.
    • The test must have been ordered by a doctor’s office, hospital, or department of public health.
    • Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is allowable for the SARS CoV-2 test.

Exclusion Criteria:

  • Patients < 18 years old.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola Arndt, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Mohammad Ranginwala, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Jonathan Ticku, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mohamad Sonbol, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20504261

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