A Study to Determine the Effects of COVID-19 in Cancer Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-007210
- Mankato, Minnesota: 20-007210
- La Crosse, Wisconsin: 20-007210
- Eau Claire, Wisconsin: 20-007210
- Scottsdale/Phoenix, Arizona: 20-007210
NCT ID: NCT04387656
Sponsor Protocol Number: NCICOVID
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:
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. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Mankato, Minn.
Mayo Clinic principal investigator Mohamad Sonbol, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
La Crosse, Wis.
Mayo Clinic principal investigator Mohamad Sonbol, M.D. |
Closed 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. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
855-776-0015
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Mohamad Sonbol, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available