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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-03470 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0318 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| William Marsh Rice University | OTHER |
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This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
PRIMARY OBJECTIVE:
I. To evaluate the clinical performance of a novel point-of-care diagnostic test for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes the disease called coronavirus disease 19 (COVID-19).
SECONDARY OBJECTIVES:
I. To compare the clinical performance of provider-collected nasopharyngeal samples with self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2 diagnostic test.
II. To measure viral load and evaluate the role of viral load in COVID-19 severity.
OUTLINE:
Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
After completion of study, participants are followed up at 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (biospecimen collection) | Experimental | Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of nasopharyngeal, oral, saliva, and nasal samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of diagnostic test | Will use the standard-of-care (real time polymerase chain reaction [RT-PCR]) coronavirus disease 19 (COVID-19) test at the MD Anderson Molecular Diagnostic Lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the true result to estimate sensitivity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab. | Up to 1 year |
| Specificity of diagnostic test | Will use the standard-of-care (RT-PCR) COVID-19 test at the MD Anderson Molecular Diagnostic Lab result for SARS-CoV-2 as the true result to estimate specificity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab. | Up to 1 year |
| Concordance of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year |
| Positive predictive value (PPV) of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year |
| Negative predictive value (NPV) of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load metrics | Will use descriptive statistics to summarize viral load metrics from the standard-of-care (RT-PCR) SARS-CoV-2 test and from each of the point-of-care tests. | Up to 1 month |
| Disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Schmeler | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyndon Baines Johnson General Hospital | Houston | Texas | 77026-1967 | United States | ||
| M D Anderson Cancer Center |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2022 | |
| Reset | May 20, 2022 | |
| Release | Sep 18, 2023 | |
| Reset | Oct 10, 2023 | |
| Release | Apr 1, 2026 | |
| Reset | Apr 24, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2022 | May 20, 2022 | |||
| Sep 18, 2023 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Questionnaire Administration | Other | Demographic information, sample collection type preferences; clinical outcome information |
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Will use logistic regression methods to model progression to severe disease (defined as hospitalization) as a function of viral load, age, gender, smoking history, comorbidities, and symptoms for each of these tests.
| Up to 1 month |
| Houston |
| Texas |
| 77030 |
| United States |
| Oct 10, 2023 |
| Apr 1, 2026 | Apr 24, 2026 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |