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| ID | Type | Description | Link |
|---|---|---|---|
| UH3CA202637 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Botswana Harvard AIDS Institute Partnership | OTHER |
| Massachusetts General Hospital | OTHER |
| Brigham and Women's Hospital |
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Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard diagnosis and CEM platform | Experimental | Participants will receive standard diagnostic approach and assessment by CEM platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Microhalography (CEM) | Diagnostic Test | Fine needle aspirates evaluated by CEM device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy for diagnosis of non-Hodgkin lymphoma | Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach. | Day 1, at time of diagnosis |
| Accuracy for diagnosis of invasive breast cancer | Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach. | Day 1, at time of diagnosis |
| Time to diagnosis | Time from diagnostic procedure to knowledge of test result by the treating clinician | Day 1, at time of diagnosis |
| Proficiency in testing using CEM platform | Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform | Day 1, At completion of training |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma | Accuracy (proportion of true positive and true negative out of total number non-Hodgkin lymphoma) of CEM in comparison with standard diagnostic approach. | Day 1, at time of diagnosis |
| Accuracy for molecular subtype diagnosis of invasive breast cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Weissleder, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Scott Dryden-Peterson, MD, MSc | Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Botswana Harvard AIDS Institute | Gaborone | Botswana |
Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
Following completion of primary analysis.
Sharing following required IRB approval (Botswana and US).
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2019 | Apr 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| OTHER |
Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
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No masking, open label.
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Accuracy (proportion of true positive and true negative out of total number of invasive breast cancers), compared with standard diagnostic approach, for the molecular subtype diagnosis of invasive breast cancer into estrogen-receptor positive, triple-negative, and other estrogen-receptor negative categories. |
| Day 1, at time of diagnosis |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |