An interventional study of Contrast Microhalography (CEM) in Breast Neoplasms and Lymphoma, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in Botswana. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Diagnostic
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 270 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Participants will receive standard diagnostic approach and assessment by CEM platform
Diagnostic Test: Contrast Microhalography (CEM)
Fine needle aspirates evaluated by CEM device
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.
Time frame: 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.
Time frame: Day 1, at time of diagnosis
Time to diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Time frame: 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
Time frame: Day 1, At completion of training
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.
Time frame: Day 1, at time of diagnosis
Accuracy for molecular subtype diagnosis of invasive breast cancer
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.
Time frame: Day 1, at time of diagnosis
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Following completion of primary analysis.
Access criteria: Sharing following required IRB approval (Botswana and US).
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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