Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Lymphoma Clinical Trial

— Chedza  

Official title:

Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119154
• Other study ID #: BHP0111
• Secondary ID: UH3CA202637
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2022
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Botswana citizen

• Age 18 years or older

• Able and willing to provide informed consent

• Undergoing diagnostic procedure for palpable abnormality (biopsy, node/mass resection, or fine-needle aspirate) for diagnosis of possible lymphoid malignancy or breast cancer

Exclusion Criteria:

• Involuntary incarceration (prison, jail, etc.)

• Procedures involving internal organs or locations expected to have elevated risk of complication

• Increased risk for severe bleeding as defined as known hemophilia or other bleeding disorder, use of anticoagulants in past week (not including aspirin or other NSAIDS), advanced liver disease, or other condition determined by clinician to significantly increase bleeding risk of procedure

• Known pregnancy

• Critical illness as defined by current intensive care admission, hypotension (systolic BP<100mmHg), hypoxemia (O2 saturation <94% on room air), or other condition determined by clinician to significantly decrease physiologic tolerance of procedure

• Other condition felt by the clinician performing procedure to significantly increase risk of procedure

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphoma

Intervention

Diagnostic Test:
• Contrast Microhalography (CEM)
Fine needle aspirates evaluated by CEM device

Locations

Country	Name	City	State
Botswana	Botswana Harvard AIDS Institute	Gaborone

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Botswana Harvard AIDS Institute Partnership, Brigham and Women's Hospital, Massachusetts General Hospital, National Cancer Institute (NCI)

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Time to diagnosis	Time from diagnostic procedure to knowledge of test result by the treating clinician	Day 1, at time of diagnosis
Primary	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
Secondary	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
Secondary	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.	Day 1, at time of diagnosis