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

NCT04119154 | Completed

• 2 other identifiers: BHP0111UH3CA202637
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms; Lymphoma

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma

  Day 1, at time of diagnosis

• Accuracy for molecular subtype diagnosis of invasive breast cancer

  Day 1, at time of diagnosis

Study Arms (1)

Standard diagnosis and CEM platform

EXPERIMENTAL

Participants will receive standard diagnostic approach and assessment by CEM platform

Diagnostic Test: Contrast Microhalography (CEM)

Interventions

Contrast Microhalography (CEM) DIAGNOSTIC_TEST

Fine needle aspirates evaluated by CEM device

Standard diagnosis and CEM platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• National Cancer Institute (NCI): collaborator
• Botswana Harvard AIDS Institute Partnership: collaborator
• Massachusetts General Hospital: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Botswana Harvard AIDS Institute

Gaborone, Botswana

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking, open label.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: August 1, 2019
• Primary Completion: September 20, 2021
• Study Completion: September 20, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Following completion of primary analysis.
• Access Criteria: Sharing following required IRB approval (Botswana and US).

Locations

BO (1)