Breast NeoplasmsChedzaNCT04119154
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
A study testing Contrast Microhalography (CEM) in people with Breast Neoplasms and Lymphoma, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial summary
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Lymphoma
- What is being tested?
- Contrast Microhalography (CEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteBotswana
- Study dates
- 1 Aug 2019to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Read the detailed 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.
- Conditions
- Breast Neoplasms, Lymphoma
- Being tested
- Contrast Microhalography (CEM)
- Medical subject headings
- Breast Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Microhalography (CEM)Diagnostic test
Fine needle aspirates evaluated by CEM device
| Study group | Role | What they receive |
|---|---|---|
| Standard diagnosis and CEM platform | Experimental | Participants will receive standard diagnostic approach and assessment by CEM platform Receives: Diagnostic Test: Contrast Microhalography (CEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1, at time of diagnosis
Time to diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Measured: 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
Measured: Day 1, At completion of training
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1, at time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Aug 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Botswana Harvard AIDS Institute Partnership, Massachusetts General Hospital, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Scott Dryden-Peterson, Harvard School of Public Health (HSPH)
- Investigators
- Ralph Weissleder, MD, PhD, Principal investigator, Massachusetts General HospitalScott Dryden-Peterson, MD, MSc, Principal investigator, Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119154
- Sponsor's protocol ID
- BHP0111
- Other IDs
- UH3CA202637
- Acronym
- Chedza
- Status last verified
- Apr 2022
- First submitted
- 4 Oct 2019
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
- ClinicalTrials.gov ID
- NCT04119154
- Acronym / sponsor ID
- Chedza / BHP0111
- Conditions
- Breast Neoplasms, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Botswana Harvard AIDS Institute Partnership, Massachusetts General Hospital, Brigham and Women's Hospital
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cancer suspects will undergo standard diagnostic evaluation and novel diagnostic. Single arm.
| Arm | Type | Receives |
|---|---|---|
| Standard diagnosis and CEM platform | Experimental | Diagnostic Test: Contrast Microhalography (CEM)Participants will receive standard diagnostic approach and assessment by CEM platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Microhalography (CEM)Fine needle aspirates evaluated by CEM device | Diagnostic test | Standard diagnosis and CEM platform |
Primary outcome
Accuracy for diagnosis of non-Hodgkin lymphoma
Time frame: Day 1, at time of diagnosis
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Accuracy for diagnosis of invasive breast cancer
Time frame: Day 1, at time of diagnosis
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Time to diagnosis
Time frame: Day 1, at time of diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Proficiency in testing using CEM platform
Time frame: Day 1, At completion of training
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform
2 secondary outcomes
Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma
Time frame: Day 1, at time of diagnosis
Accuracy for molecular subtype diagnosis of invasive breast cancer
Time frame: Day 1, at time of diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: Yes. Completely anonymized data can be shared to investigators following successful receipt of IRB approval (Botswana and US committees).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Weissleder, MD, PhD principal investigator
Massachusetts General Hospital
Scott Dryden-Peterson, MD, MSc principal investigator
Botswana Harvard AIDS Institute, Harvard TH Chan School of Public Health, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Microhalography (CEM) in people with Breast Neoplasms and Lymphoma, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy for diagnosis of non-Hodgkin lymphoma (time frame: Day 1, at time of diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.