Clinical trial · Interventional
Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
NCT04119154CI-TRIAL-00058173ChedzacompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast Microhalography (CEM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Standard diagnosis and CEM platform
- description
- Participants will receive standard diagnostic approach and assessment by CEM platform
- interventionNames
- Diagnostic Test: Contrast Microhalography (CEM)
Primary outcomes (4)
- measure
- Accuracy for diagnosis of non-Hodgkin lymphoma
- timeFrame
- Day 1, at time of diagnosis
- description
- Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
- measure
- Accuracy for diagnosis of invasive breast cancer
- timeFrame
- Day 1, at time of diagnosis
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.