Clinical trial · Observational
EXoPERT EMERALD Clinical Study
EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol
- 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)
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.
Conditions
Conditions (5)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXoPred | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Control
- interventionNames
- Diagnostic Test: EXoPred
- label
- Lung Cancer
- interventionNames
- Diagnostic Test: EXoPred
- label
- Breast Cancer
- interventionNames
- Diagnostic Test: EXoPred
- label
- Colorectal Cancer
- interventionNames
- Diagnostic Test: EXoPred
- label
- Pancreatic Cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer. * Subjects who are willing and able to provide written informed consent. * Subjects who are willing and able to comply with the study requirements. Exclusion Criteria: * Any history of cancer diagnosed and treated within 5 years prior to the date of consent. * Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis. * Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant. * Subjects who are pregnant or breastfeeding women. * Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months. * Subjects who are currently in active treatment for drug abuse. * Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study. * Unsuitable sample for testing due to contamination, hemolysis, etc.
References
Publications (0)
Data not yet available