AI blood test using platelet and immune-cell RNA for early cancer detection and monitoring
The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
Dysplasia Diagnostics Limited · NCT06717295
This AI-based blood test profiles platelet and immune-cell RNA to see if it can find common cancers early and track treatment response in adults aged 40 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Dysplasia Diagnostics Limited (industry) |
| Locations | 4 sites (Rosario and 3 other locations) |
| Trial ID | NCT06717295 on ClinicalTrials.gov |
What this trial studies
This observational, two-phase, multicenter project collects blood from adults with common cancers and matched cancer-free controls to profile platelet and immune-cell RNA. Phase 1 plans to enroll about 3,500 cancer patients and 1,500 controls and analyze a single baseline platelet RNA sample per participant to find diagnostic signatures. Phase 2 will collect longitudinal immune and extracellular RNA samples around therapy (baseline, ~6 weeks, ~6 months) to identify markers that change with treatment. Machine learning and AI models will be trained on RNA-sequencing data to identify biomarker patterns that distinguish cancer cases from controls and correlate with treatment outcomes.
Who should consider this trial
Good fit: Ideal participants are adults aged 40 or older with a confirmed diagnosis of one of the listed cancers (for example NSCLC, breast, prostate, ovarian, pancreatic, colorectal, HCC, or GBM) or matched cancer-free volunteers who can provide blood samples and meet the study's exclusion rules.
Not a fit: People who are pregnant, have active infections, have recently taken anticoagulant or antiplatelet drugs, cannot provide blood samples, or are under 40 are unlikely to be eligible or to receive direct benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a safe, non-invasive blood test to detect cancers earlier and to monitor how well treatments are working.
How similar studies have performed: Previous studies of tumor-educated platelets and AI analysis of cell-free DNA have shown promising early results, but large multicenter validation of platelet- and immune-cell RNA profiling for multi-cancer detection and treatment monitoring is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Phase 1 (Common Cancer Early Detection - CCANED) Inclusion Criteria: * Age: Adults aged 40 years or older. * Confirmed diagnosis of one of the following common cancers: Non-Small Cell Lung Cancer (NSCLC), Glioblastoma Multiforme (GBM), Colorectal Cancer, Hepatocellular Carcinoma (HCC), Breast Cancer, Prostate Cancer, Ovarian Cancer, Pancreatic Cancer. Exclusion Criteria: * Currently pregnant. * Presence of any active infectious diseases. * Use of anticoagulant or antiplatelet drugs within the past 2 weeks. * Any medical or psychological conditions that may affect the participant's ability to comply with study procedures. Phase 2 ( Cancer Immuno-Profiling of Hematologic and Extracellular RNA - CIPHER) Inclusion Criteria: * Adults aged 40 years or older. * Confirmed diagnosis of: Hepatocellular Carcinoma (HCC), Non-Small Cell Lung Cancer (NSCLC) * Willingness to provide blood samples at the specified intervals (baseline, 6 weeks, and 6 months post-therapy initiation). Exclusion Criteria: * Presence of another malignancy unless it has been in remission for at least 5 years. * Significant uncontrolled co-morbid conditions that may interfere with study participation or outcomes.
Where this trial is running
Rosario and 3 other locations
- Various Cancer Centres — Rosario, Argentina (ACTIVE_NOT_RECRUITING)
- NSIA- Lagos University Teaching Hospital Cancer Centre — Lagos, Nigeria (RECRUITING)
- Babraham Research Institute — Cambridge, United Kingdom (ENROLLING_BY_INVITATION)
- Dysplasia Diagnostics Limited — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Javier Toledo, Medical Degree — Dysplasia Diagnostics Limited
- Study coordinator: Javier Toledo, Medical Degree
- Email: research@dysplasiadx.com
- Phone: +44 (0)1223 496000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brest Cancer, Lung Cancer, Pancreatic Cancer, Adult, Prostate Cancers, Ovarian Cancer, Colorectal Cancer, Glioblastoma, Liver Carcinoma