AI blood test using platelet and immune-cell RNA for early cancer detection and monitoring
Official title: The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
Run by Dysplasia Diagnostics Limited · NCT06717295 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | Dysplasia Diagnostics Limited Industry-sponsored |
| Locations | 4 sites (Rosario and 3 other locations) |
| Status | Recruiting |
| Started | December 20, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT06717295 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
NSIA- Lagos University Teaching Hospital Cancer Centre
Lagos, Nigeria Recruiting -
Dysplasia Diagnostics Limited
London, United Kingdom Recruiting -
Various Cancer Centres
Rosario, Argentina Active not recruiting -
Babraham Research Institute
Cambridge, United Kingdom Enrolling by invitation
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.