RecruitingNCT06717295

The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling

Sponsor

Javier Toledo

Enrollment

6,000 participants

Start Date

Dec 20, 2025

Study Type

OBSERVATIONAL

Conditions

Ovarian Cancer Brest Cancer Prostate Cancers Lung Cancer (NSCLC)Pancreatic Cancer, Adult

Summary

The purpose of the CCANED-CIPHER study is to develop and validate an AI-based blood test for early cancer detection and to monitor treatment effectiveness in cancer patients. This two-phase, multi-center observational study aims to identify specific transcriptomic biomarkers in platelets and immune cells that distinguish cancer patients from healthy individuals and correlate with treatment outcomes. By analysing blood samples using artificial intelligence, the study seeks to create a safe, non-invasive method to enhance cancer diagnosis and monitor treatment responses over time.

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria6

Phase 1 (Common Cancer Early Detection - CCANED)
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.
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 Criteria7

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)
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.

Interventions

DIAGNOSTIC_TESTDiNanoQ: A multi-cancer early detection (MCED) blood test

Procedure: Participants will undergo a single blood draw at baseline. Sample Analysis: Platelet Isolation: Platelets will be extracted from the collected blood samples. RNA Analysis: RNA from the isolated platelets will be extracted and analyzed using AI-based transcriptomic profiling to identify biomarkers associated with cancer.

OTHERDiNanoTrack: Therapeutic Response Monitoring Blood Test

Procedures: Blood Sample Collection: Participants will have blood samples drawn at three time points: Baseline: Before therapy initiation. 6 Weeks Post-Therapy Initiation: To monitor early treatment response. 6 Months Post-Therapy Initiation: To assess longer-term therapeutic outcomes. Sample Analysis: Platelet and Immune Cell Isolation: Platelets: Extracted from each blood sample to continue monitoring RNA profiles. Immune Cells: Separated from the blood samples to analyse immune response to therapy. RNA Analysis: Platelet RNA: Analysed to observe changes in transcriptomic profiles over time using AI-based tools. Immune Cell RNA: Examined to assess transcriptomic changes associated with therapeutic responses. Data Correlation: Therapeutic Response Assessment: RNA profiles from platelets and immune cells will be correlated with clinical outcomes to identify biomarkers predictive of treatment efficacy, progression-free survival, relapse, and drug resistance.