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

NCT06717295 | Recruiting DMC

• 1 other identifier: CCANED-CIPHER
• Study Type: observational
• Target: 6,000
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Brest Cancer; Lung Cancer (NSCLC); Pancreatic Cancer, Adult; Prostate Cancers; Ovarian Cancer; Colorectal Cancer; Glioblastoma (GBM); Liver Carcinoma

Keywords

cancer screening; Liquid Biopsy; AI-based Diagnostics; Early Cancer Detection; Circulating Tumor DNA (ctDNA); RNA Profiling; Biomarker; Precision Medicine; Oncology; Health Data Analysis; Platelets; treatment response; RNA; CircRNA; Splicing; Cancer

Outcome Measures

Primary Outcomes (3)

• Identification of Platelet RNA Biomarkers Distinguishing Cancer Patients from Controls

  Utilise AI-based transcriptomic analysis of platelet RNA to identify biomarkers that differentiate between cancer patients and cancer-free controls.

  Baseline (single time point)

• Identification of RNA Biomarkers Correlating with Therapeutic Response (Phase 2)

  Identify RNA biomarkers from immune cells and platelets that correlate with clinical treatment response, as measured by standard criteria (e.g., RECIST)

  Baseline to 6 months post-therapy initiation

• Association Between Immune Cell Transcriptomes and AI-Based Platelet Signals

  Evaluate how changes in immune cell transcriptomes are associated with signals detected by the AI-based platelet profiling tool.

  Baseline to 6 months post-therapy initiation

Secondary Outcomes (4)

• Sensitivity and Specificity of the AI-Based Diagnostic Tool (Phase 1)

  Baseline

• Feasibility of Platelet Transcriptomic Profiling Implementation

  Phase 1 - 2 years

• Development of Predictive Models for Treatment Outcomes (Phase 2)

  Phase 2 - Two years

• Identification of Biomarkers Predictive of Relapse and Drug Resistance (Phase 2)

  Baseline to 6 months post-therapy initiation

Study Arms (3)

Cancer Patients (Phase 1)

This arm will include 3,500 individuals with confirmed diagnoses of common cancers such as Non-Small Cell Lung Cancer (NSCLC), Glioblastoma Multiforme (GBM), Colorectal Cancer, Hepatocellular Carcinoma (HCC), Breast Cancer, Prostate Cancer, Ovarian Cancer, and Pancreatic Cancer.

Diagnostic Test: DiNanoQ: A multi-cancer early detection (MCED) blood test

Healthy Individuals

This arm will consist of 1,500 age- and sex-matched cancer-free individuals serving as controls.

Diagnostic Test: DiNanoQ: A multi-cancer early detection (MCED) blood test

Cancer Patients Undergoing Treatment

This cohort will include 1,000 patients diagnosed with Hepatocellular Carcinoma (HCC) or Non-Small Cell Lung Cancer (NSCLC) across stages I to IV who are about to commence standard cancer therapy.

Diagnostic Test: DiNanoQ: A multi-cancer early detection (MCED) blood test; Other: DiNanoTrack: Therapeutic Response Monitoring Blood Test

Interventions

DiNanoQ: A multi-cancer early detection (MCED) blood test DIAGNOSTIC_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.

Cancer Patients (Phase 1); Cancer Patients Undergoing Treatment; Healthy Individuals

DiNanoTrack: Therapeutic Response Monitoring Blood Test OTHER

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.

Cancer Patients Undergoing Treatment

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The CCANED-CIPHER study will enroll a diverse, geographically dispersed population to ensure the generalizability and robustness of its findings. The study is divided into two phases, utilizing up to 10 medical centers globally across the United Kingdom (UK), Europe, America, and Asia. Phase 1 (CCANED): Participants: 5,000 adults aged 40 years or older. * Cancer Patients: 3,500 individuals with confirmed diagnoses of common cancers. * Healthy Controls: 1,500 age-matched cancer-free individuals. Recruitment Strategy: Participants will be identified and enrolled through the participating medical centers, ensuring a representative sample across different geographical locations. Phase 2 (CIPHER): Participants: 1,000 adults aged 40 years or older diagnosed with HCC or NSCLC across stages I to IV. Recruitment Strategy: Cancer patients will be recruited from the participating cancer centers, ensuring a wide representation of disease stages and treatment backgrounds.

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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).
• 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.

Sponsors & Collaborators

• Javier Toledo: lead

Study Sites (4)

Various Cancer Centres

Rosario, Argentina

ACTIVE NOT RECRUITING

NSIA- Lagos University Teaching Hospital Cancer Centre

Lagos, Nigeria

RECRUITING

Babraham Research Institute

Cambridge, CB22 3AT, United Kingdom

ENROLLING BY INVITATION

Dysplasia Diagnostics Limited

London, W1W 7LT, United Kingdom

RECRUITING

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Related Links

• WHO report

Biospecimen

Retention: SAMPLES WITH DNA

The study will utilize various biological sources to profile RNA for cancer detection and treatment response. Blood samples will be collected from all participants, serving as the source for isolating platelets and immune cells for RNA analysis. Platelet isolates will be extracted from these blood samples. RNA from platelets will be analyzed to identify transcriptomic profiles that may serve as biomarkers for cancer detection and monitoring. Platelets can absorb RNA from tumor cells, reflecting the cancer's molecular signature. In Phase 2, immune cell isolates will be separated from the blood samples of cancer patients. RNA from these immune cells will be analysed to assess transcriptomic changes associated with therapeutic responses. Known driver mutations in immune cell DNA will be assessed for correlation with RNA alterations. This non-invasive approach will leverage liquid biopsy methods to enhance early cancer detection and personalise treatment monitoring.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic cancer, adult; Prostatic Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; Glioblastoma; Carcinoma, Hepatocellular; Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Liver Neoplasms; Liver Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Solomon Rotimi, PhD

  Dysplasia Diagnostics Limited

  STUDY DIRECTOR

• Javier Toledo, Medical Degree

  Dysplasia Diagnostics Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Toledo, Medical Degree

CONTACT

+44 (0)1223 496000; research@dysplasiadx.com

Osagie Izuogu, PhD

CONTACT

+44 (0)1223 496000; info@dysplasiadx.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 5, 2024
• Study Start: December 20, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

GB (2); NG (1); AR (1)