Clinical trial NCT06717295: The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
Official title: The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Dysplasia Diagnostics Limited
Sponsor class: INDUSTRY
First posted: 2024-12-05
Enrollment: 6000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed description: The CCANED-CIPHER study aims to revolutionise cancer diagnostics and treatment monitoring by developing and evaluating an AI-based early cancer detection tool that profiles RNA biomarkers from platelets and immune cells in blood samples. This non-invasive approach leverages liquid biopsy methods to enhance early cancer detection and provide insights into therapeutic responses.

Phase 1 (Common Cancer Early Detection \[CCANED\]): Early Cancer Detection

Objective:

To identify specific platelet-derived RNA biomarkers that can distinguish individuals with common cancers from healthy controls using AI-driven transcriptomic analysis.

Methodology:

* Enrol 3,500 patients with confirmed diagnoses of various common cancers and 1,500 cancer-free controls matched by age and sex.
* Obtain a single blood sample from each participant at baseline.

Laboratory Analysis:

* Platelet Isolation from blood samples.
* RNA Sequencing and transcriptomic profiling to identify RNA expression patterns.

Data Analysis:

* Use machine learning algorithms to analyse RNA data and identify biomarkers indicative of cancer presence.
* Assess sensitivity and specificity of the diagnostic tool, and evaluate its ability to differentiate between cancer types.

Expected Outcomes:

* Identification of reliable RNA biomarkers for early cancer detection.
* Validation of the AI-based diagnostic tool's accuracy and feasibility in a clinical setting.

Phase 2 ( Cancer Immuno-Profiling of Hematologic and Extracellular RNA \[CIPHER\]): Therapeutic Response Monitoring

Objective:

To evaluate how RNA biomarkers from immune cells and platelets correlate with therapeutic responses, providing insights into treatment efficacy and potential relapse.

Methodology:

* Enrol 1,000 cancer patients diagnosed with HCC or NSCLC across stages I to IV.
* Baseline: Collect blood samples before therapy initiation.
* Follow-Up: Additional samples at 6 weeks and 6 months post-therapy initiation.

Laboratory Analysis:

* Isolation of Immune Cells and Platelets from blood samples.
* Analysis of RNA expression changes over time.

Data Analysis:

* Evaluate associations between RNA biomarkers and clinical treatment responses.
* Develop models integrating platelet and immune cell RNA profiles to predict outcomes.

Expected Outcomes:

* Identification of biomarkers that correlate with treatment responses and progression-free survival.
* Development of predictive models for relapse and drug resistance.

Significance of the Study

The CCANED-CIPHER study addresses critical needs in oncology by providing:

* A blood test that reduces the need for invasive tissue biopsies.
* Potential for identifying cancers at an earlier, more treatable stage.
* Tailored treatment strategies based on individual biomarker profiles.
* Enhanced ability to monitor treatment effectiveness and adjust therapies accordingly.
* Early detection of relapse or drug resistance, enabling prompt clinical interventions.

Expected Impact and Future Applications: The identification of specific RNA biomarkers from platelets and immune cells has the potential to transform current practices in oncology, offering a more efficient, accurate and patient-friendly approach to cancer care.

Eligibility 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.

Primary outcomes:
measure: Identification of Platelet RNA Biomarkers Distinguishing Cancer Patients from Controls
timeFrame: Baseline (single time point)
measure: Identification of RNA Biomarkers Correlating with Therapeutic Response (Phase 2)
timeFrame: Baseline to 6 months post-therapy initiation
measure: Association Between Immune Cell Transcriptomes and AI-Based Platelet Signals
timeFrame: Baseline to 6 months post-therapy initiation
Secondary outcomes:
measure: Sensitivity and Specificity of the AI-Based Diagnostic Tool (Phase 1)
timeFrame: Baseline
measure: Feasibility of Platelet Transcriptomic Profiling Implementation
timeFrame: Phase 1 - 2 years
measure: Development of Predictive Models for Treatment Outcomes (Phase 2)
timeFrame: Phase 2 - Two years
measure: Identification of Biomarkers Predictive of Relapse and Drug Resistance (Phase 2)
timeFrame: Baseline to 6 months post-therapy initiation
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Various Cancer Centres
city: Lagos
country: Nigeria
facility: NSIA- Lagos University Teaching Hospital Cancer Centre
city: London
country: United Kingdom
facility: Dysplasia Diagnostics Limited
Study officials:
affiliation: Dysplasia Diagnostics Limited
name: Solomon Rotimi, PhD
role: STUDY_DIRECTOR
affiliation: Dysplasia Diagnostics Limited
name: Javier Toledo, Medical Degree
role: PRINCIPAL_INVESTIGATOR
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