Clinical trial · Observational
The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling
NCT06717295CI-TRIAL-00100036CCANED-CIPHERrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brest Cancer | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Glioblastoma (GBM) | Glioblastoma | CURATED_BROADER | 0.80 |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer, Adult | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.85 |
| Prostate Cancers | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DiNanoQ: A multi-cancer early detection (MCED) blood test | Diagnostic Test | — | UNRESOLVED |
| DiNanoTrack: Therapeutic Response Monitoring Blood Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cancer Patients (Phase 1)
- description
- 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.
- interventionNames
- Diagnostic Test: DiNanoQ: A multi-cancer early detection (MCED) blood test
- label
- Healthy Individuals
- description
- This arm will consist of 1,500 age- and sex-matched cancer-free individuals serving as controls.
- interventionNames
- Diagnostic Test: DiNanoQ: A multi-cancer early detection (MCED) blood test
- label
- Cancer Patients Undergoing Treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (29)
- BACKGROUNDTsui NB, Ng EK, Lo YM. Stability of endogenous and added RNA in blood specimens, serum, and plasma. Clin Chem. 2002 Oct;48(10):1647-53. PMID 12324479
- BACKGROUNDNational Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641
- BACKGROUNDSmerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2. PMID 24888818
- BACKGROUNDSiravegna G, Mussolin B, Buscarino M, Corti G, Cassingena A, Crisafulli G, Ponzetti A, Cremolini C, Amatu A, Lauricella C, Lamba S, Hobor S, Avallone A, Valtorta E, Rospo G, Medico E, Motta V, Antoniotti C, Tatangelo F, Bellosillo B, Veronese S, Budillon A, Montagut C, Racca P, Marsoni S, Falcone A, Corcoran RB, Di Nicolantonio F, Loupakis F, Siena S, Sartore-Bianchi A, Bardelli A. Clonal evolution and resistance to EGFR blockade in the blood of colorectal cancer patients. Nat Med. 2015 Jul;21(7):795-801. doi: 10.1038/nm.3870. Epub 2015 Jun 1. PMID 26030179
- BACKGROUNDSharma SV, Lee DY, Li B, Quinlan MP, Takahashi F, Maheswaran S, McDermott U, Azizian N, Zou L, Fischbach MA, Wong KK, Brandstetter K, Wittner B, Ramaswamy S, Classon M, Settleman J. A chromatin-mediated reversible drug-tolerant state in cancer cell subpopulations. Cell. 2010 Apr 2;141(1):69-80. doi: 10.1016/j.cell.2010.02.027. PMID 20371346
- BACKGROUNDSequist LV, Waltman BA, Dias-Santagata D, Digumarthy S, Turke AB, Fidias P, Bergethon K, Shaw AT, Gettinger S, Cosper AK, Akhavanfard S, Heist RS, Temel J, Christensen JG, Wain JC, Lynch TJ, Vernovsky K, Mark EJ, Lanuti M, Iafrate AJ, Mino-Kenudson M, Engelman JA. Genotypic and histological evolution of lung cancers acquiring resistance to EGFR inhibitors. Sci Transl Med. 2011 Mar 23;3(75):75ra26. doi: 10.1126/scitranslmed.3002003.