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AzTrials

Colorectal CancerENCODENCT06342401

Early Onset Colorectal Cancer Detection

An observational study of Colorectal Cancer and Colorectal Neoplasms, run by City of Hope Medical Center at 13 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
ENCODE
How many people
400 participants
Where
13 sitesin 4 countries
Study dates
15 Apr 2023to 18 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Individuals younger than 50 years of age who were diagnosed with colorectal cancer before the age of 50 (cases) or were free from colorectal cancer at the time of study inclusion (controls)

Who may be able to join

  • Stage I, II, III, IV colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50 (EOCRC cases)
  • Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment
  • Colonoscopy-proven cancer-free status at the time of study inclusion (Non-disease controls)

Who cannot join

  • Hereditary colorectal cancer syndromes (identified through genetic testing)
  • Inflammatory bowel diseases
  • Lack of written informed consent

Trial locations and contacts

13 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Ajay Goel, PhD contact

626-218-3452

AJGOEL@COH.ORG

13 sites in 4 countries

Spain6 sites, 6 recruiting

  • Barcelona University

    Barcelona

    Francesc Balaguer, MD, PhD, fprunes@clinic.cat

    Recruiting

  • Colorectal Surgery, Vall d'Hebron University Hospital, Universitat Autonoma de Barcelona UAB

    Barcelona

    Marc Martí-Gallostra, mmgallostra@vhebron.net

    Recruiting

  • Surgery Department, Hospital del Mar, Barcelona, Spain

    Barcelona

    Marta Jiménez-Toscano, mjimeneztoscano@psmar.cat

    Recruiting

  • Salamanca Biomedical Research Institute

    Madrid

    Jose Perea, MD, josepereag@hotmail.com

    Jose Perea, MD

    Recruiting

  • University of Salamanca-SACYL-CSIC, Salamanca, Spain

    Salamanca

    Rosario Vidal-Tocino, a119121@usal.es

    Recruiting

  • University of La Laguna

    San Cristóbal de La Laguna

    Recruiting

Other trials in Spain

Japan5 sites, 5 recruiting

  • Kawasaki University

    Kawasaki

    Recruiting

  • Mie University

    Mie

    Recruiting

  • National Cancer Center Hospital

    Tokyo

    Recruiting

  • Tokyo Medical and Dental University

    Tokyo

    Recruiting

  • Yamagata University

    Yamagata

    Recruiting

Other trials in Japan

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Ajay Goel, PhD, 626-218-3452, AJGOEL@COH.ORG

    Alessandro Mannucci, MD

    Recruiting

Other trials in United States

Italy1 site, 1 recruiting

  • IRCCS San Raffaele

    Milan

    Giulia Martina Cavestro, MD, PhD, cavestro.giuliamartina@hsr.it

    Alessandro Mannucci, MD

    Recruiting

Other trials in Italy

About this study

Official title: Development and Validation fo an Exosome-Based and Machine Learning Powered Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer

Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.

This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid)

Read the detailed description

The rising incidence of early-onset colorectal cancer (EOCRC) is a pressing clinical issue unique to our times, and it is expected to grow with an anticipated further 90% increase in incidence by the decade's end. Challenges persist even after reducing the CRC screening age to 45: under-45s lack routine screening and compliance in the 45-50 age group remains low, partly due to invasiveness and discomfort of standard screening methods. Urgent action is warranted to develop affordable, sensitive, and feasible screening for timely detection and improved participation. A non-invasive, patient-friendly screening test, like a blood-based assay, could address these epidemiological concerns and also attract underserved populations.

This study involves the development and validation of a liquid biopsy, assessing circulating cell-free and exosomal microRNAs (cf-miRNA and exo-miRNA, respectively) for indirect sampling of tumor tissue in the bloodstream. The researchers intend to harness machine learning and bioinformatics to create an integrated panel (with both cf-miRNAs and exo-miRNAs) to enhance the inherently high sensitivity of cf-miRNAs with the distinctive specificity of exo-miRNAs. This combined approach will not only improve the performance of a diagnostic model but will also tap into the diverse tumor biology aspects of EOCRC.

The study's core goal is to develop cost-efficient, non-invasive, clinic-friendly biomarkers with high sensitivity and specificity, aiding EOCRC detection.

The researchers intend to do so in three phases:

  1. To perform comprehensive small RNA-Seq from matched cf-miRNA, exo-miRNA, cancer-derived miRNA, and mucosa-derived miRNA.
  2. To develop and train two miRNA detection panels (cf-miRNA and exo-miRNA, respectively) based on advanced machine-learning models and, then, combine these two using several machine-learning models to obtain a final detection biomarker.
  3. To validate the findings in an independent cohort of EOCRC and controls.

In summary, this proposal promises to improve patient care and compliance, and, ultimately, reduce mortality from EOCRC.

Being tested
ENCODE
Keywords
Early onset, Young onset, Young adult, micro-RNA, Rectal cancer, Cancer of the young, Cancer detection, Liquid biopsy
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENCODEDiagnostic test

    Also called ENCODE (Early oNset COlorectal cancer DEtection)

    A panel of microRNA, both cell-free and exosomes, whose expression level is tested from plasma samples from patients with early onset colorectal cancer and non-disease controls.

Study groups in NCT06342401
Study groupRoleWhat they receive
Early onset colorectal cancer (Training cohort)Colorectal cancer diagnosed before the age of 50
Receives: Diagnostic Test: ENCODE
Non-disease controls (Training cohort)Individuals free from colorectal cancer, younger than 50 years of age
Receives: Diagnostic Test: ENCODE
Early onset colorectal cancer (Validation cohort)Colorectal cancer diagnosed before the age of 50
Receives: Diagnostic Test: ENCODE
Non-disease controls (Validation cohort)Individuals free from colorectal cancer, younger than 50 years of age
Receives: Diagnostic Test: ENCODE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity

    True Positive Rate: the probability of a positive test result, conditioned on the individual truly being positive

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

  1. Specificity

    True Negative Rate: the probability of a negative test result, conditioned on the individual truly being negative

    Measured: Through study completion, an average of 1 year

  2. Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy)

    A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start15 Apr 2023
  3. Primary completion18 Jun 2028 (estimated)
  4. Study completion18 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342401
Sponsor's protocol ID
23228/ENCODE
Acronym
ENCODE
Status last verified
Jul 2026
First submitted
26 Mar 2024
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Patel SG, Karlitz JJ, Yen T, Lieu CH, Boland CR. The rising tide of early-onset colorectal cancer: a comprehensive review of epidemiology, clinical features, biology, risk factors, prevention, and early detection. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):262-274. doi: 10.1016/S2468-1253(21)00426-X. Epub 2022 Jan 26.

    PubMed 35090605

  • Akimoto N, Ugai T, Zhong R, Hamada T, Fujiyoshi K, Giannakis M, Wu K, Cao Y, Ng K, Ogino S. Rising incidence of early-onset colorectal cancer - a call to action. Nat Rev Clin Oncol. 2021 Apr;18(4):230-243. doi: 10.1038/s41571-020-00445-1. Epub 2020 Nov 20.

    PubMed 33219329

  • Keum N, Giovannucci E. Global burden of colorectal cancer: emerging trends, risk factors and prevention strategies. Nat Rev Gastroenterol Hepatol. 2019 Dec;16(12):713-732. doi: 10.1038/s41575-019-0189-8. Epub 2019 Aug 27.

    PubMed 31455888

  • Cavestro GM, Mannucci A, Balaguer F, Hampel H, Kupfer SS, Repici A, Sartore-Bianchi A, Seppala TT, Valentini V, Boland CR, Brand RE, Buffart TE, Burke CA, Caccialanza R, Cannizzaro R, Cascinu S, Cercek A, Crosbie EJ, Danese S, Dekker E, Daca-Alvarez M, Deni F, Dominguez-Valentin M, Eng C, Goel A, Guillem JG, Houwen BBSL, Kahi C, Kalady MF, Kastrinos F, Kuhn F, Laghi L, Latchford A, Liska D, Lynch P, Malesci A, Mauri G, Meldolesi E, Moller P, Monahan KJ, Moslein G, Murphy CC, Nass K, Ng K, Oliani C, Papaleo E, Patel SG, Puzzono M, Remo A, Ricciardiello L, Ripamonti CI, Siena S, Singh SK, Stadler ZK, Stanich PP, Syngal S, Turi S, Urso ED, Valle L, Vanni VS, Vilar E, Vitellaro M, You YN, Yurgelun MB, Zuppardo RA, Stoffel EM; Associazione Italiana Familiarita Ereditarieta Tumori; Collaborative Group of the Americas on Inherited Gastrointestinal Cancer; European Hereditary Tumour Group, and the International Society for Gastrointestinal Hereditary Tumours. Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines. Clin Gastroenterol Hepatol. 2023 Mar;21(3):581-603.e33. doi: 10.1016/j.cgh.2022.12.006. Epub 2022 Dec 20.

    PubMed 36549470

  • Ullah F, Pillai AB, Omar N, Dima D, Harichand S. Early-Onset Colorectal Cancer: Current Insights. Cancers (Basel). 2023 Jun 15;15(12):3202. doi: 10.3390/cancers15123202.

    PubMed 37370811

  • Syed H, Sommovilla J, Burke CA, McGee S, Macaron C, Heald B, Lyu R, Schmit SL, Nair K, Kamath S, Krishnamurthi S, Khorana AA, Liska D. Referral, Uptake, and Outcome of Genetic Counseling and Testing in Patients With Early-Onset Colorectal Cancer. J Natl Compr Canc Netw. 2023 Nov;21(11):1156-1163.e5. doi: 10.6004/jnccn.2023.7057.

    PubMed 37935108

  • Boardman LA, Vilar E, You YN, Samadder J. AGA Clinical Practice Update on Young Adult-Onset Colorectal Cancer Diagnosis and Management: Expert Review. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2415-2424. doi: 10.1016/j.cgh.2020.05.058. Epub 2020 Jun 7.

    PubMed 32525015

  • Rogers CR, Brooks E, Curtin K, De Vera MA, Qeadan F, Rogers TN, Petersen E, Gallagher P, Pesmen C, Johnson W, Henley C, Hickman W, Newcomb E, Korous KM, Handley MA. Protocol for #iBeatCRC: a community-based intervention to increase early-onset colorectal cancer awareness using a sequential explanatory mixed-methods approach. BMJ Open. 2021 Dec 3;11(12):e048959. doi: 10.1136/bmjopen-2021-048959.

    PubMed 34862279

  • Mannucci A, Balaguer F, Yamada Y, Nagasaka T, Toiyama Y, Okugawa Y, Marti-Gallostra M, Jimenez-Toscano M, Vidal-Tocino R, Jimenez F, Perea J, Quintero E, Boland CR, Cavestro GM, Goel A; SECOC-ENCODER Collaborators. An Exosome-Based Liquid Biopsy for the Detection of Early-Onset Colorectal Cancer: The ENCODER Multicenter Study. Gastroenterology. 2026 Feb;170(2):330-343. doi: 10.1053/j.gastro.2025.08.013. Epub 2025 Dec 9.

    PubMed 41364052

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer and Colorectal Neoplasms, run by City of Hope Medical Center at 13 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Spain, Japan, United States, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ajay Goel, PhD (626-218-3452, AJGOEL@COH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342401, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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Early Onset Colorectal Cancer Detection (NCT06342401) | AzTrials