Early Onset Colorectal Cancer Detection

NCT06342401 | Recruiting

• 1 other identifier: 23228/ENCODE
• Study Type: observational
• Target: 400
• Locations: 4 countries
• Sites: 13

Brief 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 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)

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colorectal Cancer Stage I; Colorectal Neoplasms Malignant; Colorectal Cancer Stage IV; Colorectal Cancer Stage II; Colorectal Cancer Stage III

Keywords

Early onset; Young onset; Young adult; micro-RNA; Rectal cancer; Cancer of the young; Cancer detection; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• Sensitivity

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

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Specificity

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

Study Arms (4)

Early onset colorectal cancer (Training cohort)

Colorectal cancer diagnosed before the age of 50

Diagnostic Test: ENCODE

Non-disease controls (Training cohort)

Individuals free from colorectal cancer, younger than 50 years of age

Diagnostic Test: ENCODE

Early onset colorectal cancer (Validation cohort)

Colorectal cancer diagnosed before the age of 50

Diagnostic Test: ENCODE

Non-disease controls (Validation cohort)

Individuals free from colorectal cancer, younger than 50 years of age

Diagnostic Test: ENCODE

Interventions

ENCODE DIAGNOSTIC_TEST

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.

Also known as: ENCODE (Early oNset COlorectal cancer DEtection)

Early onset colorectal cancer (Training cohort); Early onset colorectal cancer (Validation cohort); Non-disease controls (Training cohort); Non-disease controls (Validation cohort)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (13)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

IRCCS San Raffaele

Milan, Italy

RECRUITING

Kawasaki University

Kawasaki, Japan

RECRUITING

Mie University

Mie, Japan

RECRUITING

National Cancer Center Hospital

Tokyo, Japan

RECRUITING

Tokyo Medical and Dental University

Tokyo, Japan

RECRUITING

Yamagata University

Yamagata, Japan

RECRUITING

Barcelona University

Barcelona, Spain

RECRUITING

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

Barcelona, Spain

RECRUITING

Surgery Department, Hospital del Mar, Barcelona, Spain

Barcelona, Spain

RECRUITING

Salamanca Biomedical Research Institute

Madrid, Spain

RECRUITING

University of Salamanca-SACYL-CSIC, Salamanca, Spain

Salamanca, Spain

RECRUITING

University of La Laguna

San Cristóbal de La Laguna, Spain

RECRUITING

Related Publications (11)

• 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.

  PMID: 30207593 BACKGROUND

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 35090605 BACKGROUND

• 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.

  PMID: 33219329 BACKGROUND

• 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.

  PMID: 31455888 BACKGROUND

• 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.

  PMID: 36549470 BACKGROUND

• 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.

  PMID: 37370811 BACKGROUND

• 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.

  PMID: 37935108 BACKGROUND

• 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.

  PMID: 32525015 BACKGROUND

• 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.

  PMID: 34862279 BACKGROUND

• 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.

  PMID: 41364052 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ajay Goel, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Goel, PhD

CONTACT

626-218-3452; AJGOEL@COH.ORG

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: April 15, 2023
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

ES (6); JP (5); IT (1); US (1)