Early-Onset Colorectal Cancer Recurrence

NCT06271980 | Completed

• 1 other identifier: 23228/ENCORE
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

Survivors of early-onset colorectal cancer (diagnosed before age 50) may experience colorectal cancer recurrence several years after curative-intent treatments, but clinical guidelines provide unclear guidance on endoscopic surveillance. This study aims to predict recurrence-free survival and overall survival, in survivors of early-onset colorectal cancer, using a tumor-based molecular assay based on microRNA (ribonucleic acid)

Conditions

Colorectal Cancer Recurrent; Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colorectal Cancer Stage I; Colorectal Cancer Stage II; Colorectal Cancer Stage III

Keywords

Early-Onset; Young-Onset; Surveillance; micro-RNA; Prediction

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  Time from disease treatment to development of recurrent colorectal cancer

  Up to 120 months

Secondary Outcomes (1)

• Overall Survival

  Up to 120 months

Study Arms (4)

Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort)

Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the first cohort

Other: ENCORE

Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort)

Survivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the first cohort

Other: ENCORE

Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort)

Survivors of early-onset colorectal cancer who developed recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort

Other: ENCORE

Survivors of early-onset colorectal cancer, with no recurrent disease (Validation Cohort)

Survivors of early-onset colorectal cancer who did not develop recurrent CRC within 60 months from primary tumor treatment, in the second, independent, validation cohort

Other: ENCORE

Interventions

ENCORE OTHER

A panel of microRNA, whose expression level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.

Also known as: ENCORE (Early oNset COlorectal cancer REcurrence)

Survivors of early-onset colorectal cancer, with no recurrent disease (Training Cohort); Survivors of early-onset colorectal cancer, with no recurrent disease (Validation Cohort); Survivors of early-onset colorectal cancer, with recurrent disease (Training Cohort); Survivors of early-onset colorectal cancer, with recurrent disease (Validation Cohort)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Two independent cohorts of early-onset colorectal cancer survivors (stages I-III)

You may qualify if:

• Stage I, II, or III colorectal cancer (TNM classification, 8th edition) diagnosed before the age of 50
• Received standard diagnostic, staging, and therapeutic procedures as per local guidelines, received stage-specific curative-intent resection (with or without systemic therapy, as appropriate)

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
• IRCCS San Raffaele: collaborator
• Institute of Biomedical Research of Salamanca, Salamanca, Spain: collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (19)

• Sinicrope FA. Increasing Incidence of Early-Onset Colorectal Cancer. N Engl J Med. 2022 Apr 21;386(16):1547-1558. doi: 10.1056/NEJMra2200869. No abstract available.

  PMID: 35443109 BACKGROUND

• Siegel RL, Wagle NS, Cercek A, Smith RA, Jemal A. Colorectal cancer statistics, 2023. CA Cancer J Clin. 2023 May-Jun;73(3):233-254. doi: 10.3322/caac.21772. Epub 2023 Mar 1.

  PMID: 36856579 BACKGROUND

• Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.

  PMID: 38230766 BACKGROUND

• Kim TJ, Kim ER, Hong SN, Chang DK, Kim YH. Long-Term Outcome and Prognostic Factors of Sporadic Colorectal Cancer in Young Patients: A Large Institutional-Based Retrospective Study. Medicine (Baltimore). 2016 May;95(19):e3641. doi: 10.1097/MD.0000000000003641.

  PMID: 27175682 BACKGROUND

• You YN, Dozois EJ, Boardman LA, Aakre J, Huebner M, Larson DW. Young-onset rectal cancer: presentation, pattern of care and long-term oncologic outcomes compared to a matched older-onset cohort. Ann Surg Oncol. 2011 Sep;18(9):2469-76. doi: 10.1245/s10434-011-1674-7. Epub 2011 Mar 30.

  PMID: 21448750 BACKGROUND

• Foppa C, Tamburello S, Maroli A, Carvello M, Poliani L, Laghi L, Malesci A, Montorsi M, Perea J, Spinelli A. Early age of onset is an independent predictor for worse disease-free survival in sporadic rectal cancer patients. A comparative analysis of 980 consecutive patients. Eur J Surg Oncol. 2022 Apr;48(4):857-863. doi: 10.1016/j.ejso.2021.10.021. Epub 2021 Oct 28.

  PMID: 34740480 BACKGROUND

• Kim SB, Lee HJ, Park SJ, Hong SP, Cheon JH, Kim WH, Kim TI. Comparison of Colonoscopy Surveillance Outcomes Between Young and Older Colorectal Cancer Patients. J Cancer Prev. 2017 Sep;22(3):159-165. doi: 10.15430/JCP.2017.22.3.159. Epub 2017 Sep 30.

  PMID: 29018780 BACKGROUND

• Chen FW, Sundaram V, Chew TA, Ladabaum U. Advanced-Stage Colorectal Cancer in Persons Younger Than 50 Years Not Associated With Longer Duration of Symptoms or Time to Diagnosis. Clin Gastroenterol Hepatol. 2017 May;15(5):728-737.e3. doi: 10.1016/j.cgh.2016.10.038. Epub 2016 Nov 14.

  PMID: 27856366 BACKGROUND

• Al Maliki H, Monahan KJ. The diagnostic yield of colonoscopic surveillance following resection of early age onset colorectal cancer. United European Gastroenterol J. 2024 May;12(4):469-476. doi: 10.1002/ueg2.12516. Epub 2024 Jan 3.

  PMID: 38170450 BACKGROUND

• Peacock O, Vilar E, Guraieb-Trueba M, Thirumurthi S, Chang GJ, You YN. Clinically Significant Metachronous Colorectal Pathology Detected Among Young-Onset Colorectal Cancer Survivors: Implications for Post-Resection Surveillance Guidelines. Gastroenterology. 2022 Dec;163(6):1682-1684.e2. doi: 10.1053/j.gastro.2022.08.030. Epub 2022 Aug 17. No abstract available.

  PMID: 35987446 BACKGROUND

• Zaborowski AM, Murphy B, Creavin B, Rogers AC, Kennelly R, Hanly A, Martin ST, O'Connell PR, Sheahan K, Winter DC. Clinicopathological features and oncological outcomes of patients with young-onset rectal cancer. Br J Surg. 2020 Apr;107(5):606-612. doi: 10.1002/bjs.11526. Epub 2020 Mar 9.

  PMID: 32149397 BACKGROUND

• Bouvier AM, Latournerie M, Jooste V, Lepage C, Cottet V, Faivre J. The lifelong risk of metachronous colorectal cancer justifies long-term colonoscopic follow-up. Eur J Cancer. 2008 Mar;44(4):522-7. doi: 10.1016/j.ejca.2008.01.007. Epub 2008 Feb 5.

  PMID: 18255278 BACKGROUND

• Monahan KJ, Bradshaw N, Dolwani S, Desouza B, Dunlop MG, East JE, Ilyas M, Kaur A, Lalloo F, Latchford A, Rutter MD, Tomlinson I, Thomas HJW, Hill J; Hereditary CRC guidelines eDelphi consensus group. Guidelines for the management of hereditary colorectal cancer from the British Society of Gastroenterology (BSG)/Association of Coloproctology of Great Britain and Ireland (ACPGBI)/United Kingdom Cancer Genetics Group (UKCGG). Gut. 2020 Mar;69(3):411-444. doi: 10.1136/gutjnl-2019-319915. Epub 2019 Nov 28.

  PMID: 31780574 BACKGROUND

• Rutter MD, East J, Rees CJ, Cripps N, Docherty J, Dolwani S, Kaye PV, Monahan KJ, Novelli MR, Plumb A, Saunders BP, Thomas-Gibson S, Tolan DJM, Whyte S, Bonnington S, Scope A, Wong R, Hibbert B, Marsh J, Moores B, Cross A, Sharp L. British Society of Gastroenterology/Association of Coloproctology of Great Britain and Ireland/Public Health England post-polypectomy and post-colorectal cancer resection surveillance guidelines. Gut. 2020 Feb;69(2):201-223. doi: 10.1136/gutjnl-2019-319858. Epub 2019 Nov 27.

  PMID: 31776230 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

• Jung G, Hernandez-Illan E, Moreira L, Balaguer F, Goel A. Epigenetics of colorectal cancer: biomarker and therapeutic potential. Nat Rev Gastroenterol Hepatol. 2020 Feb;17(2):111-130. doi: 10.1038/s41575-019-0230-y. Epub 2020 Jan 3.

  PMID: 31900466 BACKGROUND

• Okugawa Y, Grady WM, Goel A. Epigenetic Alterations in Colorectal Cancer: Emerging Biomarkers. Gastroenterology. 2015 Oct;149(5):1204-1225.e12. doi: 10.1053/j.gastro.2015.07.011. Epub 2015 Jul 26.

  PMID: 26216839 BACKGROUND

• Nakamura K, Hernandez G, Sharma GG, Wada Y, Banwait JK, Gonzalez N, Perea J, Balaguer F, Takamaru H, Saito Y, Toiyama Y, Kodera Y, Boland CR, Bujanda L, Quintero E, Goel A. A Liquid Biopsy Signature for the Detection of Patients With Early-Onset Colorectal Cancer. Gastroenterology. 2022 Nov;163(5):1242-1251.e2. doi: 10.1053/j.gastro.2022.06.089. Epub 2022 Jul 16.

  PMID: 35850198 BACKGROUND

• Mannucci A, Hernandez G, Uetake H, Yamada Y, Balaguer F, Baba H, Chen T, Chen J, Boland CR, Cavestro GM, Quintero E, Goel A. Prediction of long-term recurrence-free and overall survival in early-onset colorectal cancer: the ENCORE multi-centre study. NPJ Precis Oncol. 2025 Jun 21;9(1):202. doi: 10.1038/s41698-025-00978-7.

  PMID: 40544180 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

enc protein, Drosophila

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

Study Design

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

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)