Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer

NCT06654622 | Completed DMC

• 1 other identifier: 23228/CRMRD
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to establish an exosome-based liquid biopsy signature to detect molecular residual disease (MRD) in stage II-III colorectal cancer (CRC) patients. Identifying patients with MRD after surgery is crucial for selecting appropriate candidates for adjuvant chemotherapy (ACT), allowing for more personalized treatment approaches and potentially improving patient outcomes.

Conditions

Colo-rectal Cancer; Colorectal Cancer Recurrent

Keywords

Colorectal cancer; Molecular residual disease; Adjuvant chemotherapy; Stage II-III CRC; exosomal miRNA

Outcome Measures

Primary Outcomes (1)

• Tumor Evaluation (Recurrence)

  Assessment of tumor recurrence through clinical and imaging evaluations.

  Follow-up at regular intervals during the first 3 years post-surgery.

Secondary Outcomes (1)

• Overall Survival (OS)

  Patients will be monitored for overall survival for up to 5 years post-surgery.

Study Arms (4)

Training Cohort (Recurrence Group)

Stage II-III CRC patients who experienced postoperative recurrence (evaluated by miRNA panel).

Training Cohort (Non-Recurrence Group)

Stage II-III CRC patients who did not experience postoperative recurrence (evaluated by miRNA panel).

Testing Cohort (Recurrence Group)

Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who experienced postoperative recurrence.

Testing Cohort (Non-Recurrence Group)

Validation of miRNA panel and EMRATI score in independent stage II-III CRC patients who did not experience postoperative recurrence.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll patients with stage II-III colorectal cancer who have undergone curative surgery and require assessment for molecular residual disease to determine whether adjuvant chemotherapy is necessary.

You may qualify if:

• Patients with pathologically confirmed stage II or III colorectal cancer.
• Patients who have undergone curative-intent surgery.
• Patients with no evidence of distant metastasis (stage IV).
• Patients aged 18 years or older.
• Patients who provided written informed consent.

You may not qualify if:

• Patients with stage IV cancer or those receiving neoadjuvant therapy.
• Patients with non-curative resection or requiring urgent surgery.
• Patients with a follow-up period of fewer than 3 years.
• Patients with severe comorbidities or who are unable to participate in follow-up assessments.

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (10)

• Zhou H, Zhu L, Song J, Wang G, Li P, Li W, Luo P, Sun X, Wu J, Liu Y, Zhu S, Zhang Y. Liquid biopsy at the frontier of detection, prognosis and progression monitoring in colorectal cancer. Mol Cancer. 2022 Mar 25;21(1):86. doi: 10.1186/s12943-022-01556-2.

  PMID: 35337361 BACKGROUND

• Ruiz-Banobre J, Roy R, Alustiza Fernandez M, Murcia O, Jover R, Pera M, Balaguer F, Lopez-Lopez R, Goel A. Clinical significance of a microRNA signature for the identification and predicting prognosis in colorectal cancers with mucinous differentiation. Carcinogenesis. 2020 Nov 13;41(11):1498-1506. doi: 10.1093/carcin/bgaa097.

  PMID: 32911537 BACKGROUND

• Matsuyama T, Toiyama Y, Ishikawa T, Okugawa Y, Yasuno M, Maurel J, Kinugasa Y, Uetake H, Goel A. A metastasis-associated microRNA-based liquid biopsy signature for risk-stratification in colorectal cancer: a multicenter cohort study. Clin Transl Med. 2022 Dec;12(12):e998. doi: 10.1002/ctm2.998. No abstract available.

  PMID: 36513881 BACKGROUND

• Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.

  PMID: 36609320 BACKGROUND

• Mo S, Ye L, Wang D, Han L, Zhou S, Wang H, Dai W, Wang Y, Luo W, Wang R, Xu Y, Cai S, Liu R, Wang Z, Cai G. Early Detection of Molecular Residual Disease and Risk Stratification for Stage I to III Colorectal Cancer via Circulating Tumor DNA Methylation. JAMA Oncol. 2023 Jun 1;9(6):770-778. doi: 10.1001/jamaoncol.2023.0425.

  PMID: 37079312 BACKGROUND

• Yoshino T, Argiles G, Oki E, Martinelli E, Taniguchi H, Arnold D, Mishima S, Li Y, Smruti BK, Ahn JB, Faud I, Chee CE, Yeh KH, Lin PC, Chua C, Hasbullah HH, Lee MA, Sharma A, Sun Y, Curigliano G, Bando H, Lordick F, Yamanaka T, Tabernero J, Baba E, Cervantes A, Ohtsu A, Peters S, Ishioka C, Pentheroudakis G. Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis treatment and follow-up of patients with localised colon cancer. Ann Oncol. 2021 Dec;32(12):1496-1510. doi: 10.1016/j.annonc.2021.08.1752. Epub 2021 Aug 16.

  PMID: 34411693 BACKGROUND

• Montcusi B, Madrid-Gambin F, Marin S, Mayol X, Pascual M, Cascante M, Pozo OJ, Pera M. Circulating Metabolic Markers Identify Patients at Risk for Tumor Recurrence: A Prospective Cohort Study in Colorectal Cancer Surgery. Ann Surg. 2024 Nov 1;280(5):842-849. doi: 10.1097/SLA.0000000000006463. Epub 2024 Aug 1.

  PMID: 39087328 BACKGROUND

• Kotani D, Oki E, Nakamura Y, Yukami H, Mishima S, Bando H, Shirasu H, Yamazaki K, Watanabe J, Kotaka M, Hirata K, Akazawa N, Kataoka K, Sharma S, Aushev VN, Aleshin A, Misumi T, Taniguchi H, Takemasa I, Kato T, Mori M, Yoshino T. Molecular residual disease and efficacy of adjuvant chemotherapy in patients with colorectal cancer. Nat Med. 2023 Jan;29(1):127-134. doi: 10.1038/s41591-022-02115-4. Epub 2023 Jan 16.

  PMID: 36646802 BACKGROUND

• Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4.

  PMID: 35657320 BACKGROUND

• Kandimalla R, Gao F, Matsuyama T, Ishikawa T, Uetake H, Takahashi N, Yamada Y, Becerra C, Kopetz S, Wang X, Goel A. Genome-wide Discovery and Identification of a Novel miRNA Signature for Recurrence Prediction in Stage II and III Colorectal Cancer. Clin Cancer Res. 2018 Aug 15;24(16):3867-3877. doi: 10.1158/1078-0432.CCR-17-3236. Epub 2018 Mar 7.

  PMID: 29514841 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Postoperative serum samples will be used to isolate exosomal miRNAs for MRD analysis.

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: April 1, 2023
• Primary Completion: January 18, 2026
• Study Completion: February 18, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)