Study Results
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Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-03-15
2026-06-18
Brief Summary
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Detailed Description
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This study will comprise three phases
1. A systematic and comprehensive CpG methylation-based epigenetic biomarker discovery phase to identify the differentially methylated CpG sites associated with recurrence-free survival (RFS) \< 5 years and \> 5 years. In this phase, LASSO-based machine learning algorithms will be used to optimize the biomarker candidates.
2. A tissue-based clinical assay development phase by quantitative pyrosequencing
3. An independent validation phase.
At completion, this study will validate a tissue-based assay to predict the development of recurrence after the completion of chemotherapy in patients with stage III and II CRC
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Stage II/III Colorectal Cancer, with Recurrence (Training)
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
CENSURE
A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
Stage II/III Colorectal Cancer, without Recurrence (Training)
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.
CENSURE
A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
Stage II/III Colorectal Cancer, with Recurrence (Validation)
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and experienced recurrence within five years.
CENSURE
A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
Stage II/III Colorectal Cancer, without Recurrence (Validation)
Stage II/III Colorectal Cancer patients who received treatment with surgery and adjuvant chemotherapy, and did not experience recurrence within five years.
CENSURE
A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
Interventions
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CENSURE
A panel of CpG sites, whose methylation level is tested in macro-dissected formalin-fixed and paraffin-embedded (FFPE) samples derived from the primary tumor.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received standard diagnostic, staging, and therapeutic procedures as per local guidelines
* Received stage-specific curative-intent resection followed by adjuvant chemotherapy.
* Confirmed cancer-free survivorship confirmed at the time of study inclusion.
Exclusion Criteria
* Development of recurrence in the first 6 months following adjuvant chemotherapy completion.
* Hereditary colorectal cancer syndromes (identified through genetic testing)
* Inflammatory bowel diseases
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ajay Goel, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Monrovia, California, United States
Second Affiliated Hospital of Dalian Medical University
Dalian, , China
Barcelona University
Barcelona, , Spain
La Paz University Hospital
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Frei AL, McGuigan A, Sinha RRAK, Jabbar F, Gneo L, Tomasevic T, Harkin A, Iveson T, Saunders MP, Oien KA, Maka N, Pezzella F, Campo L, Browne M, Glaire M, Kildal W, Danielsen HE, Hay J, Edwards J, Sansom O, Kelly C, Tomlinson I, Kerr R, Kerr D, Domingo E; TransSCOT consortium; Church DN, Koelzer VH. Multiplex analysis of intratumoural immune infiltrate and prognosis in patients with stage II-III colorectal cancer from the SCOT and QUASAR 2 trials: a retrospective analysis. Lancet Oncol. 2024 Feb;25(2):198-211. doi: 10.1016/S1470-2045(23)00560-0.
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Bockelman C, Engelmann BE, Kaprio T, Hansen TF, Glimelius B. Risk of recurrence in patients with colon cancer stage II and III: a systematic review and meta-analysis of recent literature. Acta Oncol. 2015 Jan;54(1):5-16. doi: 10.3109/0284186X.2014.975839. Epub 2014 Nov 28.
Cheng E, Ou FS, Ma C, Spiegelman D, Zhang S, Zhou X, Bainter TM, Saltz LB, Niedzwiecki D, Mayer RJ, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Giovannucci EL, Van Blarigan EL, Brown JC, Ng K, Gross CP, Meyerhardt JA, Fuchs CS. Diet- and Lifestyle-Based Prediction Models to Estimate Cancer Recurrence and Death in Patients With Stage III Colon Cancer (CALGB 89803/Alliance). J Clin Oncol. 2022 Mar 1;40(7):740-751. doi: 10.1200/JCO.21.01784. Epub 2022 Jan 7.
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Henriksen TV, Tarazona N, Frydendahl A, Reinert T, Gimeno-Valiente F, Carbonell-Asins JA, Sharma S, Renner D, Hafez D, Roda D, Huerta M, Rosello S, Madsen AH, Love US, Andersen PV, Thorlacius-Ussing O, Iversen LH, Gotschalck KA, Sethi H, Aleshin A, Cervantes A, Andersen CL. Circulating Tumor DNA in Stage III Colorectal Cancer, beyond Minimal Residual Disease Detection, toward Assessment of Adjuvant Therapy Efficacy and Clinical Behavior of Recurrences. Clin Cancer Res. 2022 Feb 1;28(3):507-517. doi: 10.1158/1078-0432.CCR-21-2404. Epub 2021 Oct 8.
Romesser PB, Sanchez-Vega F, Joshua Smith J. A methylation-based prognostic signature in stage II colorectal patients: Considerations for clinical adoption. J Natl Cancer Inst. 2023 Jan 10;115(1):8-11. doi: 10.1093/jnci/djac184. No abstract available.
Other Identifiers
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23228/CENSURE
Identifier Type: -
Identifier Source: org_study_id
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