Clinical trial · Observational
The Predictive Value of Guangzhou Panel for Recurrence in Early-stage Colorectal Cancer
NCT03923335CI-TRIAL-00038264not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the predictive value of a four-gene methylation assay called Guangzhou Panel in early-stage colorectal cancer. Patients will be divided into two groups: high risk group and low risk group. The primary endpoint is 5 year disease free survival (DFS).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA methylation detection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- high-risk group
- description
- patients with any of the four genes hypermethylated
- interventionNames
- Other: DNA methylation detection
- label
- low-risk group
- description
- patients with none of the four genes hypermethylated
- interventionNames
- Other: DNA methylation detection
Primary outcomes (1)
- measure
- disease free survival
- timeFrame
- From date of operation until the date of first recurrence or date of death from any cause, whichever came first, assessed up to 5 years
- description
- the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. TNM stage I-II (T1-4N0M0) colorectal cancer cases 2. receive radical surgical resection 3. have completed data of tumor location, histological type, behavioral characteristics or TNM staging 4. have tumor specimens and either a valid microsatellite instability (MSI) or immuno-histochemistry (IHC) data 5. have valid V-raf murine sarcoma viral oncogene homolog B1 (BRAF), kirsten rat sarcoma viral oncogene (KRAS), CpG island methylator phenotype (CIMP) results 6. have at least 4 years of follow-up 7. have valid time to local recurrence/metastasis in follow-up 8. have clinical/treatment record data and valid preoperative status of intestinal obstruction or perforation (IOP), counts of lymph node removed in surgical resection. Exclusion Criteria: 1. have had a previous diagnosis of any cancer or presence of any tumor other than the CRC 2. have had inflammatory bowel disease 3. have had hereditary colorectal cancer syndromes, including Familial adenomatous polyposis, mutyh (MYH)-associated polyposis, Peutz-Jeghers syndrome, Juvenile polyposis coli, phosphate and tension homology deleted on chromosome ten (PTEN) tumor-hamartoma syndromes, Lynch Syndrome, and Familial Colorectal Cancer Type X.
References
Publications (16)
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- BACKGROUNDO'Connor ES, Greenblatt DY, LoConte NK, Gangnon RE, Liou JI, Heise CP, Smith MA. Adjuvant chemotherapy for stage II colon cancer with poor prognostic features. J Clin Oncol. 2011 Sep 1;29(25):3381-8. doi: 10.1200/JCO.2010.34.3426. Epub 2011 Jul 25. PMID 21788561
- BACKGROUNDBrenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11. PMID 24225001
- BACKGROUNDQuasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2. PMID 18083404
- BACKGROUNDMorris EJ, Maughan NJ, Forman D, Quirke P. Who to treat with adjuvant therapy in Dukes B/stage II colorectal cancer? The need for high quality pathology. Gut. 2007 Oct;56(10):1419-25. doi: 10.1136/gut.2006.116830. Epub 2007 May 9. PMID 17494107
- BACKGROUNDRibic CM, Sargent DJ, Moore MJ, Thibodeau SN, French AJ, Goldberg RM, Hamilton SR, Laurent-Puig P, Gryfe R, Shepherd LE, Tu D, Redston M, Gallinger S. Tumor microsatellite-instability status as a predictor of benefit from fluorouracil-based adjuvant chemotherapy for colon cancer. N Engl J Med. 2003 Jul 17;349(3):247-57. doi: 10.1056/NEJMoa022289. PMID 12867608
- BACKGROUNDKennedy RD, Bylesjo M, Kerr P, Davison T, Black JM, Kay EW, Holt RJ, Proutski V, Ahdesmaki M, Farztdinov V, Goffard N, Hey P, McDyer F, Mulligan K, Mussen J, O'Brien E, Oliver G, Walker SM, Mulligan JM, Wilson C, Winter A, O'Donoghue D, Mulcahy H, O'Sullivan J, Sheahan K, Hyland J, Dhir R, Bathe OF, Winqvist O, Manne U, Shanmugam C, Ramaswamy S, Leon EJ, Smith WI Jr, McDermott U, Wilson RH, Longley D, Marshall J, Cummins R, Sargent DJ, Johnston PG, Harkin DP. Development and independent validation of a prognostic assay for stage II colon cancer using formalin-fixed paraffin-embedded tissue. J Clin Oncol. 2011 Dec 10;29(35):4620-6. doi: 10.1200/JCO.2011.35.4498. Epub 2011 Nov 7.