Confirmatory Study of Oncotype DX Colon Cancer Assay to Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence in Patients with Resected Stage II and Stage III Colon Cancer

Confirmatory Study of Oncotype DX Colon Cancer Assay to Assess the Relationship between Continuous Recurrence Score and the Likelihood of Recurrence in Patients with Resected Stage II and Stage III Colon Cancer - SUNRISE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009395

Enrollment

1500

Registered

2012-11-27

Start date

2012-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who had stage II or stage III colon cancer surgery (including rectosigmoid cancer ) from 2000 to 2005 and who underwent resection of a colon cancer including lymph node dissection &#8805; D2 (2) Patients who aged &#8805;20 and &#8804;80. (3) Patients who are histologically diagnosed with primary colon adenocarcinoma (4) Patients with sufficient FFPE sample (5) Surgery alone (patients who had no Postoperative Chemotherapy)

Exclusion criteria

Exclusion criteria: (1)Patients who have previously the preoperative chemotherapy, immunotherapy or radiation therapy. (2)Patients with appendix cancer (3)Patients with history of a malignant tumor (4)Patients with Familial Adenomatous Polyposis

Design outcomes

Primary

Measure	Time frame
To consider the relationship between RS calculated by Oncotype DX Colon Cancer Assay in stage II and stage III colon cancer cases, and RFI* in Japanese.	—

Secondary

Measure	Time frame
To classify patients into the low risk, the intermediate risk, and the high risk according to RS, and test the hypothesis that the risk of recurrence of the patients of the high risk group is significantly high, compared with the patients of the low risk group. To examine the prognosis factor (RFS, DFS and OS) using the cohort on step 1. Relationship between RS and the risk of recurrence in a clinicopathologic factor. Relationship between RS and Alternative Clinical Endpoints. Relationship between Individual Genes, Gene groups, and Recurrence Risk.	—

Measure

Time frame

To classify patients into the low risk, the intermediate risk, and the high risk according to RS, and test the hypothesis that the risk of recurrence of the patients of the high risk group is significantly high, compared with the patients of the low risk group. To examine the prognosis factor (RFS, DFS and OS) using the cohort on step 1. Relationship between RS and the risk of recurrence in a clinicopathologic factor. Relationship between RS and Alternative Clinical Endpoints. Relationship between Individual Genes, Gene groups, and Recurrence Risk.

—

Countries

Japan

Contacts

Public ContactMitsuko MOURI

Japan Clinical Research Support Unit Coodinate Devision

sunrise@crsu.org03-3254-8028

Outcome results