A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer

A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer - A study to determine a correction coefficient for the introduction of 55-gene classifier (55GC) into clinical practice, aimed at predicting the recurrence risk in Stage II/III colon cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000024159

Enrollment

200

Registered

2016-09-30

Start date

2016-07-01

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 underwent curative resection (R0) of stage II or stage III colon cancer (including rectosigmoid cancer), with lymph node dissection (D2 or D3), during the period between the date of approval and 2018. (2) Patients aged 20-79 years. (3) Patients who were histologically diagnosed with primary Stage II colon adenocarcinoma, and patients who were histologically diagnosed with primary Stage III colon adenocarcinoma.

Exclusion criteria

Exclusion criteria: (1) Patients who had received preoperative therapy. (2) Patients with a previous malignancy, within 5 years of operation, except for tumors at the stage of carcinoma in situ.

Design outcomes

Primary

Measure	Time frame
To examine the mean expression levels of each gene that comprises 55-gene classifier together with the standard deviation.	—

Secondary

Measure	Time frame
To examine differences between the determined correlation coefficient and that calculated from the cohorts of a retrospective multi-site observational study of 55-gene classifier that will be conducted separately.	—

Countries

Japan

Contacts

Public ContactEiji SHINTO

National Defense Medical College Department of Surgery

eiji-c@zf6.so-net.ne.jp04-2995-1637

Outcome results