Skip to content

Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer

Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer - Validation study of the recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation in StageII/III colon cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000023879
Enrollment
1000
Registered
2016-09-01
Start date
2016-06-01
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

Sponsors

National Defense Medical College and Kyushu University
Lead Sponsor

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), from 2009 to 2012. (2) Patients aged 20- 79 years. (3) Patients who were histologically diagnosed with primary Stage II colon adenocarcinoma and did not receive adjuvant chemotherapy, and patients who were histologically diagnosed with primary Stage III colon adenocarcinoma and received adjuvant chemotherapy.

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. (3) Patients who had recurrence or died within 60 days of surgery.

Design outcomes

Primary

MeasureTime frame
To examine the relationship between recurrence risk stratification using 55-gene classifier (55GC) and RAS mutation, and recurrence-free, disease-free or overall survival in stage II and stage III colon cancer cases.

Secondary

MeasureTime frame
To examine the significance of clinicopathological factors, gene mutations, and multiplex genomic tests as predictors of colon cancer recurrence risk. To investigate the novelty and independence of the 55-gene classifier and RAS family mutation as a risk factor. To examine whether novel procedures can evaluate the effect of oxaliplatin-based adjuvant chemotherapy.

Countries

Japan

Contacts

Public ContactEiji SHINTO

National Defense Medical College Department of Surgery

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026