A prospective observational study on high-risk factors for Stage II colorectal cancer

A prospective observational study on high-risk factors for Stage II colorectal cancer - A prospective observational study on high-risk factors for Stage II colorectal cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053640

Enrollment

3000

Registered

2024-02-18

Start date

2024-03-07

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

pathological stage II colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The histopathological diagnosis of the surgical specimen confirms adenocarcinoma (including papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and medullary carcinoma) according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma. 2) The primary site determined by surgical findings is diagnosed as ranging from the cecum to the rectum or anal canal (C, A, T, D, S, RS, Ra, Rb, P) according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma. 3) R0 resection has been performed. 4) The stage is classified as (y)pStage II according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma. 5) The age at registration is 20 years or older. 6) An adequate explanation of the study has been provided, and written informed consent has been obtained from the participants.

Exclusion criteria

Exclusion criteria: 1) Presence of active double cancer (simultaneous double cancer/multiple primary cancers and metachronous double cancer/multiple primary cancers with a disease-free period of <five years. 2) Colorectal cancer associated with ulcerative colitis or Crohn's disease. 3) Colorectal cancer associated with familial adenomatous polyposis. 4) Some adenocarcinomas contain histological types different from adenocarcinoma (such as squamous cell carcinoma, neuroendocrine carcinoma). 5) Other reasons deemed inappropriate for registration by the attending physician for this study.

Design outcomes

Primary

Measure	Time frame
3-year relapse-free survival	—

Secondary

Measure	Time frame
3-year overall survival, 5-year relapse-free survival, 5-year overall survival	—

Countries

Japan

Contacts

Public ContactTatsuki Noguchi

Cancer Institute Hospital Department of Colorectal Surgery

tatsuki.noguchi@jfcr.or.jp+81335200111

Outcome results