NCT03794193

Brief Summary

To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4.9 years

First QC Date

September 9, 2018

Last Update Submit

April 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3-year Disease-free Survival

    The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.

    Within 3 years after surgery

Secondary Outcomes (5)

  • 3-year Over-all Survival

    Within 3 years after surgery

  • Postoperative complication rate

    Within 30 days after surgery

  • Postoperative mortality rate

    Within 30 days after surgery

  • Local recurrence rate

    Within 3 years after surgery

  • Distant organ metastasis rate

    Within 3 years after surgery

Interventions

The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.

Also known as: Chemotherapy

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Colon cancer patients with or without unfavorable histological features

You may qualify if:

  • Age: 18-100 years old;
  • Postoperative pathology confirmed colon adenocarcinoma;
  • The tumor is located from the cecum to the sigmoid colon;
  • No distant organ metastasis;

You may not qualify if:

  • Simultaneous or metachronous multiple primary colorectal cancer;
  • History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)
  • local excision procedure;
  • palliative resection (R2 resection);
  • pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li K, Zhao F, Guo Y, Wu Q, Luo S, Zhang J, Li H, Hu S, Wu B, Lin G, Qiu H, Niu B, Sun X, Xu L, Lu J, Du X, Wang Z, Wang X, Kang L, Wang Z, Wang Q, Liu Q, Xiao Y. Interaction analysis of high-risk pathological features on adjuvant chemotherapy survival benefit in stage II colon cancer patients: a multi-center, retrospective study. BMC Cancer. 2023 Sep 18;23(1):797. doi: 10.1186/s12885-023-11196-4.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yi Xiao, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2018

First Posted

January 4, 2019

Study Start

January 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2023

Last Updated

May 4, 2022

Record last verified: 2022-04