NCT06115837

Brief Summary

The purpose of this study was to identify the prognostic factors of affecting pT4bN0M0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

15 days

First QC Date

October 30, 2023

Last Update Submit

October 30, 2023

Conditions

Keywords

Colorectal CancerMultivisceral resectionPrognosis

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Overall survival is defined as the time from the surgery to death or last follow-up, regardless of disease recurrence, which was measured in months.

    The endpoint of the overall survival assessment is the last follow-up or patient death. Follow-up time is up to 72 months.

  • Cancer specific survival

    Cancer specific survival is defined as the time from the diagnosis to death due to cancer progression, which was measured in months.

    The endpoint of the cancer specific survival assessment is the patient death due to cancer. Follow-up time is up to 72 months.

Interventions

The prognostic factors were analyzed for pT4bN0M0 colorectal cancer after multivisceral resection

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patient experienced multivisceral resection for pT4bN0M0 colorectal cancer from January 2010 to December 2021.

You may qualify if:

  • The patient was pathologically diagnosed as colorectal adenocarcinoma.
  • Patients with pT4bN0M0 colorectal cancer.
  • Patients with R0 resection.

You may not qualify if:

  • Patients with distant metastasis.
  • Patients with R1 or R2 resection.
  • Patients with lymph node metastasis
  • Recurrent colorectal cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (1)

  • Quan J, Zuo K, Li G, Liu J, Mei S, Hu G, Qiu W, Zhuang M, Meng L, Wang X, Chang H, Tang J. Prognostic stratification of patients with pT4bN0M0 colorectal cancer following multivisceral resection: a multi-institutional case series analysis. Int J Surg. 2024 Sep 1;110(9):5323-5333. doi: 10.1097/JS9.0000000000001646.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

September 1, 2023

Primary Completion

September 16, 2023

Study Completion

September 26, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations