NCT05420415

Brief Summary

Colorectal cancer (CRC) is the second most commonly occurring cancer worldwide. Thirty-five percent of CRC patients are diagnosed at stage II/III, and their outcome differs even if they are in the same stage. Previous study found that the microenvironmental collagen is associated with tumor progression and metastasis. Whether tumor microenvironmental collagen signature is associated with colorectal cancer prognosis still remains unknown. We hypothesize that the tumor microenvironmental collagen signature of colorectal cancer is associated with prognosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Typical duration 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, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
Last Updated

June 15, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

June 12, 2022

Last Update Submit

June 12, 2022

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 5-year DFS

    5-year disease free survival

    5 years followup after surgery

Secondary Outcomes (1)

  • 5-year OS

    5 years followup after surgery

Study Arms (2)

High-CSTME

Patients with high tumor microenvironment collagen signature

Other: CSTME

Low-CSTME

Patients with low tumor microenvironment collagen signature

Interventions

CSTMEOTHER

Tumor microenvironment collagen signature

High-CSTME

Eligibility Criteria

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

Patients diagnosed with stageII/III colorectal cancer

You may qualify if:

  • Pathologically diagnosed with colorectal cancer
  • TNM stages II and III (according to the 8th edition of AJCC Cancer Staging Manual)
  • Received radical tumor resection surgery

You may not qualify if:

  • ASA grade 4
  • Preoperative radiotherapy and/or chemotherapy
  • Hereditary colorectal cancer
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

paraffin tissue section

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jun Yan, MD

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 12, 2022

First Posted

June 15, 2022

Study Start

September 1, 2018

Primary Completion

September 1, 2021

Study Completion

May 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-04

Locations

CN(1)