NCT02727894

Brief Summary

The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after immunochemical based faecal occult blood test) has more favourable clinical-pathological characteristics than colorectal cancer diagnosed for symptoms. We aimed to compare these two groups of patients at the time of diagnosis and confirm the efficiency of the screening programme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

March 5, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

March 30, 2016

Results QC Date

August 19, 2017

Last Update Submit

March 3, 2019

Conditions

Colorectal CancerScreening

Keywords

ScreeningpTNMMetastasisChemotherapyResection MarginsColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Colorectal Cancer Stage (pTNM)

    Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group. * 0\. stage (Tis N0 M0) * I. stage (T1-2 N0 M0) * II. stage (T3-4 N0 M0) * III. stage (T1-4 N1-2 M0) * IV. stage (T1-4 N1-2 M1) Stages 0,I II were considered to have better outcome

    at time of diagnosis

Secondary Outcomes (5)

  • Colorectal Cancer Grade

    after surgery was performed

  • Colorectal Cancer Resection Margins

    after surgery was performed

  • Colorectal Cancer Metastasis

    at time of diagnosis

  • Colorectal Cancer Surgery

    time between diagnosis and surgery, measured after surgery was performed

  • Colorectal Cancer and Palliative Therapy

    during treatment plan setting

Study Arms (2)

Screening Group

CRC diagnosed by screening was defined as cancer diagnosed by primary screening colonoscopy, or colonoscopy after a positive immunochemical based faecal occult blood test i(FOBT) in patients without symptoms invited to examination according to the national screening programme policy

Non-screening Group

Symptomatic CRC was defined as cancer diagnosed in symptomatic patients.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinics, university hospitals, private practices

You may qualify if:

  • newly diagnosed colorectal cancer

You may not qualify if:

  • unsigned informed consent
  • mental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisMargins of Excision

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsMorphological and Microscopic Findings

Results Point of Contact

Title
Jan Král
Organization
Institution for Clinical and Experimental Medicine
jan.kral@centrum.cz
+420605273008

Study Officials

  • Jan Král, M.D.

    Institute for Clinical and Experimental Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 30, 2016

First Posted

April 5, 2016

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

March 5, 2019

Results First Posted

March 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)