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Completed

NCT Number: NCT02727894

Colorectal Cancer: Screening vs. Non-Screening

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Screening

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

About this study

Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee.

All participants gave their informed signed consent. Each centre was assigned a unique ID number to distinguish between the locations in which patients were enrolled.

Patients informations were stored under identification number in secure internet database (RedCap) run by The International Clinical Research Center of St. Anne's University Hospital Brno.REDCap is a secure, web-based application designed to support data capture for research studies.

Statistical analysis was done with SAS, ver. 9.3. Descriptive statistics such as absolute and relative frequencies and median with 95 % confidence intervals were used. Differences between the screening and non-screening groups were compared using the Chi-square test or Fisher's exact test (categorical parameters) and Mann-Whitney test (continuous parameters). Results with a p-value < 0.05 were considered statistically significant

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly diagnosed colorectal cancer

Exclusion criteria

  • unsigned informed consent
  • mental disorder

Treatment and study plan

Primary outcomes

  1. Colorectal Cancer Stage (pTNM)

    Time frame: at time of diagnosis

    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

Secondary outcomes

  1. Colorectal Cancer Grade

    Time frame: after surgery was performed

    Differences between colorectal cancer grade in screening vs. non-screening group.

    • GX (cannot be identified)
    • G1 (well diff.)
    • G2 (moderately diff.)
    • G3 (poorly diff.)
    • G4 (undifferentiated)

    Grades 1,2 were considered to have connection with lower stage

  2. Colorectal Cancer Resection Margins

    Time frame: after surgery was performed

    Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.

    • RX: cannot be identified
    • R0: no cancer cells seen microscopically at the resection margin
    • R1: cancer cells present microscopically at the resection margin (microscopic positive margin)
    • R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)

  3. Colorectal Cancer Metastasis

    Time frame: at time of diagnosis

    Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.

    • MX: cannot be measured
    • M0: cancer has not spread to other parts of the body
    • M1: cancer has spread to other parts of the body

  4. Colorectal Cancer Surgery

    Time frame: time between diagnosis and surgery, measured after surgery was performed

    Median time between diagnosis and surgery.

  5. Colorectal Cancer and Palliative Therapy

    Time frame: during treatment plan setting

    Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group.

    Number of patients treated with palliative therapy in both groups.

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

  • Brno University Hospital
  • Chomutov Hospital
  • Frýdek-Místek Hospital
  • Klaudian Hospital Mladá Boleslav
  • Masaryk Hospital Usti nad Labem
  • Medic Kral Ltd.
  • Military University Hospital, Prague
  • Private practice at Hluboká nad Vltavou
  • The University Hospital Plzeň
  • Tomas Bata Hospital, Czech Republic
  • Vitkovice Hospital

Registry information

Official study title

Colorectal Cancer Screening Detects Tumors at Earlier Stages Improving Clinical Outcomes

Acronym: CRC

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Apr 5, 2016
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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