Does Surface Tell us About the Invasive Front in Colorectal Cancer (CRC1)

Prospective Study of Colorectal Cancer Comparing the Surface With the Invasive Front

The purpose of this study is to investigate the invasive front in growth mode (expanding or infiltrative) and dedifferentiation (tumor budding) and comparing these with the tumor surface (polypose or flat) + / - ulceration in surgical specimens at colorectal cancer.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

Detailed Description

Timetable: From 1 August 2013 to 31 July 2014.

Organisational arrangements: The project is deleted from the pathology department, Roskilde Hospital, and surgical department, Roskilde Hospital.

inclusion criteria All colorectal surgical specimens having cancer were the patient did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation.

Microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma.

When the specimens is received at the department of pathology and is included in the study the pathologist report is registered in a local database.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Recruiting
    • Department of Pathology,
    • Contact: Susanne Eiholm, MD; Phone Number: +4547325943; Email: seh@regionsjaelland.dk
    • Contact: Henrik Ovesen, MD; Phone Number: +4547323004; Email: henr@regionsjaelland.dk
    • Principal Investigator: Susanne Eiholm, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients from Roskilde Hopsital with colorectal cancer who is having surgical resection of the tumor

Description

Inclusion Criteria:

• All surgical preparations from patients with colorectal cancer that did not receive neoadjuvant treatment received in the pathology department in accordance with current guidelines with the cutting of the tumor area in parallel slices and photographed, so there is macroscopic photo documentation.

Microscopic tumors classified as adenocarcinoma of glandular type, mucinous adenocarcinoma, signet ring cell carcinoma.

Exclusion Criteria:

• All surgical preparations from patients with colorectal cancer where the patient received neoadjuvant therapy or when surgery preparation could not be received by current guidelines and all preparations where it is not possible to obtain macroscopic image of the parallel slices.

Microscopic tumors that can not be classified as adenocarcinoma of the glandular type, mucinous adenocarcinoma or signet ring cell carcinoma excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive front growth pattern	Microscopic divided tumors after growth pattern at the invasive front (tumor-bottom), rated on average, there is immunohistochemical stained for pancytokeratin. A points 1-4 described by Franzen et al (2008) used: tumor bottom is regular and smooth (score 1), tumor-bottom is irregular with large cell clusters (score 2), tumor-bottom is irregular with large and small clusters (score 3) and tumor-bottom consists almost entirely of smaller clusters (score 4). It is also noted whether there is a tumor budding or not. Tumor budding is a histological phenomenon that reflect loss of adhesion between tumor cells in the stroma of the invasive front of colorectal cancers. It is present if more than five groups containing 1-4 cancer cells each, within a microscopic area on x20 (Uneo et al (x25), 2002 and Mitrovic et al (x20), 2012).	The histopathological study for one specimens takes one week at average, results will be published shortly after july 2014 (one year after start)

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Susanne Eiholm, MD, Department of Pathology, Roskilde Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: November 29, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: colorectal cancer; surface; invasive front; tumor budding
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CRCtopfront1