Does Surface Tell us About the Invasive Front in Colorectal Cancer

Colorectal Cancer Clinical Trial

— CRC1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02002299
• Other study ID #: CRCtopfront1
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2013
• Last updated: November 29, 2013
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2013
• Source: Roskilde County Hospital
• Contact: Susanne Eiholm, MD
• Phone: +4547325943
• Email: seh[@]regionsjaelland.dk
• Is FDA regulated: No
• Health authority: Denmark: Roskilde County Hospital, Department of PathologyDenmark: Rodkilde County Hospital, Department of Surgery
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Denmark	Department of Pathology,	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No