Does Surface Tell us About the Invasive Front in Colorectal Cancer

NCT02002299 | Unknown

• 1 other identifier: CRCtopfront1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; surface; invasive front; tumor budding

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Pathology,

Roskilde, Roskilde, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgical resection specimens of colorectal cancers

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Susanne Eiholm, MD

  Department of Pathology, Roskilde Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Eiholm, MD

CONTACT

+4547325943; seh@regionsjaelland.dk

Henrik Ovesen, MD

CONTACT

+4547323004; henr@reigonsjaelland.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: December 5, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 5, 2013

Record last verified: 2013-07

Locations

DK (1)