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

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ClinicalTrials.gov Identifier: NCT02002299
Recruitment Status : Unknown
Verified July 2013 by Zealand University Hospital.
Recruitment status was:  Recruiting
First Posted : December 5, 2013
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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.

Condition or disease
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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Prospective Study of Colorectal Cancer Comparing the Surface With the Invasive Front
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. invasive front growth pattern [ Time Frame: The histopathological study for one specimens takes one week at average, results will be published shortly after july 2014 (one year after start) ]

    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).



Biospecimen Retention:   Samples Without DNA
Surgical resection specimens of colorectal cancers


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients from Roskilde Hopsital with colorectal cancer who is having surgical resection of the tumor
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002299


Contacts
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Contact: Susanne Eiholm, MD +4547325943 seh@regionsjaelland.dk
Contact: Henrik Ovesen, MD +4547323004 henr@reigonsjaelland.dk

Locations
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Denmark
Department of Pathology, Recruiting
Roskilde, Denmark, 4000
Contact: Susanne Eiholm, MD    +4547325943    seh@regionsjaelland.dk   
Contact: Henrik Ovesen, MD    +4547323004    henr@regionsjaelland.dk   
Principal Investigator: Susanne Eiholm, MD         
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Susanne Eiholm, MD Department of Pathology, Roskilde Hospital, Denmark

Additional Information:

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02002299     History of Changes
Other Study ID Numbers: CRCtopfront1
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: July 2013

Keywords provided by Zealand University Hospital:
colorectal cancer
surface
invasive front
tumor budding

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases