Colorectal CancerCRC1NCT02002299
Does Surface Tell us About the Invasive Front in Colorectal Cancer
An observational study of Colorectal Cancer, run by Zealand University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2013to Aug 2014
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients from Roskilde Hopsital with colorectal cancer who is having surgical resection of the tumor
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Pathology,
Roskilde, Roskilde, 4000
Susanne Eiholm, MD, +4547325943, seh@regionsjaelland.dk
Henrik Ovesen, MD, +4547323004, henr@regionsjaelland.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, surface, invasive front, tumor budding
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The histopathological study for one specimens takes one week at average, results will be published shortly after july 2014 (one year after start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Eiholm, MD, Principal investigator, Department of Pathology, Roskilde Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002299
- Sponsor's protocol ID
- CRCtopfront1
- Acronym
- CRC1
- Status last verified
- Jul 2013
- First submitted
- 2 Aug 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Colorectal Cancer Comparing the Surface With the Invasive Front
- ClinicalTrials.gov ID
- NCT02002299
- Acronym / sponsor ID
- CRC1 / CRCtopfront1
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, surface, invasive front, tumor budding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 5 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients from Roskilde Hopsital with colorectal cancer who is having surgical resection of the tumor
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Eiholm, MD principal investigator
Department of Pathology, Roskilde Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Eiholm, MD (+4547325943, seh@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013; AzTrials last refreshed its copy on 2 Nov 2026.