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Colon Cancer Prognosis After Radical Surgery

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ClinicalTrials.gov Identifier: NCT00963352
Recruitment Status : Unknown
Verified August 2010 by Haraldsplass Deaconess Hospital.
Recruitment status was:  Recruiting
First Posted : August 21, 2009
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
  1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen.
  2. Markers. There may be variables that may make patient assessment more sound. The project is including investigation of such markers (genes, old age, comorbidity, and others).
  3. Laparoscopic resections. This is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. The project compares these according to 1) and 2).
  4. Morbidity and mortality must be surveilled to keep at a minimum. Many patients have comorbidity and are old to make this factor extra important, including perioperative care.
  5. Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.

Condition or disease
Colon Cancer

Detailed Description:
  1. Radical surgery. A detailed description of procedures for each location of tumor in the large intestine is used. By following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site.
  2. Markers. Different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior.
  3. Laparoscopic resections. The technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. However, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality).
  4. Comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. A maximum 3% mortality should be aimed for.
  5. Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver metastases has been extensively studied and the prognosis has improved. Lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. The need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery
Study Start Date : January 2007
Primary Completion Date : August 2009
Estimated Study Completion Date : December 2010
Groups and Cohorts

Group/Cohort
Patients operated for colon cancer


Outcome Measures

Primary Outcome Measures :
  1. 3-year disease free survival (DFS) [ Time Frame: 2007/10 - 2010/13 ]

Secondary Outcome Measures :
  1. 5-year overall survival (OS) [ Time Frame: 2007/10 - 2012/15 ]

Biospecimen Retention:   Samples With DNA
Biopsies. 1) fresh frozen 2) sampled in RNA later 3) archival formalin

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community patient population from hospital catchment area.
Criteria

Inclusion Criteria:

  • Malignant tumor (adenocarcinoma) of the large intestine (colon)
  • Willingness to participate

Exclusion Criteria:

  • No radical resection (R0) possible
  • Unwilling to participate or medically unfit to undergo follow-up
Contacts and Locations

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): NCT00963352


Contacts
Contact: Karl Sondenaa, MD, PhD +47-91868877 kasoende@online.no
Contact: Rune Haaverstad, MD, PhD +47-92210911 rune.haaverstad@helse-bergen.no

Locations
Norway
Haraldsplass Deaconal Hospital, Department of Surgery Recruiting
Bergen, Norway, 5009
Contact: Karl Sondenaa, MD, PhD    +47-91868877    kasoende@online.no   
Contact: Kristian E. Storli, MD    +47-55978665    kstoris@hotmail.com   
Principal Investigator: Kristian E. Storli, MD         
Principal Investigator: Bjarte Hjelmeland, MD         
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Rune Haaverstad, MD, PhD       rune.haaverstad@helse-bergen.no   
Principal Investigator: Bjarte Hjelmeland, MD         
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
Investigators
Study Chair: Karl Sondenaa, MD, PhD Haraldsplass Deaconal Hospital, University of Bergen, Norway
More Information

Responsible Party: Karl Sondenaa, professor, University of Bergen, Haraldsplass Deaconal Hospital, Department of Surgery, Bergen, Norway
ClinicalTrials.gov Identifier: NCT00963352     History of Changes
Other Study ID Numbers: Knut2009
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by Haraldsplass Deaconess Hospital:
Colon cancer
Open surgery resection
Laparoscopic surgery resection
Morbidity
Mortality
Metastases
Oncology
Freedom of malignant disease recurrence
Safety of intervention open and laparoscopic
Examination of adverse markers
Development of metastases in lungs and other organs

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