Colon Cancer Prognosis After Radical Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Haraldsplass Deaconess Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Haraldsplass Deaconess Hospital
Information provided by:
Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier:
NCT00963352
First received: August 19, 2009
Last updated: August 26, 2010
Last verified: August 2010
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Purpose
- 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.
- 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).
- 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).
- 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.
- Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.
| Condition |
|---|
|
Colon Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery |
Resource links provided by NLM:
Further study details as provided by Haraldsplass Deaconess Hospital:
Primary Outcome Measures:
- 3-year disease free survival (DFS) [ Time Frame: 2007/10 - 2010/13 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 5-year overall survival (OS) [ Time Frame: 2007/10 - 2012/15 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Biopsies. 1) fresh frozen 2) sampled in RNA later 3) archival formalin
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Patients operated for colon cancer |
Detailed Description:
- 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.
- 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.
- 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).
- 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.
- 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.
Eligibility| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | August 19, 2009 |
| Last Updated: | August 26, 2010 |
| Health Authority: | Norway: Data Protection Authority Norway: Directorate of Health Norway: Ethics Committee Norway: Norwegian Social Science Data Services Norway:National Committee for Medical and Health Research Ethics |
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 |
ClinicalTrials.gov processed this record on May 19, 2013