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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:
Haraldsplass Deaconess Hospital

Tracking Information
First Submitted Date August 19, 2009
First Posted Date August 21, 2009
Last Update Posted Date August 27, 2010
Study Start Date January 2007
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2009)
3-year disease free survival (DFS) [ Time Frame: 2007/10 - 2010/13 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 20, 2009)
5-year overall survival (OS) [ Time Frame: 2007/10 - 2012/15 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Colon Cancer Prognosis After Radical Surgery
Official Title Prognosis of Colon Cancer. Clinical and Pathological-anatomical Factors Concerned With Radical Surgery
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.
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biopsies. 1) fresh frozen 2) sampled in RNA later 3) archival formalin
Sampling Method Non-Probability Sample
Study Population Community patient population from hospital catchment area.
Condition Colon Cancer
Intervention Not Provided
Study Groups/Cohorts Patients operated for colon cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 20, 2009)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT00963352
Other Study ID Numbers Knut2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karl Sondenaa, professor, University of Bergen, Haraldsplass Deaconal Hospital, Department of Surgery, Bergen, Norway
Study Sponsor Haraldsplass Deaconess Hospital
Collaborators Not Provided
Investigators
Study Chair: Karl Sondenaa, MD, PhD Haraldsplass Deaconal Hospital, University of Bergen, Norway
PRS Account Haraldsplass Deaconess Hospital
Verification Date August 2010