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Should Colorectal Cancer Patients be Followed After Five Years? Study of Recurrence in a Population Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904955
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

The results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative intent, so as to improve management and thus improve patient survival.

These data will also make it possible to calculate the prevalence of patients who require treatment or surveillance because of their disease.


Condition or disease
Colorectal Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 598 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Study Start Date : September 2010
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. data concerning evolving relapse [ Time Frame: during the 10 years following resection for colorectal cancer with curative intent ]
    • the date of recurrence
    • the site
    • the finality of the surgical treatment (resection with curative intent defined as macroscopically complete resection, without involvement of the surgical margin in the histological examination)
    • the non-surgical adjuvant or palliative treatments (radiotherapy, chemotherapy).



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:   Probability Sample
Study Population
patients with adenocarcinoma of the colon or rectum
Criteria

Inclusion Criteria:

  • with adenocarcinoma of the colon or rectum (ICD-O: C18, C19 and C20)
  • residing in the département of Côte-d'Or (501,000 inhabitants according to the 1999 census) or Calvados (511, 012 inhabitants) at the moment of diagnosis
  • recorded by either Registry between January 1985 and December 2000
  • treated by resection with a curative intent.

Exclusion Criteria:

Will be excluded other morphologic tumours and initially metastatic colorectal cancers, anal cancers.


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): NCT01904955


Locations
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France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
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Principal Investigator: FAIVRE Jean CHU Dijon Gastroentérologie
Additional Information:

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01904955    
Other Study ID Numbers: Faivre PHRC K 2010
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: July 2013
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