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

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904955
• Other study ID #: Faivre PHRC K 2010
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: December 10, 2014
• Start date: September 2010

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 598
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	data concerning evolving relapse	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).	during the 10 years following resection for colorectal cancer with curative intent	No