AGARIC Case Control Study

Not Applicable

• Conditions: First Recently-diagnosed Colorectal Cancer
• Interventions: Other: Blood sample; Other: tissue samples from abdominal subcutaneous adipose

• Registration Number: NCT01966081
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

The aim of the study is to establish the existence of a relationship between the dietary intake of polyunsaturated fatty acids (PUFA) and the risk of colorectal cancer in humans, using 2 reliable and complementary biomarkers: the fatty acid-composition of lipids of the abdominal subcutaneous adipose tissue and the fatty acid composition of erythrocyte phospholipids.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-10
• Study First Submitted QC: 2013-10-16
• Last Update Submitted: 2013-10-16
• Study First Posted: 2013-10-21
• Last Update Posted: 2013-10-21
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

CASES

• Patients aged ≥ 45 years
• with a first recently-diagnosed colorectal cancer
• due to undergo elective surgical resection with curative intent (in practice, stage I, II, III or IV if there was only one hepatic nodule that was resected with curative intent) in one of the 5 following digestive surgery units: CHU de Dijon, CHU de Nancy, CHU de Strasbourg, CHU de Reims et CHU and Besançon.
• who have given their informed consent

CONTROLS

• Patients aged ≥ 45 years
• due to undergo surgery for a benign abdominal disease (sigmoid diverticulitis, appendectomy, hiatal hernia ...)
• matched for abdominal site with cases for age (± 3 years), sex and hospital
• Who have given their informed consent

Exclusion Criteria

CASES

• pre-operative anticancer treatment (chemo or radiotherapy)
• existence of visceral metastases except a single hepatic nodule resected with curative intent
• familial adenomatous polyposis and HNPCC syndrome (when suspected: inclusion after complementary tumor phenotype study: screening for microsatellite instability and/or immunohistochemistry study of the expression of DNA mismatch repair proteins.
• known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
• personal history (recent or not) of colorectal cancer
• emergency treatment for the presenting complication (perforation, occlusion...)
• significant modification in dietary habits during the previous three months
• other evolving neoplastic disease
• psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
• pregnant or breast-feeding women

CONTROLS

• personal history of cancer or adenomatous colorectal polyps,
• emergency intervention
• known inflammatory disease of the intestine (ulcerative colitis, Crohn's disease)
• personal history (recent or not) of colorectal cancer
• emergency treatment for the presenting complication (perforation, occlusion...)
• significant modification in dietary habits during the previous three months
• evolving neoplastic disease
• psychic state incompatible with understanding the modalities and the aims of the study (notably patients under guardianship)
• pregnant or breast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cases	tissue samples from abdominal subcutaneous adipose	-
controls	Blood sample	-
Cases	Blood sample	-
controls	tissue samples from abdominal subcutaneous adipose	-

Primary Outcome Measures

Name	Time	Method
Measure of polyunsaturated fatty acids in adipose tissue lipids.	baselines

Trial Locations

Locations (5)

Hôpital de BRABOIS; 🇫🇷 Vandoeuvre-les-nancy, France

Hôpital Hautepierre; 🇫🇷 Strasbourg, France

CHU Jean Minjoz; 🇫🇷 Besancon, France

CHU Dijon; 🇫🇷 Dijon, France

Hôpital Robert Debré; 🇫🇷 Reims, France