AGARIC Case Control Study

NCT ID: NCT01966081

Last Updated: 2013-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

576 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

First Recently-diagnosed Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

Group Type OTHER

Blood sample

Intervention Type OTHER

tissue samples from abdominal subcutaneous adipose

Intervention Type OTHER

controls

Group Type OTHER

Blood sample

Intervention Type OTHER

tissue samples from abdominal subcutaneous adipose

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood sample

Intervention Type OTHER

tissue samples from abdominal subcutaneous adipose

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Jean Minjoz

Besançon, , France

Site Status RECRUITING

CHU Dijon

Dijon, , France

Site Status RECRUITING

Hôpital Robert Debré

Reims, , France

Site Status RECRUITING

Hôpital Hautepierre

Strasbourg, , France

Site Status RECRUITING

Hôpital de BRABOIS

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Claire BONITHON-KOPP

Role: CONTACT

Phone: 3 80 39 33 37

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Georges MANTION

Role: primary

Patrick RAT

Role: primary

Jean-François DELATTRE

Role: primary

Serge ROHR

Role: primary

Laurent BRESLER

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Cottet V, Vaysse C, Scherrer ML, Ortega-Deballon P, Lakkis Z, Delhorme JB, Deguelte-Lardiere S, Combe N, Bonithon-Kopp C. Fatty acid composition of adipose tissue and colorectal cancer: a case-control study. Am J Clin Nutr. 2015 Jan;101(1):192-201. doi: 10.3945/ajcn.114.088948. Epub 2014 Nov 12.

Reference Type DERIVED
PMID: 25527763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bonithon hors AOI 2008

Identifier Type: -

Identifier Source: org_study_id