A Clinico-biological Database in Cachexia in Patients With Colon Cancer

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

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-23

Study Completion Date

2029-05-31

Brief Summary

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

Creation of a prospective clinico-biological database dedicated to cachexia and undernutrition in order to carry out future research projects, to improve our knowledge of colon cancer and cachexia and to optimize the therapeutic management of patients

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Development of Clinical and Biological Database in Colorectal Cancer

NCT04186117

Metastatic Colon Cancer

COMPLETED NA

Clinical and Biological Database in Colon Cancer and Colic Tumors

NCT03976960

Cancer Colon

RECRUITING NA

Tumoral Circulating Cells and Colorectal Cancer Progression

NCT03256084

Colorectal Cancer

UNKNOWN NA

Determining Energy Needs in Colorectal Cancer

NCT03131921

Colorectal Cancer

COMPLETED

Circulating Tumor Cells and Neutrophils Count for Colorectal Metastatic Cancer

NCT05793775

Metastatic Colorectal Cancer

COMPLETED

Detailed Description

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

Patients with cancers, and in particular colorectal cancers, very often present profound nutritional and/or metabolic alterations, the most spectacular being cachexia. Cachexia is a morbid syndrome characterized by rapid involuntary weight loss mainly affecting the storage tissues of adipose tissue and skeletal muscle. This global metabolic syndrome is a major contributory factor and sometimes causative factor in the failure of treatments and the death of patients. Although a major public health problem, this disease is poorly understood and for which there are no reliable biomarkers and no universally accepted treatment protocol. It therefore appears essential to better understand this disease in order to improve the well-being and survival of patients. Being a disease with a strong metabolic component, the integration of nutritional approaches is essential. Many advances have been made in recent years in the field of clinical nutrition, particularly in cancer cachexia. Clinical nutrition is a new, transversal, booming specialty.

Recent publications suggests that cancer patients, overweight or obese, may present muscle depletion, an independent predictor of overall survival. Recent results suggest that muscle atrophy is associated with more severe toxicity of anti-cancer treatments such as fluoropyrimidines, anthracyclines, combination chemotherapy, sunitinib and sorafenib. Muscle wasting is a predictive factor for therapeutic dose limitation: dose reduction, delay or definitive discontinuation of treatment. The majority of anti-cancer drugs have a limited therapeutic index. It is important to determine the factors that explain the individual variations in efficacy and toxicity, and the determination of body composition for each patient is therefore an important step in the nutritional evaluation process, and essential data for this data base.

The investigators therefore propose the development of a prospective clinico-biological database for cachexia in patients with colon cancer, can be used for research projects aimed at developing tailored patient management strategies.

Conditions

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

Colon Cancer

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Biological collection

For all patients included in the study:

* Blood samples collected at different times: at inclusion and during treatment every 6 months
* In parallel to this biological collection, standardized clinical data will be entered into a database

Group Type EXPERIMENTAL

Biological collection

Intervention Type BIOLOGICAL

\- Blood samples collected at different times: at inclusion and during treatment ( every 6 month)

Interventions

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

Biological collection

\- Blood samples collected at different times: at inclusion and during treatment ( every 6 month)

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

1. Age ≥ 18 years old,
2. Patient treated at the Montpellier Regional Cancer Institute for colon cancer not eligible for surgery (of the primary tumor or associated metastases), whether undergoing treatment or not,
3. Patient requiring treatment for colon cancer (chemotherapy, targeted therapy, etc.),
4. Patient having accepted the constraints of the research and the blood samples planned for the research
5. Patient affiliated to Social Protection system
6. Informed consent form signed

Exclusion Criteria

1. Patient requiring surgery (for treatment of colon cancer or metastasis)
2. Patient with exclusive peritoneal carcinomatosis
3. Patient requiring radiotherapy
4. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
5. Pregnant and/ or breastfeeding women
6. Patient cared for an emergency context

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No