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Colon CancerBCBCachexieNCT05257135

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

A study testing Biological collection in people with Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colon Cancer
What is being tested?
Biological collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFrance
Study dates
23 Dec 2021to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old,
  • 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,
  • Patient requiring treatment for colon cancer (chemotherapy, targeted therapy, etc.),
  • Patient having accepted the constraints of the research and the blood samples planned for the research
  • Patient affiliated to Social Protection system
  • Informed consent form signed

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Pierre Bleuse, MD contact

4 67 61 31 02 ext. +33

DRCI-icm105@icm.unicancer.fr

Aurore Moussion contact

4 67 61 24 46 ext. +33

DRCI-icm105@icm.unicancer.fr

France1 site, 1 recruiting

  • Institut Régional du cancer de Montpellier

    Montpellier, 34298

    Pierre Senesse, M.D, 4 67 61 85 54 ext. +33, pierre.senesse@icm.unicancer.fr

    Recruiting

Other trials in France

About this study

Official title: Development of a Prospective Clinico-biological Database in Cachexia in Patients With Colon Cancer

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

Read the detailed description

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
Colon Cancer
Being tested
Biological collection
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological collectionBiological

    • Blood samples collected at different times: at inclusion and during treatment ( every 6 month)
Study groups in NCT05257135
Study groupRoleWhat they receive
Biological collectionExperimentalFor 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
Receives: Biological: Biological collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of clinical risk factors for colorectal cancer

    Measured: Until the study completion : 6 years

  2. Number of biological risk factors for colorectal cancer

    Measured: Until the study completion : 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start23 Dec 2021
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257135
Sponsor's protocol ID
PROICM 2019-15-BCA
Acronym
BCBCachexie
Status last verified
Feb 2025
First submitted
16 Feb 2022
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chambrier C, Sztark F; Societe Francophone de nutrition clinique et metabolisme (SFNEP); Societe francaise d'anesthesie et reanimation (SFAR). French clinical guidelines on perioperative nutrition. Update of the 1994 consensus conference on perioperative artificial nutrition for elective surgery in adults. J Visc Surg. 2012 Oct;149(5):e325-36. doi: 10.1016/j.jviscsurg.2012.06.006. Epub 2012 Oct 26.

    PubMed 23107793

  • MacDonald AJ, Greig CA, Baracos V. The advantages and limitations of cross-sectional body composition analysis. Curr Opin Support Palliat Care. 2011 Dec;5(4):342-9. doi: 10.1097/SPC.0b013e32834c49eb.

    PubMed 21986910

  • Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.

    PubMed 23530101

  • Prado CM, Baracos VE, McCargar LJ, Mourtzakis M, Mulder KE, Reiman T, Butts CA, Scarfe AG, Sawyer MB. Body composition as an independent determinant of 5-fluorouracil-based chemotherapy toxicity. Clin Cancer Res. 2007 Jun 1;13(11):3264-8. doi: 10.1158/1078-0432.CCR-06-3067.

    PubMed 17545532

  • Prado CM, Sawyer MB, Ghosh S, Lieffers JR, Esfandiari N, Antoun S, Baracos VE. Central tenet of cancer cachexia therapy: do patients with advanced cancer have exploitable anabolic potential? Am J Clin Nutr. 2013 Oct;98(4):1012-9. doi: 10.3945/ajcn.113.060228. Epub 2013 Aug 21.

    PubMed 23966429

  • Antoun S, Baracos VE, Birdsell L, Escudier B, Sawyer MB. Low body mass index and sarcopenia associated with dose-limiting toxicity of sorafenib in patients with renal cell carcinoma. Ann Oncol. 2010 Aug;21(8):1594-1598. doi: 10.1093/annonc/mdp605. Epub 2010 Jan 20.

    PubMed 20089558

  • Baracos VE, Reiman T, Mourtzakis M, Gioulbasanis I, Antoun S. Body composition in patients with non-small cell lung cancer: a contemporary view of cancer cachexia with the use of computed tomography image analysis. Am J Clin Nutr. 2010 Apr;91(4):1133S-1137S. doi: 10.3945/ajcn.2010.28608C. Epub 2010 Feb 17.

    PubMed 20164322

Questions about this trial

What is this clinical trial studying?

A study testing Biological collection in people with Colon Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Pierre Bleuse, MD (4 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of clinical risk factors for colorectal cancer (time frame: Until the study completion : 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05257135, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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