A Clinico-biological Database in Cachexia in Patients With Colon Cancer
BCBCachexie
Development of a Prospective Clinico-biological Database in Cachexia in Patients With Colon Cancer
1 other identifier
interventional
150
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
ExpectedFebruary 13, 2025
February 1, 2025
4.4 years
February 16, 2022
February 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of clinical risk factors for colorectal cancer
Until the study completion : 6 years
Number of biological risk factors for colorectal cancer
Until the study completion : 6 years
Study Arms (1)
Biological collection
EXPERIMENTALFor 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
Interventions
\- Blood samples collected at different times: at inclusion and during treatment ( every 6 month)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Régional du cancer de Montpellier
Montpellier, 34298, France
Related Publications (7)
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.
PMID: 23107793RESULTMacDonald 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.
PMID: 21986910RESULTMartin 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.
PMID: 23530101RESULTPrado 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.
PMID: 17545532RESULTPrado 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.
PMID: 23966429RESULTAntoun 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.
PMID: 20089558RESULTBaracos 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.
PMID: 20164322RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pierre Senesse, MD
Institut régional du cancer de Montpellier
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
December 23, 2021
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2029
Last Updated
February 13, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share