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A Clinico-biological Database in Cachexia in Patients With Colon Cancer (BCB Cachexie)

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Régional du cancer de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological collection

Arm Description

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

Outcomes

Primary Outcome Measures

Number of clinical risk factors for colorectal cancer
Number of biological risk factors for colorectal cancer

Secondary Outcome Measures

Full Information

First Posted
February 16, 2022
Last Updated
March 11, 2022
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT05257135
Brief Title
A Clinico-biological Database in Cachexia in Patients With Colon Cancer
Acronym
BCB Cachexie
Official Title
Development of a Prospective Clinico-biological Database in Cachexia in Patients With Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological collection
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Biological collection
Intervention Description
- Blood samples collected at different times: at inclusion and during treatment ( every 6 month)
Primary Outcome Measure Information:
Title
Number of clinical risk factors for colorectal cancer
Time Frame
Until the study completion : 6 years
Title
Number of biological risk factors for colorectal cancer
Time Frame
Until the study completion : 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Pierre Bleuse, MD
Phone
4 67 61 31 02
Ext
+33
Email
DRCI-icm105@icm.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurore Moussion
Phone
4 67 61 24 46
Ext
+33
Email
DRCI-icm105@icm.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Senesse, MD
Organizational Affiliation
Institut régional du cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Régional du cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Senesse, M.D
Phone
4 67 61 85 54
Ext
+33
Email
pierre.senesse@icm.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23107793
Citation
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.
Results Reference
result
PubMed Identifier
21986910
Citation
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.
Results Reference
result
PubMed Identifier
23530101
Citation
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.
Results Reference
result
PubMed Identifier
17545532
Citation
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.
Results Reference
result
PubMed Identifier
23966429
Citation
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.
Results Reference
result
PubMed Identifier
20089558
Citation
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.
Results Reference
result
PubMed Identifier
20164322
Citation
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.
Results Reference
result

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

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