Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    AgElon
Previous Study | Return to List | Next Study

Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer (AgElOn)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02807129
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 21, 2016
Last Update Posted Date October 25, 2019
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2016)
elastin peptides quantification [ Time Frame: up to 36 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Official Title  ICMJE Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Brief Summary

The aim of the study is to evaluate frailty in patients aged ≥ 65 years with cancer. The elderly population is very heterogeneous, it is necessary to evaluate these elderly patients before treatment to assess the risk-benefit balance. To date, this assessment relies on subjective clinical methods often not optimal, and slow to implement. An innovative method of evaluation could be the determination of elastin peptides. Indeed, the rate of these peptides, which are linked to serious conditions associated with age, rising inexorably with age and dose could help determine more objectively the type of treatment to offer older patients.

Expected results : This study will allow better identification of the group of frail elderly through more relevant biological marker that clinical assessment, often subjective and not available within a period compatible with the treatment of newly diagnosed cancer. This biological assessment will also enable optimal management of elderly patients in particular by allowing the geriatrician better efficiency.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer
Intervention  ICMJE
  • Biological: blood withdrawn
  • Biological: urine collection
Study Arms  ICMJE Experimental: patients
Interventions:
  • Biological: blood withdrawn
  • Biological: urine collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 65 years or older
  • diagnosis of cancer
  • affiliation to a social security scheme
  • Signed informed consent for the study and for the collection of biological samples

Exclusion Criteria:

  • Patient protected by law (guardianship, trusteeship)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rachid MAHMOUDI 326784424 ext 33 rmahmoudi@chu-reims.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02807129
Other Study ID Numbers  ICMJE PO12140
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Reims
Study Sponsor  ICMJE CHU de Reims
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account CHU de Reims
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP