Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer (AgElOn)
Primary Purpose
Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood withdrawn
urine collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer
Eligibility Criteria
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)
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
Outcomes
Primary Outcome Measures
elastin peptides quantification
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02807129
Brief Title
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Acronym
AgElOn
Official Title
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood withdrawn
Intervention Type
Biological
Intervention Name(s)
urine collection
Primary Outcome Measure Information:
Title
elastin peptides quantification
Time Frame
up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachid MAHMOUDI
Phone
326784424
Ext
33
Email
rmahmoudi@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
France
State/Province
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
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