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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blood withdrawn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
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer

Eligibility Criteria

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

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

First Posted
June 16, 2016
Last Updated
October 24, 2019
Sponsor
CHU de Reims
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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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