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

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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

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.


Condition or disease Intervention/treatment Phase
Cancer Biological: blood withdrawn Biological: urine collection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fragmentation of Elastin as a Biological Marker of Frailty and Impact in Tumor Progression in Elderly Patients With Cancer
Study Start Date : January 2014
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024


Arm Intervention/treatment
Experimental: patients Biological: blood withdrawn
Biological: urine collection



Primary Outcome Measures :
  1. elastin peptides quantification [ Time Frame: up to 36 months ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807129


Contacts
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Contact: Rachid MAHMOUDI 326784424 ext 33 rmahmoudi@chu-reims.fr

Locations
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France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02807129    
Other Study ID Numbers: PO12140
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Frailty
Pathologic Processes