NCT02807129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
296

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2025

Enrollment Period

9 years

First QC Date

June 16, 2016

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • elastin peptides quantification

    up to 36 months

Study Arms (1)

patients

EXPERIMENTAL
Biological: blood withdrawnBiological: urine collection

Interventions

blood withdrawnBIOLOGICAL
patients
patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient protected by law (guardianship, trusteeship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, 51092, France

Location

Related Publications (1)

  • Salesse S, Odoul L, Chazee L, Garbar C, Duca L, Martiny L, Mahmoudi R, Debelle L. Elastin molecular aging promotes MDA-MB-231 breast cancer cell invasiveness. FEBS Open Bio. 2018 Aug 2;8(9):1395-1404. doi: 10.1002/2211-5463.12455. eCollection 2018 Sep.

    PMID: 30186741BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Urine Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 21, 2016

Study Start

January 29, 2014

Primary Completion

January 16, 2023

Study Completion

January 16, 2023

Last Updated

January 21, 2026

Record last verified: 2025-01

Locations