NCT03299855

Brief Summary

This study concerns elderly patients with cancer with onco-geriatric assessment. This study propose to associate the collection of the results with the Mini-Cog and the CODEX with the passing of the MoCA and the MMS tests, as well as a neuropsychological assessment, in order to determine if the patients have cognitive impairments, to evaluate the sensitivity of these 4 screening tests in elderly patients seeking treatment for their cancer. The results of this study will make it possible, where appropriate, to adapt the practice in the context of oncogeriatric assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

October 13, 2017

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2023

Completed
Last Updated

October 18, 2023

Status Verified

September 1, 2023

Enrollment Period

6 years

First QC Date

September 26, 2017

Last Update Submit

October 17, 2023

Conditions

Keywords

oncogeriatricMMSMoCA

Outcome Measures

Primary Outcomes (1)

  • Evaluate the sensitivity of MoCA test

    MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%

    Up 2 months after inclusion, before initiation of treatment

Interventions

Passation of MoCA and MMS tests associated with neuropsychological test

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient aged over 70 years
  • Patient with cancer (solid tumor or haemopathy) for whom a first line treatment is envisaged (whatever it is). Surgery and radiotherapy are allowed before entry into the study.
  • Patient candidate for oncogeriatric assessment
  • Patient agree to participate in the study
  • Using the French language

You may not qualify if:

  • Primary central nervous system or cerebral metastasis
  • Evolutionary psychiatric pathology known (e.g. schizophrenia)
  • Severe Visual and / or Auditory Impairment
  • Patients unable to respond to cognitive tests
  • Patient (s) deprived of liberty, under guardianship or curatorship
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre François Baclesse

Caen, France

Location

CHU

Caen, France

Location

CH

Cherbourg, France

Location

Ch Compiegne

Compiègne, France

Location

Centre Henri Becquerel

Rouen, France

Location

Centre Hospitalier

Saint-Lô, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • florence JOLY, prof

    Centre François Baclesse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Passation of MMS and MoCA tests associated to passation of neuropsychological test
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2017

First Posted

October 3, 2017

Study Start

October 13, 2017

Primary Completion

October 13, 2023

Study Completion

October 13, 2023

Last Updated

October 18, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations