MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in... | NCT03299855

Studies
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?

NCT03299855

Sponsor

Centre Francois Baclesse

Status

Completed

Last Update Posted

Oct 18, 2023Actual

Enrollment

104Actual

Phase

Not Applicable

Conditions

Neoplasms

Interventions

Passation of neuropsychological test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 13, 2017Actual

Primary Completion Date

Oct 13, 2023Actual

Completion Date

Oct 13, 2023Actual

First Submitted Date

Sep 26, 2017

First Submission Date that Met QC Criteria

Oct 2, 2017

First Posted Date

Oct 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2023

Last Update Posted Date

Oct 18, 2023Actual

Name	Class
UCOG (Unite de coordination en Onco-Gériatrie)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Passation of neuropsychological test	Other	Passation of MoCA and MMS tests associated with neuropsychological test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
florence JOLY, prof	Centre François Baclesse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre François Baclesse		Caen			France
CHU

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided