NeoplasmsMOCA-2NCT03299855
MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
A study testing Passation of neuropsychological test in people with Neoplasms, run by Centre Francois Baclesse at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Passation of neuropsychological test
- How many people
- 104 participants
- Where
- 6 sitesFrance
- Study dates
- 13 Oct 2017to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre François Baclesse
Caen
CHU
Caen
CH
Cherbourg
Ch Compiegne
Compiègne
Centre Henri Becquerel
Rouen
Centre Hospitalier
Saint-Lô
About this study
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.
- Conditions
- Neoplasms
- Being tested
- Passation of neuropsychological test
- Keywords
- oncogeriatric, MMS, MoCA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passation of neuropsychological testOther
Passation of MoCA and MMS tests associated with neuropsychological test
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity of MoCA test
MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%
Measured: Up 2 months after inclusion, before initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start13 Oct 2017
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Passation of MMS and MoCA tests associated to passation of neuropsychological test
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- UCOG (Unite de coordination en Onco-Gériatrie)
- Responsible party
- Sponsor
- Investigators
- florence JOLY, prof, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299855
- Sponsor's protocol ID
- 2017-A01079-44
- Acronym
- MOCA-2
- Status last verified
- Sep 2023
- First submitted
- 26 Sep 2017
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MoCA vs. MMS: Which Tool to Detect Cognitive Disorders in Oncogeriatric?
- ClinicalTrials.gov ID
- NCT03299855
- Acronym / sponsor ID
- MOCA-2 / 2017-A01079-44
- Conditions
- Neoplasms
- Keywords
- oncogeriatric, MMS, MoCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- UCOG (Unite de coordination en Onco-Gériatrie)
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Model description
- Passation of MMS and MoCA tests associated to passation of neuropsychological test
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passation of neuropsychological testPassation of MoCA and MMS tests associated with neuropsychological test | Other | – |
Primary outcome
Evaluate the sensitivity of MoCA test
Time frame: Up 2 months after inclusion, before initiation of treatment
MoCA is considered clinically relevant if its sensitivity to identify patients with cognitive impairment is at least 75%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
florence JOLY, prof principal investigator
Centre François Baclesse
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passation of neuropsychological test in people with Neoplasms, run by Centre Francois Baclesse at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the sensitivity of MoCA test (time frame: Up 2 months after inclusion, before initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.