Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients

Study Purpose

Cancer is a frequent disease considering that one person out of three will be confronted with it in their lifetime. Cancer patients often express complaints related to cognitive impairment as an outcome of their oncological treatment. These cognitive disorders have a significant impact on the patient's and their carer's quality of life. Therefore, it appears necessary to have a reliable, quick and simple tool in order to detect cognitive impairment. The rationale of this study relies on 3 main points :

- The cognitive complaint frequently reported by cancer patients.

- The difficulty in reliably demonstrating the cause of this complaint through conventional neuropsychological tests.

- The interest of cognitive processing speed as an indicator of cognitive dysfunction.

The primary objective of the study is to evaluate a potential variation of cognitive processing speed at the Saint-Louis Lille Battery (SSLIB) between the beginning and during (4 months after the beginning) the oncological treatment of adults with breast cancer or colon cancer.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	20 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Beginning an oncological treatment for breast or colon cancer.

- Patients of age ≥ 20 and ≤ 70 years old.

- Cancer diagnosis announcement delivered since less than 3 weeks (+/- a week) - Patient affiliated to French social security.

Exclusion Criteria:

- Patient's opposition to the study.

- Notion of an abnormal cerebral scan or MRI.

- Drug use (alcohol, narcotics.

..)

- Chronic (≥ 15 days) treatment with corticosteroids > 1mg/kg/j (prednisone or equivalent) - Ocular pathology or cognitive disorder impairing comprehension and reading abilities.

- Patients under curatorship, guardianship or under the protection of justice

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05754060
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Colon Cancer, Cognitive Impairment

Arms & Interventions

Arms

: Saint-Louis Lille Battery (SSLIB)

Saint-Louis Lille Battery (SSLIB) is composed of three tests studying the speed of cognitive processing and proposed to the subjects on a tactile tablet. These three tasks are: (a) Reaction time tasks specifically developed for this study b) A digital adaptation of the WAIS-IV code subtest c) A digital version of the Trail Making Test (A and B)

Interventions

Other: - Saint-Louis Lille Battery (SSLIB)

Saint-Louis Lille Battery (SSLIB) composed of three tests studying the speed of cognitive processing and proposed to the subjects on a tactile tablet. These three tasks are: (a) Reaction time tasks specifically developed for this study b) A digital adaptation of the WAIS-IV code subtest c) A digital version of the Trail Making Test (A and B)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Catherine Belin, Dr

[email protected]

+33171207466

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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