Study of the Cognition of Patients Treated With Immunotherapy (COG-IMMUNO)

February 8, 2024 updated by: Centre Francois Baclesse

Study of the Cognition of Patients Treated With

The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology.

Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer.

The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Chu Amiens
      • Caen, France
        • Centre Francois Baclesse
      • Caen, France, 14000
        • CHU Caen
      • Lille, France
        • Chru Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient over the age of 18,
  • Patient with cancer and having to initiate treatment with immunotherapy alone
  • Treatment with immunotherapy will include either an anti-PD1 / L1 or Anti CTLA4 monotherapy or combination,
  • Patients may have received other antitumor treatments other than immunotherapy but these should be stopped at the time of initiation of immunotherapy
  • Performance Status <2
  • Patient at the level of studies 3 "end of primary studies" minimum (Barbizet scale),
  • Mastery of the French language.
  • Patient affiliated to a social security system
  • Patient having attested in writing of his non-opposition to participate in the study

Exclusion Criteria:

  • Previous treatment with immunotherapy
  • Another anti-tumor treatment underway
  • Primary cancer of the central nervous system or cerebral metastasis, symptomatics and not controlled
  • Abuse of alcohol or drug use
  • Severe visual and / or auditory deficiency,
  • Refusal of participation of the patient.
  • Patient deprived of liberty or under guardianship
  • Patient unable to follow the study for geographical, social or psychopathological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cognitive test passations
3 neuropsychological passations over a period of 6 months.
Other: Cognitive test passations

Tests :

MoCA2 Hopkins verbal learning test WAIS-IV Trail Making test Stroop Verbal fluences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognitive function (at least in a cognitive domain)
Time Frame: between inclusion and 3 months.
The proportion of patients who will have a reduction of scores in neuropsychological questionnaires (scores of MoCA2, Hopkins verbal learning test, WAIS-IV, Trail Making test, Stroop Symboles)
between inclusion and 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2018

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-A01041-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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