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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599830
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Patients With Cancer Who Start Immunotherapy All Neoplasms Other: Cognitive test passations Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Study of the Cognition of Patients Treated With
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : October 2023
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599830


Contacts
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Contact: Florence JOLY, Prof 0231455050 f.joly@baclesse.unicancer.fr

Locations
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France
Chu Amiens Recruiting
Amiens, France
Contact: Mathieu BOONE, MD         
CHU CAEN Recruiting
Caen, France, 14000
Contact: Michel DEPONTVILLE, MD         
Centre François Baclesse Recruiting
Caen, France
Contact: Florence JOLY, Prof         
Chru Lille Recruiting
Lille, France
Contact: Laurent MORTIER, Pr         
Sponsors and Collaborators
Centre Francois Baclesse
More Information
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03599830    
Other Study ID Numbers: 2018-A01041-54
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
Immunotherapy
Cognition
Cancer