Evidence map›Paper›PMID 36513991›Full record

ArticleBMC cancer2022

Cognitive assessment in patients treated by immunotherapy: the prospective Cog-Immuno trial.

Marie Lange, Bénédicte Clarisse, Alexandra Leconte, Kléouforo-Paul Dembélé, Justine Lequesne, Celeste Nicola, Martine Dubois, Laurence Derues, Yori Gidron, Hélène Castel and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03599830 (Study of the Cognition of Patients Treated With), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03599830 nacompletednot on this map

Study of the Cognition of Patients Treated With

TypeinterventionalSponsorCentre Francois BaclesseRan2018 to 2023Enrolled90ConditionsPatients With Cancer Who Start Immunotherapy, All NeoplasmsArmsCognitive test passations
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Immune checkpoint inhibition perturbs neuro-immune homeostasis and impairs cognitive function.Journal of experimental & clinical cancer research : CR · 2025
    Article
  7. Review
  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 3 countries.

Marie LangeClinical Research Department, Centre François Baclesse, 14000, Caen, France. m.lange@baclesse.unicancer.fr.ORCID http://orcid.org/0000-0002-1749-2713
Bénédicte ClarisseClinical Research Department, Centre François Baclesse, 14000, Caen, France.
Alexandra LeconteClinical Research Department, Centre François Baclesse, 14000, Caen, France.
Kléouforo-Paul DembéléCancer & Cognition Platform, Ligue Contre le Cancer, 14000, Caen, France.
Justine LequesneClinical Research Department, Centre François Baclesse, 14000, Caen, France.
Celeste NicolaCancer & Cognition Platform, Ligue Contre le Cancer, 14000, Caen, France.
Martine DuboisCancer & Cognition Platform, Ligue Contre le Cancer, 14000, Caen, France.
Laurence DeruesCancer & Cognition Platform, Ligue Contre le Cancer, 14000, Caen, France.
Yori GidronDept. of Nursing, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.
Hélène CastelCancer & Cognition Platform, Ligue Contre le Cancer, 14000, Caen, France.
Florence JolyClinical Research Department, Centre François Baclesse, 14000, Caen, France.
Inserm · FRCentre François Baclesse · FRUniversity of Haifa · IL

Funding

Bristol-Myers Squibb Foundation (FR) 1709-04-013Canceropôle Nord-Ouest (FR) 2018/15Fondation de France (FR) 00089248
6 · The paper itself

Abstract

backgroundThe discovery of the importance of the immune system and its role in oncogenesis led to the development of immunotherapy, a treatment that represents a major advance in oncology management. Due to the recent nature of immunotherapy, little is known about its side effects and their impact on quality of life. To date, there is no published study that accurately assesses the impact of immunotherapy on cognition, mood and/or fatigue in patients treated for cancer, despite potential neurological toxicities. The purpose of this study is to prospectively assess the incidence of cognitive impairment and cognitive complaints among cancer patients naïve for immunotherapy without concomitant anti-cancer treatment.

methodsThe Cog-Immuno trial is a multicentre longitudinal study addressing patients with cancer candidate to receive immunotherapy alone (n = 100). Immunotherapy treatment will include either anti-PD1/PDL1 or anti-CTLA4 monotherapy or combination therapy. Cognitive and quality of life assessment, electrocardiogram (ECG) and biological tests will be performed at baseline, thereafter 3, and 6 months after immunotherapy initiation. The primary endpoint is the proportion of patients treated by immunotherapy who will experience a decline in cognitive performances or in Montreal Cognitive Assessment (MoCA) score within 3 months after inclusion. Secondary endpoints concern: anxiety, depression, fatigue, clinical characteristics, biological data and neurophysiological measures (heart rate variability and hemispheric lateralization). A pre-clinical study will be conducted in cancer bearing mice receiving checkpoint inhibitors (ICI) with the evaluation of cognitive functions and emotional reactivity, collection of blood samples and investigation of neurobiological mechanisms from brain slices. DISCUSSION: Assessing and understanding the incidence and the severity of cognitive impairment and its impact on quality of life in cancer patients treated by immunotherapy is a major issue. The results of this study will provide information on the impact of these treatments on cognitive functions in order to help the physicians in the choice of the treatment.

trial registrationNCT03599830, registered July 26, 2018. PROTOCOL VERSION: Version 5.1 dated from 2020/10/02.

Indexed as

NeoplasmsQuality of LifeAnimalsCognitionFatigueImmunotherapyLongitudinal StudiesMiceProspective StudiesBlood biomarkersCancerCognitionImmunotherapyPreclinical model

Identifiers

PMID36513991
PMCPMC9749352
OpenAlexW4311277374

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.