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NCT04565769Active, not recruiting

Cognitive Function in Melanoma Patients Treated With Adjuvant Immune Checkpoint Inhibitors

Cognitive Function in Patients Treated for Melanoma With Adjuvant Immune Checkpoint Inhibitors: A Controlled Prospective Observational Study

Source: ClinicalTrials.gov · Last updated 6 Dec 2024

Brief summary (registry, in English)

Immune checkpoint inhibitors (ICIs) are a group of novel immunotherapies that boost the body's own defense against the cancer by improving the immune system's ability to recognize and destroy cancer cells. While it is relatively well-documented that conventional cancer treatments (e.g., chemotherapy) are associated with cognitive impairment, virtually nothing is yet known about effects on cognition during and after ICI treatment. Due to significantly improved survival rates after ICI treatments, it becomes important to map possible adverse effects associated with these treatments. The investigators therefore investigate possible changes in cognitive function in a group of cancer patients from prior to ICI treatment to nine months later. A gender- and age- matched healthy control group will serve as a comparison. The study has the potential to broaden our understanding of associations between cognition, the brain, and the immune system and to provide clinically relevant knowledge about possible cognitive impairments associated with immunotherapy.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
100 (actual)
First submitted
16 Sept 2020
Start date
12 Nov 2020
Primary completion date
31 Mar 2025
Lead sponsor
Aarhus University Hospital
Diseases
Melanoma
NCT number
NCT04565769

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 12 Nov 2020 to the primary completion date, 31 Mar 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous treatment with immunotherapy

Other illness

  • Neurodegenerative diseases (dementia etc.)
  • Known progressive psychiatric diseases (e.g., Schizophrenia)
  • Other confirmed diagnoses with underlying cognitive impairment

Other

  • Substance abuse
  • Insufficient Danish proficiency

Who the study is looking for

  • Confirmed diagnosis of melanoma and scheduled for ICI treatment at Aarhus University Hospital (AUH), Denmark. The healthy control group will consist of an age- and gender- matched sample of participants.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Aarhus University Hospital
Coordinator of this site? Confirm its status
AarhusDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.