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NCT Number: NCT07582770

Cognitive Impairment Assessment in Breast Cancer Survivors

This study is a monocentric, observational, cross-sectional study with a case-control design, aimed at evaluating the construct validity, discriminative ability, and diagnostic accuracy of a second-level neuropsychological test battery for the detection of cancer-related cognitive impairment in breast cancer survivors.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

European Institute of Oncology

Milan, 20435, Italy

Location contact

Gabriella Pravettoni, MD, PhD

CONTACT

[email protected]

+39 0257489731

Gabriella Pravettoni, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Participants will undergo a comprehensive neuropsychological assessment including both paper-and-pencil tests to be validated and their corresponding comparator instruments, in order to evaluate sensitivity, specificity, and convergent validity across multiple cognitive domains.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years old
  • Patient with a previous documented diagnosis of non-metastatic breast cancer (only for breast cancer survivor gruop)
  • Patient has completed chemotherapy for at least 6 months and for a maximum of 36 months if planned (only for breast cancer survivor gruop)
  • Understanding of the Italian language and ability to give informed consent

Exclusion criteria

  • Presence of brain metastases or history of brain radiation therapy (only for breast cancer survivor gruop)
  • Patient with previous diagnosis of other malignant tumors in addition to breast cancer (only for breast cancer survivor gruop)
  • Patient with a previous diagnosis of malignant carcinomas (only for control gruop)
  • Patient with a history of brain damage with unresolved neurological consequences
  • Patient with previous or current serious neurological pathologies
  • Patient with severe psychiatric conditions
  • Patient with systemic pathologies that could interfere with cognitive abilities
  • Patient taking medications that have a strong cognitive impact and that have not been stabilized for at least 4 weeks prior to enrollment
  • Patient with visual or hearing impairments that are not properly corrected
  • Patient with any disability that might compromise the validity of cognitive tests

Treatment and study plan

Primary outcomes

  1. Validation of a second-level cognitive test battery to be employed for clinical use for the detection of CRCI in breast cancer survivors

    Time frame: At enrollment

    Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Pravettoni, MD, PhD

CONTACT

[email protected]

+39 0257489731

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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