Clinical trial · Observational
Cognitive Impairment Assessment in Breast Cancer Survivors
Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors
NCT07582770CI-TRIAL-00111396not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Survivors | — | UNRESOLVED | — |
| Cancer Related Cognitive Impairment | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Breast cancer survivors
- description
- Female breast cancer survivors
- label
- Non-cancer control
- description
- Female without any history of cancer
Primary outcomes (1)
- measure
- Validation of a second-level cognitive test battery to be employed for clinical use for the detection of CRCI in breast cancer survivors
- timeFrame
- At enrollment
- description
- Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.