Cognitive Impairment Assessment in Breast Cancer Survivors | NCT07582770

Studies
Cognitive Impairment Assessment in Breast Cancer Survivors

NCT07582770

Sponsor

European Institute of Oncology

Status

Not yet recruiting

Last Update Posted

May 13, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Cancer Related Cognitive Impairment
Breast Cancer Survivors

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
L2-589	Other Identifier	Comitato Etico Territoriale Lombardia 2

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

Apr 2030Estimated

Completion Date

Apr 2030Estimated

First Submitted Date

May 6, 2026

First Submission Date that Met QC Criteria

May 6, 2026

First Posted Date

May 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Breast cancer survivors		Female breast cancer survivors
Non-cancer control		Female without any history of cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validation of a second-level cognitive test battery to be employed for clinical use for the detection of CRCI in breast cancer survivors	Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests.	At enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Female breast cancer survivors (N = 100) will be recruited at the European Institute of Oncology (IEO) while, female non-cancer controls (N = 100) will be recruited though an invitation to participate in the study, accompanied by a brief description of its objectives and procedures, that will be disseminated via social media groups, word of mouth and breast cancer patient associations.

Sampling Method

Non-Probability Sample