Cognitive Impairment Assessment in Breast Cancer Survivors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorEuropean Institute of Oncology
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Breast cancer survivors
Group B: Non-cancer control
Trial outcomes
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
Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests.
Time frame
At enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: