Cancer Related Cognitive ImpairmentNCT07582770
Cognitive Impairment Assessment in Breast Cancer Survivors
An observational study of Cancer Related Cognitive Impairment and Breast Cancer Survivors, run by European Institute of Oncology at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Related Cognitive Impairment, Breast Cancer Survivors
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- May 2026to Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, 20435
Gabriella Pravettoni, MD, PhD, +39 0257489731, gabriella.pravettoni@ieo.it
Gabriella Pravettoni, MD, PhD
About this study
Official title: Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Female breast cancer survivors | |
| Non-cancer control | Female without any history of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startMay 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Related Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582770
- Sponsor's protocol ID
- UIS 5283
- Other IDs
- L2-589
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT07582770
- Acronym / sponsor ID
- UIS 5283
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | – | –Female breast cancer survivors |
| Non-cancer control | – | –Female without any history of cancer |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Related Cognitive Impairment and Breast Cancer Survivors, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni, MD, PhD (+39 0257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.