Lung DiseaseNCT06727370
Cognitive Screening in Lung Cancer Patients
An observational study of Lung Disease and NSCLC (Non-small Cell Lung Cancer), run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Disease, NSCLC (Non-small Cell Lung Cancer), SCLC
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2024to 31 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with lung cancer (both SCLC and NSCLC)
Who may be able to join
- Small-cell and non-small-cell lung cancer (stage I, II, III, IV)
- Age ≥ 18 years
- Patients able to speak and read the local language(s) fluently
- Acceptance and signature of informed consent
Who cannot join
- Age ≥ 70
- Presence of brain metastases
- Patients with concomitant neurological or psychiatric disorders.
- Patients undergoing brain radiotherapy
- Previous diagnosis of lung cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lorenzo Conti contact
Italy1 site, 1 recruiting
- Recruiting
Istituto Europeo di Oncologia
Milan, 20141
Gabriella Pravettoni, +390257489731, gabriella.pravettoni@ieo.it
About this study
This study aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.
- Conditions
- Lung Disease, NSCLC (Non-small Cell Lung Cancer), SCLC
- Keywords
- lung cancer, nsclc, sclc, cognitive
- Medical subject headings
- Lung Diseases, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Small Cell Lung Carcinoma
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 |
|---|---|---|
| patients diagnosed with lung cancer | patients diagnosed with lung cancer (both SCLC and NSCLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive impairment
It will be the presence of cognitive impairment through the administration of a comprehensive neuropsychological assessment.Patient will complete cognitive evaluation which includes:the Montreal Cognitive Assessment and the Mini-Mental State Examination to assess global cognitive functioning;the Frontal Assessment Battery,the Stroop test color and word test ,and the Verbal Fluency Test for the evaluation of executive function;the Ray Auditory Verbal Learning Test for learning and memory;the forward and backward Digit Span and the Corsi Block-tapping Test for working memory;and the Trail Making Test A \& B and the Symbol Digit Modalities Test for attention. Classification will be obtained adopting the criteria proposed by the International Cognition and Cancer Task Force,a test score of 2 SDs or more below the test-specific reference cohort on at least 1 test of a cognitive domain.All test scores were transformed into z-scores to allow the comparison between different measures.
Measured: From baseline to 12 months
Secondary outcomes (1)
Risk factors on the cognitive profile of lung cancer patients
This study will assess the influence of different risk factors on the cognitive profile of lung cancer patients. It will examine the role of psychological symptoms through different self-reported questionnaire: the Functional Assessment of Cancer Therapy - cognition will be administered to assess perceived cognitive impairment, the Beck Depression Inventory II to measure the presence of depressive symptoms, the State-Trait Anxiety Inventory to investigate both state anxiety and trait anxiety, the EORTC-Quality of Life of cancer patient to assess the quality of life and, finally, the Pittsburgh Sleep Quality Index to evaluate sleep quality and disturbances sleep patterns. Finally, the Cognitive Reserve Index questionnaire will be administered to obtain the cognitive reserve level of each patient, and the smoking information obtained through an interview.All the questionnaire scores were transformed into z-scores to allow the comparison between different measures.
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start10 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, Principal investigator, Istituto Europeo di Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727370
- Sponsor's protocol ID
- IEO 2027
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 10 Dec 2024
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Screening in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT06727370
- Acronym / sponsor ID
- IEO 2027
- Conditions
- Lung Disease, NSCLC (Non-small Cell Lung Cancer), SCLC
- Keywords
- lung cancer, nsclc, sclc, cognitive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Dec 2024 (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 aims to investigate the occurrence of cancer and adjuvant therapy-related cognitive impairment in patients with both NSCLC and SCLC. The primary endpoint measure will be the presence of cognitive impairment during the first year after enrollment through the administration of a comprehensive neuropsychological assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with lung cancer | – | –patients diagnosed with lung cancer (both SCLC and NSCLC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with lung cancer (both SCLC and NSCLC)
Key inclusion criteria (4 listed)
- Small-cell and non-small-cell lung cancer (stage I, II, III, IV)
- Age ≥ 18 years
- Patients able to speak and read the local language(s) fluently
- Acceptance and signature of informed consent
Key exclusion criteria (5 listed)
- Age ≥ 70
- Presence of brain metastases
- Patients with concomitant neurological or psychiatric disorders.
- Patients undergoing brain radiotherapy
- Previous diagnosis of lung cancer
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
cognitive impairment
Time frame: From baseline to 12 months
It will be the presence of cognitive impairment through the administration of a comprehensive neuropsychological assessment.Patient will complete cognitive evaluation which includes:the Montreal Cognitive Assessment and the Mini-Mental State Examination to assess global cognitive functioning;the Frontal Assessment Battery,the Stroop test color and word test ,and the Verbal Fluency Test for the evaluation of executive function;the Ray Auditory Verbal Learning Test for learning and memory;the forward and backward Digit Span and the Corsi Block-tapping Test for working memory;and the Trail Making Test A \& B and the Symbol Digit Modalities Test for attention. Classification will be obtained adopting the criteria proposed by the International Cognition and Cancer Task Force,a test score of 2 SDs or more below the test-specific reference cohort on at least 1 test of a cognitive domain.All test scores were transformed into z-scores to allow the comparison between different measures.
1 secondary outcome
Risk factors on the cognitive profile of lung cancer patients
Time frame: From baseline to 12 months
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 10 Dec 2024.
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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.
Lorenzo Conti contact
Gabriella Pravettoni principal investigator
Istituto Europeo di Oncologia
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 Lung Disease and NSCLC (Non-small Cell Lung Cancer), 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 5 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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 (+39025489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive impairment (time frame: From baseline to 12 months). 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 10 Dec 2024.