Localized, Operable Non-small Cell Lung CancerCOGNIPULMNCT07160751
Cognition and Patients With Lung Cancer
An observational study of Localized, Operable Non-small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Cognitive complaints in patients treated for cancer can impact their quality of life. Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Localized, Operable Non-small Cell Lung Cancer
- What is being tested?
- Self-questionnaire, Cognitive tests and Assessment of the impact of social vulnerability on patient complaints
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2026to Jan 2029
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population includes adults aged 18 to 74 years with suspected localized and operable non-small cell lung cancer. Patients whose cancer diagnosis is not confirmed after inclusion will be prematurely withdrawn from the study
Who may be able to join
- Adult patient aged 18 to 74 years
- Suspected or confirmed localized and operable non-small cell lung cancer (NSCLC)
- Surgical treatment with or without perioperative systemic medical therapy
- Ability to independently complete self-questionnaires via the Cleanweb platform
- Patients with access to a phone, tablet, or computer at home to complete the electronic self-questionnaires.
Who cannot join
- Known pre-existing cognitive disorders
- Presence on the day of inclusion of one or more factors causing mental confusion: electrolyte imbalances, renal failure, hepatic failure, infections, bladder distension, fecal impaction
- Known psychiatric or neurological diseases (e.g., multiple sclerosis, Parkinson's disease, dementia, stroke, traumatic brain injury with loss of consciousness)
- Current use of neuroleptic treatments
- History of cancer treatment within the past 10 years
- Fibromyalgia
- Individuals who cannot read French or are not French-speaking
- Patients who have never attended school
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aline DECHANET, Project manager contact
France1 site, 1 recruiting
- Recruiting
Hôpital Cochin - Service de pneumologie
Paris, Île-de-France Region
Isabelle HARDY LEGER, 01 58 41 24 01 ext. +33, isabelle.leger@aphp.fr
About this study
Official title: Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer
Cognitive complaints in patients treated for cancer can impact their quality of life.
Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway.
Read more
In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time.
The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined.
The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.
Read the detailed description
Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.
These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.
Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.
They significantly impair functional independence and quality of life for cancer patients.
A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.
Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.
These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.
According to one study, 26% of lung cancer survivors present with CRCI.
Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.
Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.
Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.
Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.
Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.
A French-language framework and international guidelines have been developed to help standardize cognitive assessment.
Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.
Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.
Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).
- Being tested
- Self-questionnaire, Cognitive tests, Assessment of the impact of social vulnerability on patient complaints
- Keywords
- localized, Operable non-small cell lung cancer,, Cognitive complaints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaireOther
FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire
Cognitive testsOther
Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.
Assessment of the impact of social vulnerability on patient complaintsOther
EPICES at month 12
| Study group | Role | What they receive |
|---|---|---|
| Surgery only | Not described Receives: Other: Self-questionnaire | |
| Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery | Not described Receives: Other: Cognitive tests | |
| Surgery followed by adjuvant treatment (chemotherapy) | Not described Receives: Other: Assessment of the impact of social vulnerability on patient complaints |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) self-report questionnaire : min =0, max=132
Measured: 12 months
Secondary outcomes (8)
Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min = 0, max=132
Measured: 12 months
Determine whether there is a clinical and/or social phenotype associated with mood
Hospital Anxiety and Depression scale (HADS) : min=0, max=42
Measured: 12 months
Determine whether there is a clinical and/or social phenotype associated with fatigue
European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100
Measured: 12 months
Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min=0, max=132
Measured: 12 months
Assessment of the impact of perioperative surgical and medical treatments on mood.
Hospital Anxiety and Depression scale (HADS ): min=0, max=42
Measured: 12 months
Assessment of the impact of perioperative surgical and medical treatments on fatigue.
European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100
Measured: 12 months
Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition
Cognitive tests recommended by the International Cognition and Cancer Task Force (ICCTF) :
Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.
Measured: 12 months
Assessment of the impact of social vulnerability on patient complaints
Assessment of Precarity and Health Inequalities in Health Examination Centers (EPICES): min = 0, max = 100.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start24 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized, Operable Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Isabelle HARDY LEGER, Principal investigator, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160751
- Sponsor's protocol ID
- APHP250754
- Acronym
- COGNIPULM
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07160751
- Acronym / sponsor ID
- COGNIPULM / APHP250754
- Keywords
- localized, Operable non-small cell lung cancer,, Cognitive complaints
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 8 Sep 2025 (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.
Cognitive complaints in patients treated for cancer can impact their quality of life.
Studies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway.
In a population of patients treated for confirmed localized non-small cell lung cancer (NSCLC), this study aims to detect and monitor the onset of cognitive complaints over time.
The timing of the complaints during the treatment, the cognitive functions affected (memory, attention, concentration…), as well as the perceived intensity of the discomfort, will be examined.
The study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.
Detailed description
Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.
These difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.
Although generally mild to moderate, they can limit patients' ability to return to work and manage daily tasks. These cognitive difficulties are often associated with mood changes and increased fatigue.
They significantly impair functional independence and quality of life for cancer patients.
A baseline assessment of cognitive function prior to treatment is essential. Various factors-such as age, medical or psychiatric history, social vulnerability, or other neurological and psychological risk factors-may preexist the cancer diagnosis.
Subsequently, the impact of the disease itself, the treatments, changes in socio-professional status, and increased or induced socioeconomic hardship, as well as psychological upheaval (such as receiving the diagnosis, anxiety, or family disruptions), may all lead to cognitive disturbances.
These disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.
According to one study, 26% of lung cancer survivors present with CRCI.
Biological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.
Current research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.
Various risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.
Cognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.
Yet too few patients are informed of the existence of CRCI, even though awareness of these issues can directly impact their abilities-particularly in the professional sphere.
A French-language framework and international guidelines have been developed to help standardize cognitive assessment.
Nevertheless, the absence of methodological consensus on the selection of variables (biomarkers, cognitive tests, adjustment factors), measurements, analysis of results, and timing of evaluations leads to these difficulties being underdiagnosed.
Thus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.
Based on the recommendations of the Association Francophone des Soins Oncologiques de Support (AFSOS), which emphasize the importance of raising clinicians' awareness of the "chemofog/CRCI" issue-both to better define cognitive complaints and to propose appropriate management-our study aims to examine cognitive complaints in individuals diagnosed with confirmed, operable, localized non-small cell lung cancer (NSCLC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgery only | – | Other: Self-questionnaire |
| Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery | – | Other: Cognitive tests |
| Surgery followed by adjuvant treatment (chemotherapy) | – | Other: Assessment of the impact of social vulnerability on patient complaints |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes adults aged 18 to 74 years with suspected localized and operable non-small cell lung cancer. Patients whose cancer diagnosis is not confirmed after inclusion will be prematurely withdrawn from the study
Key inclusion criteria (5 listed)
- Adult patient aged 18 to 74 years
- Suspected or confirmed localized and operable non-small cell lung cancer (NSCLC)
- Surgical treatment with or without perioperative systemic medical therapy
- Ability to independently complete self-questionnaires via the Cleanweb platform
- Patients with access to a phone, tablet, or computer at home to complete the electronic self-questionnaires.
Key exclusion criteria (8 listed)
- Known pre-existing cognitive disorders
- Presence on the day of inclusion of one or more factors causing mental confusion: electrolyte imbalances, renal failure, hepatic failure, infections, bladder distension, fecal impaction
- Known psychiatric or neurological diseases (e.g., multiple sclerosis, Parkinson's disease, dementia, stroke, traumatic brain injury with loss of consciousness)
- Current use of neuroleptic treatments
- History of cancer treatment within the past 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaireFACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire | Other | Surgery only |
| Cognitive testsHopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV. | Other | Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery |
| Assessment of the impact of social vulnerability on patient complaintsEPICES at month 12 | Other | Surgery followed by adjuvant treatment (chemotherapy) |
Primary outcome
To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score
Time frame: 12 months
Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) self-report questionnaire : min =0, max=132
8 secondary outcomes
Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.
Time frame: 12 months
Determine whether there is a clinical and/or social phenotype associated with mood
Time frame: 12 months
Determine whether there is a clinical and/or social phenotype associated with fatigue
Time frame: 12 months
Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint
Time frame: 12 months
Assessment of the impact of perioperative surgical and medical treatments on mood.
Time frame: 12 months
Assessment of the impact of perioperative surgical and medical treatments on fatigue.
Time frame: 12 months
Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition
Time frame: 12 months
Assessment of the impact of social vulnerability on patient complaints
Time frame: 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 22 Oct 2026.
- Individual participant dataSharing planned: No
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.
Aline DECHANET, Project manager contact
Isabelle HARDY LEGER principal investigator
Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie.
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 Localized, Operable Non-small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 8 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 22 Oct 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 France. 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 Isabelle HARDY LEGER (01 58 41 24 01 ext. +33, isabelle.leger@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score (time frame: 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 22 Oct 2026.