Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT07160751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognition and Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To examine the onset, intensity and duration of the PCI (Perceived Cognitive Impairment) score', 'timeFrame': '12 months', 'description': 'Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) self-report questionnaire : min =0, max=132'}], 'secondaryOutcomes': [{'measure': 'Determine whether there is a clinical and/or social phenotype associated with cognitive complaint.', 'timeFrame': '12 months', 'description': 'Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min = 0, max=132'}, {'measure': 'Determine whether there is a clinical and/or social phenotype associated with mood', 'timeFrame': '12 months', 'description': 'Hospital Anxiety and Depression scale (HADS) : min=0, max=42'}, {'measure': 'Determine whether there is a clinical and/or social phenotype associated with fatigue', 'timeFrame': '12 months', 'description': 'European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100'}, {'measure': 'Assessment of the impact of perioperative surgical and medical treatments on cognitive complaint', 'timeFrame': '12 months', 'description': 'Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) : min=0, max=132'}, {'measure': 'Assessment of the impact of perioperative surgical and medical treatments on mood.', 'timeFrame': '12 months', 'description': 'Hospital Anxiety and Depression scale (HADS ): min=0, max=42'}, {'measure': 'Assessment of the impact of perioperative surgical and medical treatments on fatigue.', 'timeFrame': '12 months', 'description': 'European Organisation for Research and Treatment of Cancer - Fatigue Scale (EORTC QLQ-FA12) : min=0, max=100'}, {'measure': "Objective assessment via cognitive tests of the impact of cancer, treatments and co-factors on patients' cognition", 'timeFrame': '12 months', 'description': 'Cognitive tests recommended by the International Cognition and Cancer Task Force (ICCTF) :\n\nHopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.'}, {'measure': 'Assessment of the impact of social vulnerability on patient complaints', 'timeFrame': '12 months', 'description': 'Assessment of Precarity and Health Inequalities in Health Examination Centers (EPICES): min = 0, max = 100.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['localized', 'Operable non-small cell lung cancer,', 'Cognitive complaints'], 'conditions': ['Localized, Operable Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Cognitive complaints in patients treated for cancer can impact their quality of life.\n\nStudies show that these cognitive complaints may have multifactorial origins and appear at different stages of the care pathway.\n\nIn 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.\n\nThe 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.\n\nThe study also explores the influence of co-factors such as mood, fatigue, socio-cultural status, and level of social vulnerability on these cognitive complaints.', 'detailedDescription': 'Chemofog" is the term used to describe cognitive difficulties associated with cancer treatments, such as chemotherapy, radiotherapy, and surgery.\n\nThese difficulties may include problems with memory, executive functions, attention, orientation, verbal comprehension, and information processing speed, and can occur during and after treatment.\n\nAlthough 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.\n\nThey significantly impair functional independence and quality of life for cancer patients.\n\nA 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.\n\nSubsequently, 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.\n\nThese disturbances, referred to as Cancer-Related Cognitive Impairment (CRCI), affect the quality of life of cancer survivors.\n\nAccording to one study, 26% of lung cancer survivors present with CRCI.\n\nBiological and genetic factors such as cellular senescence, inflammatory processes, and DNA damage are thought to play a role in the development of CRCI.\n\nCurrent research seeks to identify relevant biomarkers of cognitive decline, such as cytokine levels, to better understand its mechanisms and improve its management.\n\nVarious risk factors for CRCI have been identified: advanced age, lower baseline cognitive functioning, and lack of physical activity.\n\nCognitive complaints have been recognized for more than 20 years and may affect up to 75% of cancer patients, regardless of cancer type.\n\nYet 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.\n\nA French-language framework and international guidelines have been developed to help standardize cognitive assessment.\n\nNevertheless, 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.\n\nThus, further studies are needed to investigate this subject and ultimately implement appropriate management strategies.\n\nBased 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patient aged 18 to 74 years\n* Suspected or confirmed localized and operable non-small cell lung cancer (NSCLC)\n* Surgical treatment with or without perioperative systemic medical therapy\n* Ability to independently complete self-questionnaires via the Cleanweb platform\n* Patients with access to a phone, tablet, or computer at home to complete the electronic self-questionnaires.\n\nExclusion Criteria:\n\n* Known pre-existing cognitive disorders\n* 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\n* Known psychiatric or neurological diseases (e.g., multiple sclerosis, Parkinson's disease, dementia, stroke, traumatic brain injury with loss of consciousness)\n* Current use of neuroleptic treatments\n* History of cancer treatment within the past 10 years\n* Fibromyalgia\n* Individuals who cannot read French or are not French-speaking\n* Patients who have never attended school"}, 'identificationModule': {'nctId': 'NCT07160751', 'acronym': 'COGNIPULM', 'briefTitle': 'Cognition and Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Observation of Cognitive Complaints in Patients With Localized, Operable Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'APHP250754'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery only', 'interventionNames': ['Other: Self-questionnaire']}, {'label': 'Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery', 'interventionNames': ['Other: Cognitive tests']}, {'label': 'Surgery followed by adjuvant treatment (chemotherapy)', 'interventionNames': ['Other: Assessment of the impact of social vulnerability on patient complaints']}], 'interventions': [{'name': 'Self-questionnaire', 'type': 'OTHER', 'description': 'FACT-Cog, HADS, FA12, EPICES, socio-professional and socio-demographic questionnaire', 'armGroupLabels': ['Surgery only']}, {'name': 'Cognitive tests', 'type': 'OTHER', 'description': 'Hopkins Verbal Learning Test (HVLT). Trail Making Test (TMT). Verbal fluency test. Digit memory WAIS-IV.', 'armGroupLabels': ['Neoadjuvant treatment (chemotherapy or chemoimmunotherapy) followed by surgery']}, {'name': 'Assessment of the impact of social vulnerability on patient complaints', 'type': 'OTHER', 'description': 'EPICES at month 12', 'armGroupLabels': ['Surgery followed by adjuvant treatment (chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'contacts': [{'name': 'Isabelle HARDY LEGER', 'role': 'CONTACT', 'email': 'isabelle.leger@aphp.fr', 'phone': '01 58 41 24 01', 'phoneExt': '+33'}], 'facility': 'Hôpital Cochin - Service de pneumologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Isabelle HARDY LEGER', 'role': 'CONTACT', 'email': 'isabelle.leger@aphp.fr', 'phone': '01 58 41 24 01', 'phoneExt': '+33'}, {'name': 'Aline DECHANET, Project manager', 'role': 'CONTACT', 'email': 'aline.dechanet@aphp.fr'}], 'overallOfficials': [{'name': 'Isabelle HARDY LEGER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de pneumologie.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}