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NOT YET RECRUITING
NCT06116929
NA

Hodgkin's Disease and Chemotherapy Before 40 Years

Sponsor: Lille Catholic University

View on ClinicalTrials.gov

Summary

A few studies have focused on other solid cancers (colorectal, prostate). On the other hand, the study of cognitive impairment in Hodgkin's disease remains less developed, and structural and functional post-therapy MRI studies have never been carried out. The impact of cognitive impairment on Hodgkin's disease is rarely, if ever, assessed in routine clinical practice, despite the fact that it is truly disabling in 16 to 30% of patients. Cognitive impairment can persist long after diagnosis and treatment. A recent study examining cognitive functioning in patients an average of 13 years after treatment found that disorders persisted in 52% of cases, with attentional, working memory and dysexecutive (planning) difficulties. These disorders have a significant impact on the daily and professional lives of these young, often working patients. Their rapid development and persistence after treatment can therefore represent a real limiting factor, impacting both professional integration and quality of life. Finally, the current state of knowledge does not allow us to dissociate cognitive disorders from emotional disorders and fatigue, which represent a major patient complaint. A better definition of the nature, pathophysiology and specificity of these disorders would therefore enable us to take better account of their repercussions (social, professional and on quality of life) and provide better care (in terms of cognitive remediation or psychological support). A prospective, longitudinal, multicenter, case-control interventional study in which cases are patients with Hodgkin's disease (HD) treated with CT +/- radiotherapy and controls are healthy participants will be conducted. The aim is to study the prevalence and nature of treatment-induced cognitive impairment and its correlation with emotional comorbidities, as well as structural and functional brain disorders on MRI. The patient will thus be his or her own witness, the reference state being that at the time of diagnosis, before any treatment. The fact that this state has not already been altered by the disease itself, will be verify thanks to comparison with controls.

Official title: Functional and Cognitive Assessment of Patients With Hodgkin's Disease Undergoing Chemotherapy Before 40 Years

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2024-05-15

Completion Date

2028-01-01

Last Updated

2024-02-28

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Morphological and functional magnetic resonance imaging (MRI)

Patients will undergo 3 morphological and functional MRI scans (during rest and activity) on the 3T MRI scanner at St Philibert Hospital (Lille, France) at 0 (M0), 6 (M6) and 12 (M12) months. The controls will perform a single functional MRI on the 3T MRI.

OTHER

Neuropsychological assessment

3 neuropsychological assessments will be carried out at M0, M6 and M12, by the same neuropsychologist for all patients included. Controls will undergo the same neuropsychological assessments, but only once.

Locations (4)

Centre Hospitalier Artois Ternois

Arras, France

Hôpital Claude Huriez

Lille, France

Hôpital Saint-Philibert

Lomme, France

Hôpital Victor Provo

Roubaix, France