MedTrace Logo

Hodgkin's Disease and Chemotherapy Before 40 Years

NCT06116929 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Hodgkin Disease

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.

Sponsors & Collaborators

  • Lille Catholic University

    lead OTHER

Principal Investigators

  • Sandy AMORIM · Onco-Hematology Department-Hôpital Saint Vincent de Paul-GHICL

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2027-07-01
Completion
2028-01-01

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116929 on ClinicalTrials.gov