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NCT06116929Not yet recruiting

Hodgkin's Disease and Chemotherapy Before 40 Years

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

Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
63 (estimated)
First submitted
31 Oct 2023
Start date
15 May 2024
Primary completion date
1 Jul 2027
Lead sponsor
Lille Catholic University
NCT number
NCT06116929

What you commit to

  • Study type: Interventional
  • Planned participants: 63
  • From 15 May 2024 to the primary completion date, 1 Jul 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Patient with newly diagnosed Hodgkin's disease
  • With intention to treat with chemotherapy +/- radiotherapy
  • Aged between 18 and 40 years
  • Fluency in French
  • Able to undergo neuropsychological evaluation (absence of major sensory disorders)
  • Agreeing to take part in the study and having signed the informed consent form
  • Affiliated with a social security scheme
  • Individual without Hodgkin's disease
  • Aged between 18 and 40
  • Proficient in French
  • Agreeing to participate in the study and having signed the informed consent form
  • Affiliated with a social security scheme
    • Cases and controls will be matched on age (± 5 years difference), and number of years of education (difference ≤ 2 years).
    • Non-inclusion criteria - cases + controls :
  • Claustrophobia preventing MRI from being performed
  • Contraindication to MRI
  • Previous chemotherapy
  • History of neurological or psychiatric illness, including severe depression, or cognitive impairment
  • Use of medications that may cause neurological or psychiatric signs
  • Alcohol or drug abuse
  • Pregnant women
  • Persons under guardianship or trusteeship

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Artois Ternois
Coordinator of this site? Confirm its status
ArrasFranceUnknown status
Hopital Claude Huriez
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Hopital Saint Philibert
Coordinator of this site? Confirm its status
LommeFranceUnknown status
Hopital Victor Provo
Coordinator of this site? Confirm its status
RoubaixFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.