NCT06116929

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
May 2024Jan 2028

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

October 31, 2023

Last Update Submit

February 26, 2024

Conditions

Hodgkin Disease

Keywords

Hodgkin DiseaseChemotherapyFunctional and Cognitive Assessment

Outcome Measures

Primary Outcomes (1)

  • Computerized Speed Cognitive Test (CSCT)

    The CSCT will be used to evaluate the impact of Chemotherapy +/- radiotherapy treatment on the attentional abilities of HD cases, immediately after the end of treatment, and at a distance from this treatment. The CSCT score is calculated as follows: The patient has 90 seconds to orally state the correspondence of numbers (from 1 to 9) to 9 different symbols (matched according to a correspondence standard). The number of correct answers is measured (maximum score of 120).

    12 months

Secondary Outcomes (8)

  • Brief Visual-spatial Memory Test-Revised

    12 months

  • D2-R

    12 months

  • Trail Making test

    12 months

  • Functional Assessment of Cancer Therapy- Cognitive Function (FACT-Cog)

    12 months

  • Hospital Anxiety and Depression scale (HAD)

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Patients with Hodgkin's disease

OTHER
Other: Morphological and functional magnetic resonance imaging (MRI)Other: Neuropsychological assessment

Controls without Hodgkin's disease

OTHER
Other: Morphological and functional magnetic resonance imaging (MRI)Other: Neuropsychological assessment

Interventions

Morphological and functional magnetic resonance imaging (MRI)OTHER

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.

Controls without Hodgkin's diseasePatients with Hodgkin's disease
Neuropsychological assessmentOTHER

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.

Controls without Hodgkin's diseasePatients with Hodgkin's disease

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).
  • Claustrophobia preventing MRI from being performed
  • Contraindication to MRI
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Artois Ternois

Arras, France

Location

Hôpital Claude Huriez

Lille, France

Location

Hôpital Saint-Philibert

Lomme, France

Location

Hôpital Victor Provo

Roubaix, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Sandy AMORIM

    Onco-Hematology Department-Hôpital Saint Vincent de Paul-GHICL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Paule LEBITASY

CONTACT

03.20.22.57.41Lebitasy.Marie-Paule@ghicl.net

Marie Desolere

CONTACT

033 320225931desolere.marie@ghicl.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 3, 2023

Study Start

May 15, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)