Neurologic Morbidity and Disability in Acute Lymphoblastic Leukemia Survivors

NCT00664131 | Completed

• 1 other identifier: ALLNOQ
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of acute lymphoblastic leukemia achieves high cure rate, but is potentially neurotoxic. Long-term neurologic morbidity in survivors and its effect on function are inadequately studied. Neurologic outcomes will be assessed through an investigator administered questionnaire followed by comprehensive neurologic examination by the study neurologist.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic Leukemia; ALL survivors; ALL neurologic symptoms; ALL neurologic disability; ALL late effects

Outcome Measures

Primary Outcomes (2)

• To estimate prevalence of neurologic symptoms as reported by the patient or parent in childhood acute lymphoblastic leukemia survivors.

  At lease 5 years from diagnosis and at least one year after completion of therapy.

• To estimate prevalence of neurologic signs as determined by detailed neurologic examination of childhood acute lymphoblastic leukemia survivors.

  At lease 5 years from diagnosis and at least one year after completion of therapy.

Secondary Outcomes (3)

• To estimate prevalence of neurologic disability as determined by neurologic symptoms, signs and administered questionnaire instruments.

  At lease 5 years from diagnosis and at least one year after completion of therapy.

• To explore risk factors for development of neurologic disability.

  At lease 5 years from diagnosis and at least one year after completion of therapy.

• To assess effect of neurologic disability on quality of life.

  At lease 5 years from diagnosis and at least one year after completion of therapy.

Study Arms (1)

1

Other: Neurological Examination/Questionnaires

Interventions

Neurological Examination/Questionnaires OTHER

See Detailed Description section for description of treatment plan.

1

Eligibility Criteria

• Age: 6 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Survivors of ALL who are currently 6-28 years of age, 5 years from ALL diagnosis, and 1 year off therapy who were treated on institutional protocols at St. Jude Children's Research Hospital. Survivors will be recruited in the Leukemia and ACT clinics at St. Jude Children's Research Hospital. We anticipate that 494 survivors are available. We plan to enroll every survivor who is eligible and visits Leukemia or/ and ACT clinic at St. Jude Children's Research Hospital

You may qualify if:

• Childhood ALL survivors treated on institutional protocols at
• Patient will be at least 5-years from ALL diagnosis.
• Patient will be at least one year from completion of cancer therapy.
• Absence of recurrent or secondary cancer for at least one year day of enrollment.
• Between 6-28 years of age at the time of evaluation.
• Patient's or at least one parent's English is proficient enough Questionnaire.
• Parent and the child agree to participate. Consent only from will suffice if \> 18 years of age at the time of assessment.

You may not qualify if:

• Recurrent tumor or development of secondary cancer
• Child or parent refuses to participate
• Co-morbid pre-existing disabling neurologic disease, which in the judgment of the principal investigator may compromise clinical observations.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kirsten Ness, PT, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: April 22, 2008
• Study Start: August 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 23, 2011

Record last verified: 2011-09

Locations

US (1)