Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial
Condition: Hodgkin's Disease; Lymphoma
MeSH terms: Hodgkin Disease
Study type: Observational

Summary: 
      Background:

        -  Researchers are greatly interested in knowing more about the long-term effects of
           various treatments for cancers such as Hodgkin's disease, particularly from those who
           have lived 20 to 30 years after treatment.

        -  Patients who were treated at the National Institutes of Health (NIH) may have undergone
           different treatments for which more long-term information is needed.

      Objectives:

        -  To examine the body systems of long-term survivors of Hodgkin's disease to see if there
           are any long- term consequences of treatment for Hodgkin's disease.

        -  To learn more about the long-term effects of cancer treatments.

      Eligibility:

        -  Survivors of Hodgkin's disease who were previously treated at the NIH.

        -  Participants must be at least 18 years of age.

      Design:

        -  Participants will need to sign consent forms to allow researchers to obtain
           documentation of medical history, including prior treatment for Hodgkin's disease and
           prior NIH treatment, including protocol number, where applicable:

        -  Pertinent medical records, pathology reports, and radiographic imaging studies will be
           reviewed.

        -  Primary care physician's name, address, and other contact information are also required.

        -  Evaluations during the assessment period:

        -  Complete physical examination.

        -  Laboratory studies of blood, urine, and stool samples.

        -  Radiologic evaluations, including computerized tomography (CT) and magnetic resonance
           imaging (MRI) scans for all participants and mammograms for females.

        -  Cardiac evaluation, vascular studies, and pulmonary studies to measure heart and lung
           function, and digestive tests to measure stomach and intestinal function.

        -  Neurocognitive testing to measure brain function.

        -  Optional skin biopsy.

        -  Participants will be asked to complete questionnaires assessing current quality of life
           and daily living skills.
    

Detailed description: 
      BACKGROUND:

      Nearly 75% of Hodgkin's Disease (HD) patients can be cured of their disease with chemotherapy
      and radiotherapy, resulting in a growing number of long-term survivors.

      Adverse effects of HD treatments, including second malignancies and cardiovascular disease,
      affect survival and quality of life. Minimizing late toxicities has become a major emphasis
      of current and investigational regimens.

      Better characterization of long-term toxicity and quality of life (QOL) after therapy for HD
      and the ability to determine which late toxicities arise from a given modality may allow an
      ability to shape future regimens such that late toxicity can be minimized.

      OBJECTIVES:

      Primary objectives:

      To describe the cardiac, pulmonary, and vascular function in patients previously treated for
      HD at NIH and to correlate this information to the treatment received.

        -  To measure cardiac function and abnormalities and to correlate these findings with
           treatment received.

        -  To measure pulmonary function with pulmonary function testing in survivors of HD and to
           correlate these findings with treatment received.

        -  To measure vascular function in survivors of HD and to correlate these findings with
           treatment received.

      Secondary Objectives:

      To determine if elevated plasma TGF levels correlate with the presence of late radiation
      fibrosis in long-term survivors of HD.

      To evaluate late quality of life (QOL) in long-term survivors of HD and to correlate QOL with
      treatment received.

      To evaluate and describe additional exploratory measures of organ function in patients
      previously treated for HD at NIH and to correlate this information to the treatment received.

        -  Heart rate variability

        -  Pulmonary fibrosis.

        -  Intestinal function.

        -  Neurocognitive function.

      To evaluate the correlation of exploratory functional assays, biomarkers, and single
      nucleotide polymorphisms with the presence of late chemotherapy or radiation toxicity in
      long-term HD survivors.

      ELIGIBILITY:

      Survivors of HD previously treated at the NIH.

      DESIGN:

      This is a single point in time follow-up evaluation of long-term HD survivors, previously
      treated at the NIH.

      Patients will be evaluated for late toxicities in multiple organ systems using imaging
      modalities, laboratory tests, functional assays, and investigational studies.
    

Time perspective: Other
Keywords: Late Effects; Radiation; Chemotherapy; Hodgkin's Disease; Lymphoma; Hodgkin Disease