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Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00924131
First received: June 17, 2009
Last updated: June 30, 2017
Last verified: May 26, 2010
  Purpose

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.

Condition
Hodgkin's Disease Lymphoma

Study Type: Observational
Study Design: Time Perspective: Other
Official Title: Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 157
Study Start Date: April 17, 2009
Estimated Study Completion Date: May 26, 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Inclusion Criteria for all Participants:

  • Patients must be at least 18 years of age 15
  • Patients must have been previously treated for Hodgkin's Disease at the NIH
  • Patient must be willing to complete quality of life questionnaires and to answer questions regarding their medical history
  • Patient must be willing to provide release of medical information forms for physicians and hospitals involved in their management

Inclusion Criteria for Evaluation at NIH/NIA:

In addition to those above,

  • Patient is willing to return to NIH/NIA to participate in the protocol
  • Patient must have a primary physician in the community who is willing to communicate with NIH regarding clinical findings and collaborate in the clinical management and follow-up of the patient. This will be substantiated by communicating directly with the patient's physician prior to evaluation.
  • Pregnant patients are eligible for follow up evaluations and quality of life evaluations. They will be excluded for any radiological testing and invasive studies. Any blood draws will be approved by the patient's obstetrician and if any of the laboratory tests to be performed have been carried out within the last three months, those values will be used instead of repeating them. Alternatively, pregnant patients may choose to participate in the study after the birth of their child to be able to participate in the full evaluation.

EXCLUSION CRITERIA:

  • Inability to give informed consent
  • Patients, and/ or guardians who are in the estimation of the PI, deemed unable or unlikely to adhere to protocol evaluations and follow-up requirements.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924131

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00924131     History of Changes
Obsolete Identifiers: NCT00909246
Other Study ID Numbers: 090127
09-C-0127
Study First Received: June 17, 2009
Last Updated: June 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Late Effects
Radiation
Chemotherapy
Hodgkin's Disease
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2017