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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
Hodgkin's Disease; Lymphoma

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Study Design

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Study Type :	Observational
Estimated Enrollment :	157 participants
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
Study Start Date :	April 17, 2009
Study Completion Date :	May 26, 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Aisenberg AC. Problems in Hodgkin's disease management. Blood. 1999 Feb 1;93(3):761-79. Review.

Fung HC, Nademanee AP. Approach to Hodgkin's lymphoma in the new millennium. Hematol Oncol. 2002 Mar;20(1):1-15. Review.

AISENBERG AC. HODGKIN'S DISEASE--PROGNOSIS, TREATMENT AND ETIOLOGIC AND IMMUNOLOGIC CONSIDERATIONS. N Engl J Med. 1964 Mar 19;270:617-22 CONCL. Review.

ClinicalTrials.gov Identifier:	NCT00924131 History of Changes
Obsolete Identifiers:	NCT00909246
Other Study ID Numbers:	090127; 09-C-0127
First Posted:	June 18, 2009
Last Update Posted:	July 2, 2017
Last Verified:	May 26, 2010

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