Protocol Number: 09-C-0127

Title:

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

Number:

09-C-0127

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Late Effects

Radiation

Chemotherapy

Hodgkin's Disease

Lymphoma

Recruitment Keyword(s):

Hodgkin Disease

Lymphoma

Condition(s):

Hodgkin's Disease

Lymphoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

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

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

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

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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