Protocol Number: 00-C-0074

Title:

Evaluation of Late Effects and Natural History of Disease in Patients Treated with Radiotherapy

Number:

00-C-0074

Summary:

Background:

-This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our patients, to continue to follow those who have been treated with radiotherapy at ROB and are not otherwise eligible for current active research protocols. it also provides a mechanism for the correlation and interpretation of disparatc data for research into the long term side effects and outcomes for a variety of disease entities and treatments, such as combined modality treatment, MoAb, PDT, radiation modifiers, intraoperative radiotherapy, etc.

Objectives:

-The objective of this protocol is to provide follow-up care for patients previously treated with radiotherapy in the Radiation Oncology Branch (ROB) in order to assess the late effects of treatment and the natural history of disease.

Eligibility:

-Patients who received radiation therapy at the NCI IRB who are long-term survivors and are not currently entered on an active research protocol.

Design:

-This is a natural history protocol that will provide follow-up care for Radiation Oncology Branch patients and will allow for appropriate long-term follow up care and evaluation, including NIH consultation services as required. It will be made clear to patients in the consent form, that data collected in their follow-up may be used anonymously for publications concerning the natural history of disease processes and long term effects of treatment.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Radiation Oncology Branch investigator deems that it is in the best interests of the patient and the NCI/ROB for the patient to be seen in follow-up in the ROB clinic.

Patient or guardian is able to provide informed consent.

Patient must have a primary physician in the community to whom records and appropriate follow-up management can be given. Social services will be enlisted for any patients who lack health insurance, etc.

Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol. Some patients treated prior to 1993 may not have been officially entered on a clinical protocol.

EXCLUSION CRITERIA:

Patients who are on another active primary research protocol at NIH.

Special Instructions:

Currently Not Provided

Keywords:

Follow-Up

Long-Term

Radiation

Side-Effects

Therapy

Recruitment Keyword(s):

None

Condition(s):

Neoplasm

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): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 01/30/2009