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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

00-C-0074

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Late Effects;
Radiation Therapy;
Cancer;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

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 disparate 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.

Objective:

-The primary objective of this protocol is to assess the late effects of treatment and the natural history of disease through collection of data from any standard procedures performed as part of follow up care on patients previously treated with radiotherapy in the Radiation Oncology Branch (ROB).

Eligibility:

-Patients who received radiation therapy at the NCI and are not entered on an interventional research protocol at the time of enrollment.

Design:

-This is a natural history protocol in which data will be collected from Radiation Oncology Branch patients receiving standard of care 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 during their follow-up may be used anonymously for publications concerning the natural history of disease processes and long-term effects of treatment.

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Eligibility

INCLUSION CRITERIA:

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

Participant is able to provide informed consent.

Participant 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 participants who lack health insurance, etc.

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

Age greater than or equal to 18 years of age

EXCLUSION CRITERIA:

Participants who are on an interventional research protocol at NIH at the time of enrollment.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kevin A. Camphausen, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3675
10 CENTER DR
BETHESDA MD 20892
(240) 760-6205
camphauk@mail.nih.gov

Theresa Cooley Zgela, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2-5530
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8905
tcooley@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT00026650

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