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

Cancer Clinical Trial

Official title: Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy

Status Recruiting

Clinical Trial 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 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.

Clinical Trial Description

BACKGROUND

• This protocol acknowledges that it is in the interest of the NIH and ROB, as well as our participants, 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 participants previously treated with radiotherapy in the Radiation Oncology Branch (ROB).

ELIGIBILITY

-Participants who received radiation therapy at the NCI and are not enrolled 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 participants receiving standard of care long-term follow up care and evaluation, including NIH consultation services as required.

• It will be made clear to participants 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. ;

Related Conditions & MeSH terms

• Cancer

• NCT number: NCT00026650
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Theresa Cooley Zgela, R.N.
• Phone: (301) 451-8905
• Email: tcooley@mail.nih.gov
• Status: Recruiting
• Start date: February 14, 2000