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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00026650
• Other study ID #: 000074
• Secondary ID: 00-C-0074
• Status: Recruiting
• Start date: February 14, 2000

Study information

• Verified date: June 3, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Theresa Cooley Zgela, R.N.
• Phone: (301) 451-8905
• Email: tcooley[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

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.

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.

Other known NCT identifiers

• NCT00436813

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the late effects of treatment and the natural history of disease	Description of late effects of radiation treatment and the natural history of diseases being studied.	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page