Follow Up of Patients Treated With Radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00026650
First received: November 14, 2001
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition
Cancer
Late Effects

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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. [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2000
Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00026650

Contacts
Contact: Sharon L Smith, R.N. (301) 451-8905 smiths@mail.nih.gov
Contact: Kevin A Camphausen, M.D. (301) 496-5457 camphauk@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT00026650     History of Changes
Obsolete Identifiers: NCT00436813
Other Study ID Numbers: 000074, 00-C-0074
Study First Received: November 14, 2001
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Late Effects
Radiation Therapy
Cancer

ClinicalTrials.gov processed this record on August 28, 2014