We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow Up of Patients Treated With Radiotherapy

This study is currently recruiting participants.
Verified August 17, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026650
First Posted: November 15, 2001
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy

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

Primary Outcome Measures:
  • 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. [ Time Frame: Ongoing ]

Estimated Enrollment: 600
Study Start Date: February 7, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

Age greater than or equal to 18 years of age

EXCLUSION CRITERIA:

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026650


Contacts
Contact: Theresa Cooley-Zgela, R.N. (240) 760-6207 theresa.cooleyzgela@nih.gov
Contact: Kevin A Camphausen, M.D. (240) 760-6205 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026650     History of Changes
Obsolete Identifiers: NCT00436813
Other Study ID Numbers: 000074
00-C-0074
First Submitted: November 14, 2001
First Posted: November 15, 2001
Last Update Posted: October 19, 2017
Last Verified: August 17, 2017

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