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

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ClinicalTrials.gov Identifier: NCT00026650
Recruitment Status : Recruiting
First Posted : November 15, 2001
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.

Condition or disease
Cancer

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
Actual Study Start Date : February 14, 2000

Group/Cohort
1/Cohort 1
Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol.



Primary Outcome Measures :
  1. Assessment of the late effects of treatment and the natural history of disease [ Time Frame: Ongoing ]
    Description of late effects of radiation treatment and the natural history of diseases being studied.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received radiation
Criteria
  • 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.


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
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Contact: Theresa Cooley-Zgela, R.N. (240) 764-6207 theresa.cooleyzgela@nih.gov
Contact: Kevin A Camphausen, M.D. (240) 760-6205 camphauk@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Kevin A Camphausen, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026650    
Obsolete Identifiers: NCT00436813
Other Study ID Numbers: 000074
00-C-0074
First Posted: November 15, 2001    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 19, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Late Effects
Radiation Therapy
Cancer
Natural History