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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00026650
Collaborator
(none)
700
1

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Feb 14, 2000

    Arms and Interventions

    Arm Intervention/Treatment
    1/Cohort 1

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

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of the late effects of treatment and the natural history of disease [Ongoing]

      Description of late effects of radiation treatment and the natural history of diseases being studied.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kevin A Camphausen, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00026650
    Other Study ID Numbers:
    • 000074
    • 00-C-0074
    • NCT00436813
    First Posted:
    Nov 15, 2001
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Jul 25, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)

    Study Results

    No Results Posted as of Aug 25, 2022