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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Kevin A Camphausen, M.D.; Phone Number: (240) 760-6205; Email: camphauk@mail.nih.gov
• Study Contact Backup: Name: Theresa Cooley Zgela, R.N.; Phone Number: (301) 451-8905; Email: tcooley@mail.nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received radiation

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2000

Study Registration Dates

• First Submitted: November 14, 2001
• First Submitted That Met QC Criteria: November 14, 2001
• First Posted (Estimated): November 15, 2001

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: September 27, 2023

More Information

Terms related to this study

• Keywords: Cancer; Natural History; Radiation Therapy; Late Effects
• Other Study ID Numbers: 000074; 00-C-0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No