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

NCT00026650 | Recruiting

• 2 other identifiers: 00007400-C-0074
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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. ELIGIBILITY
• Participants who received radiation therapy. DESIGN
• This is a natural history protocol in which long-term follow up data will be collected from participants who received radiation therapy.
• 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.

Conditions

Cancer

Keywords

Late Effects; Radiation Therapy; Cancer; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1/Cohort 1

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received radiation

You may qualify if:

• 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.
• Age greater than or equal to 18 years of age

You may not qualify if:

• Participants who are on an interventional research protocol at NIH at the time of enrollment.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rukayat O Salau

CONTACT

(240) 858-3712; rukayat.salau@nih.gov

Kevin A Camphausen, M.D.

CONTACT

(240) 760-6205; camphauk@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2001
• First Posted: November 15, 2001
• Study Start: February 14, 2000
• Last Updated: July 16, 2026

Record last verified: 2026-07-14

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)