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

NCT ID: NCT00026650

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Late Effects Radiation Therapy Cancer Natural History

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1/Cohort 1

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin A Camphausen, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Theresa C Cooley Zgela, R.N.

Role: CONTACT

Phone: (301) 451-8905

Email: [email protected]

Kevin A Camphausen, M.D.

Role: CONTACT

Phone: (240) 760-6205

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00-C-0074

Identifier Type: -

Identifier Source: secondary_id

000074

Identifier Type: -

Identifier Source: org_study_id

NCT00436813

Identifier Type: -

Identifier Source: nct_alias