Evaluation of Late Effects and Natural History of Disease... | NCT00026650

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

NCT00026650

Sponsor

National Cancer Institute (NCI)

Status

Recruiting

Last Update Posted

Jul 2, 2026Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
00-C-0074

Status Module

Record Verification Date

Jun 23, 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2000Actual

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 14, 2001

First Submission Date that Met QC Criteria

Nov 14, 2001

First Posted Date

Nov 15, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 2, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1/Cohort 1		Patients who have received radiotherapy in the ROB and may or may not be officially entered on a clinical protocol.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who received radiation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rukayat O Salau	Contact	(240) 858-3712		rukayat.salau@nih.gov
Kevin A Camphausen, M.D.	Contact	(240) 760-6205		camphauk@mail.nih.gov

Overall Officials

Name	Affiliation	Role
Kevin A Camphausen, M.D.	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center	Recruiting	Bethesda	Maryland	20892	United States

Label	URL
NIH Clinical Center Detailed Web Page	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IPD recorded in the medical record will be shared with intramural investigators upon request.

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided