NCT01099020

Brief Summary

The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 6, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 2, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

April 2, 2010

Last Update Submit

May 29, 2015

Conditions

Keywords

Subjects receiving large volumes of Radiation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving large volume of radiation for the treatment of their cancer

You may qualify if:

  • Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
  • Patient must be willing to have blood draws as defined below.
  • Patient must provide study-specific informed consent prior to study entry.
  • Hemoglobin≥8.
  • Age ≥ 18, but not older than age 60.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 6, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 2, 2015

Record last verified: 2015-05

Locations