NCT00167427

Brief Summary

The purpose of the research study is to evaluate an automated, laser-based technique for measuring DNA damage caused by radiation during cancer treatment in immature red blood cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

17.9 years

First QC Date

September 9, 2005

Last Update Submit

March 5, 2024

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Measure the Change in MN-RET in the blood

    Baseline and 1 day

Eligibility Criteria

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

Patients that are scheduled to begin radiotherapy to the large-field chest region

You may qualify if:

  • Patients that are scheduled to begin radiotherapy to the large-field chest region are eligible if:
  • Daily radiation dose is between 1.8 and 5 Gy/day
  • Any single dimension of field size is ≥ 15 cm
  • Provision of written informed consent
  • Or patients receiving IMRT or Tomotherapy, when low-dose radiation is spread out to the normal tissues, irrespective of daily radiation doses.
  • Or patients receiving radionucleotides as part of the medical treatment (cancer or non-malignant conditions)
  • Or patients who will receive diagnostic CT scans, PET/CT scans, mammograms, or diagnostic imaging requiring radionucleotides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester, Dept. Radiation Oncology

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Yuhchyau Chen, MD, Ph.D

    Universtiy of Rochester, Dept of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigatory

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

April 1, 2006

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations

US(1)