NCT00652678

Brief Summary

Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 22, 2021

Status Verified

September 1, 2013

Enrollment Period

6 years

First QC Date

April 1, 2008

Last Update Submit

October 19, 2021

Conditions

Abnormalities, Radiation-Induced

Keywords

Breast cancerRadiation effects

Outcome Measures

Primary Outcomes (1)

  • correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject

    at least 2.5 years following lumpectomy and radiation therapy

Eligibility Criteria

Age48 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential study subjects will be drawn from patients with a history of treatment for breast cancer with lumpectomy followed by radiation therapy.

You may qualify if:

  • Breast cancer treatment: lumpectomy followed by external beam XRT to breast
  • Age at the time of radiotherapy treatment: 45-65 years old
  • XRT dose to breast: \>/= 4500 and \</= 5200 cGy, fraction size 180 or 200 cGy
  • Dose distribution: no area receiving \>/= 112% of prescribed dose
  • Follow-ups: patients must be \>/= 2.5 years post-treatment

You may not qualify if:

  • Reconstructive surgery to involved breast

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood mononuclear cells

MeSH Terms

Conditions

Abnormalities, Radiation-InducedBreast Neoplasms

Condition Hierarchy (Ancestors)

Congenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Peter J Hahn, PhD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

August 1, 2006

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 22, 2021

Record last verified: 2013-09

Locations

US(1)