Predictive Blood Tests for Severe Radiation Reactions in... | NCT00652678

Studies
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

NCT00652678

Sponsor

State University of New York - Upstate Medical University

Status

Terminated

Last Update Posted

Oct 22, 2021Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Abnormalities, Radiation-Induced

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

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 4, 2008Estimated

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

Oct 19, 2021

Last Update Posted Date

Oct 22, 2021Actual

Name	Class
Carol M. Baldwin Breast Cancer Research Fund, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

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

Retention

Enrollment

38Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Reconstructive surgery to involved breast

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter J Hahn, PhD	State University of New York - Upstate Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Upstate Medical University		Syracuse	New York	13210	United States

Condition Browse Module

MeSH Terms

ID	Term
D000016	Abnormalities, Radiation-Induced
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D011832	Radiation Injuries
D014947	Wounds and Injuries

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Browse Branches

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