Abnormalities, Radiation-InducedNCT00652678
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
An observational study of Abnormalities, Radiation-Induced, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 years and older, women only
- Conditions the study is for
- Abnormalities, Radiation-Induced
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 years and older
- Women only
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Reconstructive surgery to involved breast
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
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.
Read the 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.
- Conditions
- Abnormalities, Radiation-Induced
- Keywords
- Breast cancer, Radiation effects
- Medical subject headings
- Abnormalities, Radiation-Induced, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject
Measured: at least 2.5 years following lumpectomy and radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startAug 2006
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormalities, Radiation-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Carol M. Baldwin Breast Cancer Research Fund, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter J Hahn, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652678
- Sponsor's protocol ID
- Project # 1050425
- Status last verified
- Sep 2013
- First submitted
- 1 Apr 2008
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00652678
- Acronym / sponsor ID
- Project # 1050425
- Conditions
- Abnormalities, Radiation-Induced
- Keywords
- Breast cancer, Radiation effects
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 38 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Carol M. Baldwin Breast Cancer Research Fund, Inc.
- Study start
- Aug 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 48 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Reconstructive surgery to involved breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject
Time frame: at least 2.5 years following lumpectomy and radiation therapy
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J Hahn, PhD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormalities, Radiation-Induced, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of the results obtained from the three blood tests with the clinical assessments of cosmetic outcome for each subject (time frame: at least 2.5 years following lumpectomy and radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.