Breast CancerNCT00858585
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study
An observational study of Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: breast cancer patients
Who may be able to join
- Age at least 18 years of age
- Able to read and sign the informed consent
- Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.
Read the detailed description
Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes
- Conditions
- Breast Cancer
- Keywords
- Bone metastasis, SNP concordance
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Single nucleotide polymorphisms
Determine single nucleotide polymorphism concordances between the three DNA specimen sources
Measured: time-independent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2011
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Van Poznak, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858585
- Sponsor's protocol ID
- UMCC 2008.066
- Other IDs
- HUM 22831
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2009
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer: Concordance Study
- ClinicalTrials.gov ID
- NCT00858585
- Acronym / sponsor ID
- UMCC 2008.066
- Conditions
- Breast Cancer
- Keywords
- Bone metastasis, SNP concordance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Mar 2009 (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.
This study will examine genes in three different tissues and look for similarities and differences between normal cells and cancer cells. The tissues to be studies come from blood, lymph node and cancer.
Detailed description
Subjects will be given an informed consent to read and sign The medical chart will be reviewed for diagnosis and treatment history Blood (about 4 tablespoons) will be drawn at a clinically available time. The lymph node and breast tumor tissue in the University of Michigan pathology repository will be used for research purposes
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- breast cancer patients
Key inclusion criteria (3 listed)
- Age at least 18 years of age
- Able to read and sign the informed consent
- Able to provide specimens: one blood draw for white blood cells, provide permission to use tissue already collected.
Key exclusion criteria (0 listed)
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
Single nucleotide polymorphisms
Time frame: time-independent
Determine single nucleotide polymorphism concordances between the three DNA specimen sources
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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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.
Catherine Van Poznak, MD principal investigator
University of Michigan Rogel Cancer Center
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 Breast Cancer, run by University of Michigan Rogel Cancer Center 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 10 Oct 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Single nucleotide polymorphisms (time frame: time-independent). 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 10 Oct 2019.