Breast CancerNCT00897962
Blood Glycan Biomarkers in Women With Stage IV Breast Cancer
An observational study of Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Metastatic Breast Cancer and Non-cancer medical illness
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to 12 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with metastatic breast cancer receiving active chemotherapy, endocrine therapy or targeted therapy Healthy age matched controls without chronic diseases and not on regular prescription medications Patients seen at Internal Medicine Clinic for any reason other than active, metastatic cancer
DISEASE CHARACTERISTICS:
- Patient or participant at the Women's Health Clinic, the Internal Medicine Clinic, or at the UC Davis Cancer Center, meeting 1 of the following criteria:
- Diagnosis of stage IV metastatic breast cancer, receiving active treatment with chemotherapy, endocrine therapy, or targeted therapy
- Patients/participants without cancer
- Healthy control being seen for annual exams, meeting the following criteria:
- No chronic disease
- Not on regular prescribed medications
- Patient without cancer being seen in the Internal Medicine Clinic
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant or breast feeding
- No other active cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Cancer Center
Sacramento, California, 95817
About this study
Official title: Serum Glycan Analysis in Breast Cancer
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer.
Read the detailed description
OBJECTIVES:
- To profile serum glycan biomarkers in women with metastatic stage IV breast cancer, healthy controls, and patients with noncancer medical illness.
- To determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment.
OUTLINE: This is a multicenter study.
Blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. Samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (MALDI) and Fourier transform ion-cyclotron resonance mass spectrometry (FT ICR MS) methods.
Blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. Patients without cancer have a single sample collected.
- Conditions
- Breast Cancer
- Being tested
- Healthy Controls, Metastatic Breast Cancer, Non-cancer medical illness
- Keywords
- stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy ControlsOther
One blood draw (2 teaspoons)
Metastatic Breast CancerOther
Blood samples will be drawn every 3 months, for up to 18 months.
Non-cancer medical illnessOther
One blood draw (2 teaspoons)
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer | Patients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy Receives: Other: Metastatic Breast Cancer | |
| Non-cancer medical illness | Patients with non-cancer medical condition Receives: Other: Non-cancer medical illness | |
| Healthy Controls | Healthy patients being seen for an annual exam Receives: Other: Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness
Measured: up to 18 months
Secondary outcomes (1)
Predictability of serial serum biomarkers in determining disease response and/or progression
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startSep 2006
- Primary completionFeb 2011
- Study completion12 Jan 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 California, DavisThe 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
- Other
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helen K. Chew, MD, Study chair, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897962
- Sponsor's protocol ID
- 234870
- Other IDs
- UCD-186, UCD-200614601, CDR0000583066
- Status last verified
- Dec 2018
- First submitted
- 9 May 2009
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Glycan Analysis in Breast Cancer
- ClinicalTrials.gov ID
- NCT00897962
- Acronym / sponsor ID
- 234870
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- 12 Jan 2016 (actual)
- First posted
- 12 May 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.
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood glycan biomarkers in women with stage IV breast cancer.
Detailed description
OBJECTIVES:
- To profile serum glycan biomarkers in women with metastatic stage IV breast cancer, healthy controls, and patients with noncancer medical illness.
- To determine whether serial serum glycan biomarkers correlate with response of metastatic disease to treatment.
OUTLINE: This is a multicenter study.
Blood is collected from patients with metastatic breast cancer, patients with noncancerous illness, and healthy volunteers. Samples are analyzed for serum glycan biomarkers by matrix-assisted laser desorption/ionization (MALDI) and Fourier transform ion-cyclotron resonance mass spectrometry (FT ICR MS) methods.
Blood samples are collected every 3 months for up to 18 months from patients with metastatic breast cancer. Patients without cancer have a single sample collected.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer | – | Other: Metastatic Breast CancerPatients with metastatic breast cancer receiving treatment with chemotherapy, endocrine therapy or targeted therapy |
| Non-cancer medical illness | – | Other: Non-cancer medical illnessPatients with non-cancer medical condition |
| Healthy Controls | – | Other: Healthy ControlsHealthy patients being seen for an annual exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic breast cancer receiving active chemotherapy, endocrine therapy or targeted therapy Healthy age matched controls without chronic diseases and not on regular prescription medications Patients seen at Internal Medicine Clinic for any reason other than active, metastatic cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy ControlsOne blood draw (2 teaspoons) | Other | Healthy Controls |
| Metastatic Breast CancerBlood samples will be drawn every 3 months, for up to 18 months. | Other | Metastatic Breast Cancer |
| Non-cancer medical illnessOne blood draw (2 teaspoons) | Other | Non-cancer medical illness |
Primary outcome
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness
Time frame: up to 18 months
1 secondary outcome
Predictability of serial serum biomarkers in determining disease response and/or progression
Time frame: Up to 18 months
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 26 Dec 2018.
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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.
Helen K. Chew, MD study chair
University of California, Davis
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 California, Davis 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?
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 26 Dec 2018. 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?
Profiling serum glycan biomarkers in patients with metastatic breast cancer, healthy controls, and patients with noncancer medical illness (time frame: up to 18 months). 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 26 Dec 2018.