Breast CancerNCT00897728
Study of Tumor and Blood Samples From Women With Breast Cancer
An observational study of Breast Cancer, run by Institut Curie at 1 site in France.
Trial summary
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- laboratory biomarker analysis
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Feb 2010
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of infiltrating unilateral breast cancer
- No in situ disease (ductal or lobular)
- No invasive bilateral synchronous disease
- Breast cancer at high risk, defined by at least 2 of the following factors:
- Hormone receptor negative (HR-)
- Axillary node positive
- Histopathologic grade III
- High mitotic index (as defined by the Curie Institute as > 20 mitoses per 10 high-power fields [HPF])
- Tumor size ≥ 2 cm
- HER2-positive (3 + IHC or FISH/ICHS positive)
- Triple-negative tumors (HR- and HER2-negative)
- Initial thoracic-abdomino-pelvic and bone scans must be negative
- Underwent initial surgery
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
- No other invasive cancer within the past 5 years
- Not pregnant or nursing
- No psychological, familial, social, or geographical reasons that make monitoring impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Curie Hopital
Paris, 75248
Paul-Henri Cottu, 33-3-8393-5005
About this study
Official title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.
Secondary
- Evaluate all relapses.
- Assess survival without relapse.
- Determine correlation between biomarkers and relapse.
OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.
- Conditions
- Breast Cancer
- Being tested
- laboratory biomarker analysis
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, HER2-positive breast cancer, triple-negative breast cancer, estrogen receptor-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis
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 startFeb 2008
- Primary completionFeb 2010 (estimated)
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.
- 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
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Investigators
- Paul-Henri Cottu, Study chair, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897728
- Sponsor's protocol ID
- CDR0000599189
- Other IDs
- CLCC-IC-COBRED-SEIN, CLCC-IC-2007-11, CLCC-RECF0632
- Status last verified
- Jul 2009
- First submitted
- 9 May 2009
- Last updated
- 1 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.
- ClinicalTrials.gov ID
- NCT00897728
- Acronym / sponsor ID
- CDR0000599189
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, HER2-positive breast cancer, triple-negative breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (estimated)
- 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 tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.
Detailed description
OBJECTIVES:
Primary
- Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.
Secondary
- Evaluate all relapses.
- Assess survival without relapse.
- Determine correlation between biomarkers and relapse.
OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
Primary outcome
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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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.
Paul-Henri Cottu study chair
Institut Curie
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 Institut Curie at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 1 Dec 2010. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis. 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 1 Dec 2010.