Breast CancerNCT00898690
Gene Expression in Predicting Response to Paclitaxel in Patients With Breast Cancer
An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
Trial summary
RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment. PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cytogenetic analysis, gene expression analysis and microarray analysis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to not given
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Measurable disease
- Metastatic disease identified by imaging studies OR a primary disease site that will be treated in a neoadjuvant protocol
- Lesions ≥ 10 mm by spiral CT scan
- Tumor tissue from the primary or metastatic site available for analysis by immunohistochemistry
- Previously treated OR planning to undergo treatment with paclitaxel* NOTE: *Concurrent enrollment on ECOG-2100 allowed
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
RATIONALE: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment.
PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.
Read the detailed description
OBJECTIVES:
- Determine whether loss of function of the FEZ1/LZTS1 gene is a predictor of response in patients with breast cancer treated with paclitaxel.
OUTLINE: This is a single-blind study.
Tumor tissue is analyzed for FEZ1/LZTS1 gene expression by immunohistochemistry using an antibody for the gene. Tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. Tumor tissue is also analyzed for FEZ1/LZTS1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- cytogenetic analysis, gene expression analysis, microarray analysis, mutation analysis, reverse transcriptase-polymerase chain reaction
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent 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.
cytogenetic analysisGenetic
gene expression analysisGenetic
microarray analysisGenetic
mutation analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
Secondary outcomes (1)
Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)
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 startMar 2003
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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Carlo M. Croce, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898690
- Sponsor's protocol ID
- CDR0000355163
- Other IDs
- TJUH-02U.536
- Status last verified
- May 2006
- First submitted
- 9 May 2009
- Last updated
- 18 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of FEZ1/LZTS1 Expression As A Predictor Of Response To Taxol
- ClinicalTrials.gov ID
- NCT00898690
- Acronym / sponsor ID
- CDR0000355163
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- 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: DNA analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment.
PURPOSE: This laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.
Detailed description
OBJECTIVES:
- Determine whether loss of function of the FEZ1/LZTS1 gene is a predictor of response in patients with breast cancer treated with paclitaxel.
OUTLINE: This is a single-blind study.
Tumor tissue is analyzed for FEZ1/LZTS1 gene expression by immunohistochemistry using an antibody for the gene. Tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. Tumor tissue is also analyzed for FEZ1/LZTS1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| cytogenetic analysis | Genetic | – |
| gene expression analysis | Genetic | – |
| microarray analysis | Genetic | – |
| mutation analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| immunohistochemistry staining method | Other | – |
Primary outcome
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel
1 secondary outcome
Utility of FEZ1/LZTS1 gene expression in predicting the full 4-level response pattern (complete response, partial response, stable disease, progressive disease)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
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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.
Carlo M. Croce, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Evaluation of the association between tumor expression of FEZ1/LZTS1 gene and response to paclitaxel. 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 18 Dec 2013.