Breast CancerNCT00896857
Studying Cells Collected Through Ductal Lavage in Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer
An observational study of Breast Cancer, run by Wake Forest University Health Sciences.
Trial summary
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- RNA analysis, polymerase chain reaction and protein expression analysis
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Feb 2008
- 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 Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast Cancer
DISEASE CHARACTERISTICS:
- Agrees to undergo breast surgical procedure AND meets one of the following criteria:
- Scheduled to undergo breast biopsy based on suspicious mammographic or clinical breast examination findings
- Diagnosis of ductal carcinoma in situ (DCIS) or carcinoma in the breast to be studied (opposite breast may also be studied)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Pre- or post-menopausal
- Not currently pregnant or pregnant within the past 12 months
- Must not have lactated within the past 12 months
- No active infection or inflammation in the breast to be studied
- No known allergy to lidocaine, prilocaine, or marcaine (bupivacaine)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior subareolar surgery or other breast procedure that may disrupt the ductal system within 2 cm of the nipple in the breast to be studied
- No prior breast implant that disrupts the ductal architecture in the breast to be studied
- No prior silicone injections in the breast to be studied
- No prior radiotherapy to the breast to be studied
- No chemotherapy within the past 6 months
- Concurrent prophylactic chemotherapy allowed
- No concurrent participation in another research study that may conflict with or affect the outcome of this study
About this study
Official title: Breast Cancer Prevention by Inducing Apoptosis in DCIS Using Breast Ductal Lavage
RATIONALE: Studying samples of tissue 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 laboratory study is evaluating cells collected through ductal lavage in women undergoing surgery for ductal carcinoma in situ or other breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in primary DCIS cell cultures.
- Determine the expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in cells obtained by breast ductal lavage.
OUTLINE: Patients undergo breast lavage to collect primary epithelial cells for cytological analysis before a planned surgical procedure. Ductal carcinoma in situ (DCIS) tissue samples obtained from surgery are used to establish primary DCIS cell cultures. The DCIS cells and primary epithelial cells obtained by ductal lavage are analyzed for endogenous protein levels of bcl-2, bax, and bcl-xL, using western blotting and immunohistochemical staining, to determine the appropriate antisense oligonucleotide molecule that will be used to induce apoptosis. The DCIS cells and primary epithelial cells obtained by ductal lavage are treated with antisense oligonucleotides and/or a physiological chemopreventive dose of tamoxifen citrate to determine which will provide the highest induction of cell death. The effect of these treatments on protein expression is analyzed by western blotting and immunohistochemistry. The effect of these treatments on markers of programed cell death (PCD) (i.e., DNA fragmentation and caspase activation) is also analyzed. Changes in mRNA expression are analyzed using a PCR-based quantitation assay.
Results from the molecular marker assays are not provided to the patients.
- Conditions
- Breast Cancer
- Being tested
- RNA analysis, polymerase chain reaction, protein expression analysis, reverse transcriptase-polymerase chain reaction, western blotting
- Keywords
- breast cancer, ductal breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA analysisGenetic
polymerase chain reactionGenetic
protein expression analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
western blottingGenetic
immunoenzyme techniqueOther
laboratory biomarker analysisOther
breast duct lavageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in primary DCIS cell cultures
Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in cells obtained by breast ductal lavage
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 startApr 2004
- Primary completionFeb 2008
- Study completionFeb 2008
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 Wake Forest University Health SciencesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Patrick P. Koty, PhD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896857
- Sponsor's protocol ID
- CCCWFU-74A04
- Other IDs
- CDR0000579246, CCCWFU-BG04-063
- Status last verified
- Mar 2017
- First submitted
- 9 May 2009
- Last updated
- 15 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Prevention by Inducing Apoptosis in DCIS Using Breast Ductal Lavage
- ClinicalTrials.gov ID
- NCT00896857
- Acronym / sponsor ID
- CCCWFU-74A04
- Conditions
- Breast Cancer
- Keywords
- breast cancer, ductal breast carcinoma in situ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2004 (actual)
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (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 tissue 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 laboratory study is evaluating cells collected through ductal lavage in women undergoing surgery for ductal carcinoma in situ or other breast cancer.
Detailed description
OBJECTIVES:
- Determine the expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in primary DCIS cell cultures.
- Determine the expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage.
- Determine whether down-regulation by genetic manipulation of the anti-apoptotic genes bcl-2 and/or bcl-xL, alone or in conjunction with physiological preventive doses of tamoxifen citrate, has the highest induction of PCD in cells obtained by breast ductal lavage.
OUTLINE: Patients undergo breast lavage to collect primary epithelial cells for cytological analysis before a planned surgical procedure. Ductal carcinoma in situ (DCIS) tissue samples obtained from surgery are used to establish primary DCIS cell cultures. The DCIS cells and primary epithelial cells obtained by ductal lavage are analyzed for endogenous protein levels of bcl-2, bax, and bcl-xL, using western blotting and immunohistochemical staining, to determine the appropriate antisense oligonucleotide molecule that will be used to induce apoptosis. The DCIS cells and primary epithelial cells obtained by ductal lavage are treated with antisense oligonucleotides and/or a physiological chemopreventive dose of tamoxifen citrate to determine which will provide the highest induction of cell death. The effect of these treatments on protein expression is analyzed by western blotting and immunohistochemistry. The effect of these treatments on markers of programed cell death (PCD) (i.e., DNA fragmentation and caspase activation) is also analyzed. Changes in mRNA expression are analyzed using a PCR-based quantitation assay.
Results from the molecular marker assays are not provided to the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women Undergoing Surgery for Ductal Carcinoma In Situ or Other Breast 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 |
|---|---|---|
| RNA analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| protein expression analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| western blotting | Genetic | – |
| immunoenzyme technique | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| breast duct lavage | Procedure or surgery | – |
Primary outcome
Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in primary DCIS cell cultures
Expression pattern of the PCD regulatory genes bcl-2, bax, and bcl-xL in cells obtained by breast ductal lavage
Induction of PCD by antisense oligonucleotides and/or tamoxifen citrate in cells obtained by breast ductal lavage
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 15 Mar 2017.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Patrick P. Koty, PhD study chair
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Wake Forest University Health Sciences.
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 15 Mar 2017. 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?
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?
Expression pattern of the programmed cell death (PCD) regulatory genes bcl-2, bax, and bcl-xL in primary ductal carcinoma in situ (DCIS) cultures. The study lists 4 primary outcomes in all. 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 15 Mar 2017.