Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
This study is currently recruiting participants.
Verified January 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01305954
First received: February 17, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer |
Resource links provided by NLM:
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]To measure and correlate baseline p16INK4a expression in subjects with stage I-IV breast cancer starting a new course of chemotherapy with a post cycle 1 chemotherapy absolute neutrophil count (ANC).
Secondary Outcome Measures:
- Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.
- Explore the Associations between p16INK4a Expression at Baseline and Other Chemotherapy-Related Toxicities including Nausea and Vomiting, Neuropathy, Fatigue and Other Grade 3 and 4 Toxicities [ Time Frame: 24 Months ] [ Designated as safety issue: No ]To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.
- Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function [ Time Frame: 24 months ] [ Designated as safety issue: No ]To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.
Biospecimen Retention: Samples With DNA
Blood samples
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.
Criteria
Inclusion Criteria:
- ≥ 18 years of age;
- Histologically confirmed Stage I-IV breast cancer;
- ECOG Performance Status 0-3;
- Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
- Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
- Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
- Signed, IRB approved written informed consent.
Exclusion Criteria:
- Presence of acute, active infection;
- History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
- Other co-morbid illness which would impair ability to participate in the study;
- Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
- Prior or current receipt of histone deacetylase (HDAC) inhibitors
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305954
Contacts
| Contact: Shani Alston, MPH | 9198431906 | shani_alston@med.unc.edu |
Locations
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Hyman Muss, MD | |
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
| Principal Investigator: | Hyman Muss, MD | University of North Carolina |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01305954 History of Changes |
| Other Study ID Numbers: | LCCC1027, 10-2121 |
| Study First Received: | February 17, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
Breast Cancer Breast Cancer New Diagnosis Treatment Chemotherapy Blood Blood Draw Lab Draw |
Gene Gene Therapy Geriatric Oncology Muss UNC North Carolina Cancer Hospital Initial Treatment CBC |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013