Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01305954
Recruitment Status : Active, not recruiting
First Posted : March 1, 2011
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date February 17, 2011
First Posted Date March 1, 2011
Last Update Posted Date April 30, 2020
Study Start Date December 2010
Actual Primary Completion Date April 3, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2011)
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ]
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 25, 2011)
  • Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ]
    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 ]
    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 ]
    To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
Official Title LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 25, 2011)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Actual Primary Completion Date April 3, 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01305954
Other Study ID Numbers LCCC1027
10-2121 ( Other Identifier: UNC Office of Human Research Ethics )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Hyman Muss, MD University of North Carolina
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date April 2020