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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01305954
First received: February 17, 2011
Last updated: February 26, 2014
Last verified: February 2014

February 17, 2011
February 26, 2014
December 2010
December 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01305954 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.

Breast Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01305954
LCCC1027, 10-2121
Yes
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
Not Provided
Principal Investigator: Hyman Muss, MD University of North Carolina
UNC Lineberger Comprehensive Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP