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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2023-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers in Blood Samples From Older Breast Cancer Survivors

NCT01138345

Breast Cancer

COMPLETED

Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

NCT00003854

Breast Cancer

COMPLETED PHASE3

Long-Term Follow-Up in Women With Early Breast Cancer Three Years of More Post Primary Treatment

NCT05926024

Breast Cancer

ACTIVE_NOT_RECRUITING

Molecular Marker Profiling of Axillary Lymph Nodes in Predicting Response in Patients With Locally Advanced or Metastatic Breast Cancer Who Are Undergoing Chemotherapy Followed By Surgery

NCT00233974

Breast Cancer

COMPLETED PHASE2

Establishment of Normal Breast Epithelial Cell Lines From Patients at High Risk for Breast Cancer

NCT00001496

Breast Neoplasm Hereditary Neoplastic Syndrome

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No