Biomarkers in Blood Samples From Older Breast Cancer Survivors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01138345
First received: June 4, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in blood samples from older women with stage I, stage II, or stage III breast cancer who have finished primary therapy or breast cancer survivors.


Condition Intervention Phase
Breast Cancer
Genetic: gene expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Other: medical chart review
Other: questionnaire administration
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • p16INK4a expression between cohort 2 vs cohort 3 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • p16INK4a expression between cohort 1 vs cohort 2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Enrollment: 246
Study Start Date: January 2010
Study Completion Date: February 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
Genetic: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetic: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Other: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Other: medical chart review
perform medical chart review for all subjects
Other: questionnaire administration
each cohort will be given the same questionnaire
Treatment w/endocrine therapy
Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.
Genetic: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetic: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Other: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Other: medical chart review
perform medical chart review for all subjects
Other: questionnaire administration
each cohort will be given the same questionnaire
Treatment w/ chemotherapy
Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy.
Genetic: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetic: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Other: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Other: medical chart review
perform medical chart review for all subjects
Other: questionnaire administration
each cohort will be given the same questionnaire

Detailed Description:

OBJECTIVES:

Primary

  • To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy followed by endocrine therapy (cohort 2) versus surgery with or without radiotherapy followed by chemotherapy and with or without endocrine therapy (cohort 3) .
  • To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy (cohort 1) versus women treated in cohort 2.
  • To compare normalized p16^INK4a gene expression between cohorts 1, 2, and 3 versus an age-matched contemporaneous control group of healthy volunteers accrued from a separate study (cohort 4).

Secondary

  • To access functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, nutritional status, and health-behavior status of these patients.

Tertiary (exploratory)

  • To compare methodologies of p16 ^INK4a gene expression measurement in 50 patients in order to develop a batchable and analytically validated assay that eliminates the need for rapid sample processing.
  • To explore any association between p16^INK4a expression and amount of vigorous physical activity, smoking habits, and/or weekly alcohol consumption.
  • To explore any association between p16^INK4a expression and type of chemotherapy received, co-morbidities, concomitant medications, and/or tumor characteristics.
  • To correlate p16^INK4a expression with scores from selected domains of the Geriatric Assessment (i.e., cognitive function, activities of daily living (ADL), and the instrumental ADL.

OUTLINE: Breast cancer survivors and healthy volunteers undergo blood collection for p16^INK4a gene expression analysis by Taqman RT-PCR.

Breast cancer survivors complete the Health Behavior and the Geriatric Assessment Questionnaires. They also complete a Timed Up and Go test to determine physical mobility.

Medical charts are reviewed to record information about diagnosis and treatment.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Breast cancer survivors age 50 and older who have completed their breast cancer treatment.

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Stage I-III disease
  • Breast cancer survivors meeting 1 of the following criteria:

    • Prior surgery with or without (±) radiotherapy (RT) (cohort 1)
    • Prior surgery ± RT, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)

      • Must have received or be on endocrine therapy for ≥ 3 months
    • Prior surgery ± RT, followed by prior chemotherapy ± endocrine therapy (cohort 3)
  • No recurrent disease
  • No history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)

PATIENT CHARACTERISTICS:

  • Life expectancy > 12 months
  • Absolute lymphocyte count > 500/μL
  • No acute or active infection
  • No other co-morbid illness that would impair ability to participate in the study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 months since prior surgery with or without radiotherapy
  • At least 3 months since prior chemotherapy (cohort 3)
  • No concurrent radiotherapy, chemotherapy, or experimental therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138345

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Hyman Muss, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01138345     History of Changes
Other Study ID Numbers: LCCC 0924, P30CA016086, CDR0000674103
Study First Received: June 4, 2010
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
cancer survivor
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014