Biomarkers in Blood Samples From Older Breast Cancer Survivors

February 26, 2014 updated by: UNC Lineberger Comprehensive Cancer Center

The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
p16INK4a expression between cohort 2 vs cohort 3
Time Frame: 2 years
2 years
p16INK4a expression between cohort 1 vs cohort 2
Time Frame: 2 years
2 years
p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 4, 2010

First Submitted That Met QC Criteria

June 4, 2010

First Posted (Estimate)

June 7, 2010

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 0924
  • P30CA016086 (U.S. NIH Grant/Contract)
  • CDR0000674103 (Other Identifier: PDQ number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on gene expression analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe