Biomarkers in Blood Samples From Older Breast Cancer Survivors

NCT01138345 | Completed DMC

• 3 other identifiers: LCCC 0924P30CA016086CDR0000674103
• Study Type: observational
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

cancer survivor; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (3)

• p16INK4a expression between cohort 2 vs cohort 3

  2 years

• p16INK4a expression between cohort 1 vs cohort 2

  2 years

• p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4

  2 years

Study Arms (3)

Treatment w/Surgery

Breast Cancer survivors treated with surgery with or without radiation.

Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Other: medical chart review; Other: questionnaire administration

Treatment w/endocrine therapy

Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy.

Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Other: medical chart review; Other: questionnaire administration

Treatment w/ chemotherapy

Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy.

Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Other: medical chart review; Other: questionnaire administration

Interventions

gene expression analysis GENETIC

blood samples will be analyzed for the expression of the p16 gene.

Treatment w/ chemotherapy; Treatment w/Surgery; Treatment w/endocrine therapy

reverse transcriptase-polymerase chain reaction GENETIC

perform reverse transcriptase-polymerase chain reaction on all blood samples.

Treatment w/ chemotherapy; Treatment w/Surgery; Treatment w/endocrine therapy

laboratory biomarker analysis OTHER

perform laboratory biomarker analysis on all blood samples

Treatment w/ chemotherapy; Treatment w/Surgery; Treatment w/endocrine therapy

medical chart review OTHER

perform medical chart review for all subjects

Treatment w/ chemotherapy; Treatment w/Surgery; Treatment w/endocrine therapy

questionnaire administration OTHER

each cohort will be given the same questionnaire

Treatment w/ chemotherapy; Treatment w/Surgery; Treatment w/endocrine therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression Profiling; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Hyman Muss, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2010
• First Posted: June 7, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2014
• Last Updated: February 27, 2014

Record last verified: 2014-02

Locations

US (1)