Breast CancerNCT01138345
Biomarkers in Blood Samples From Older Breast Cancer Survivors
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, reverse transcriptase-polymerase chain reaction and laboratory biomarker analysis
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis, medical chart review, questionnaire administration
- Keywords
- cancer survivor, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
blood samples will be analyzed for the expression of the p16 gene.
reverse transcriptase-polymerase chain reactionGenetic
perform reverse transcriptase-polymerase chain reaction on all blood samples.
laboratory biomarker analysisOther
perform laboratory biomarker analysis on all blood samples
medical chart reviewOther
perform medical chart review for all subjects
questionnaire administrationOther
each cohort will be given the same questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Treatment w/Surgery | Breast Cancer survivors treated with surgery with or without radiation. Receives: 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. Receives: 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. Receives: Genetic: gene expression analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Other: medical chart review; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
p16INK4a expression between cohort 2 vs cohort 3
Measured: 2 years
p16INK4a expression between cohort 1 vs cohort 2
Measured: 2 years
p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138345
- Sponsor's protocol ID
- LCCC 0924
- Other IDs
- P30CA016086, CDR0000674103
- Status last verified
- Feb 2014
- First submitted
- 4 Jun 2010
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a
- ClinicalTrials.gov ID
- NCT01138345
- Acronym / sponsor ID
- LCCC 0924
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment w/Surgery | – | Genetic: gene expression analysis, Genetic: reverse transcriptase-polymerase chain reaction, Other: laboratory biomarker analysis, Other: medical chart review, Other: questionnaire administrationBreast Cancer survivors treated with surgery with or without radiation. |
| Treatment w/endocrine therapy | – | Genetic: gene expression analysis, Genetic: reverse transcriptase-polymerase chain reaction, Other: laboratory biomarker analysis, Other: medical chart review, Other: questionnaire administrationBreast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. |
| Treatment w/ chemotherapy | – | Genetic: gene expression analysis, Genetic: reverse transcriptase-polymerase chain reaction, Other: laboratory biomarker analysis, Other: medical chart review, Other: questionnaire administrationBreast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer survivors age 50 and older who have completed their breast cancer treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene expression analysisblood samples will be analyzed for the expression of the p16 gene. | Genetic | Treatment w/ chemotherapy, Treatment w/Surgery, Treatment w/endocrine therapy |
| reverse transcriptase-polymerase chain reactionperform reverse transcriptase-polymerase chain reaction on all blood samples. | Genetic | Treatment w/ chemotherapy, Treatment w/Surgery, Treatment w/endocrine therapy |
| laboratory biomarker analysisperform laboratory biomarker analysis on all blood samples | Other | Treatment w/ chemotherapy, Treatment w/Surgery, Treatment w/endocrine therapy |
| medical chart reviewperform medical chart review for all subjects | Other | Treatment w/ chemotherapy, Treatment w/Surgery, Treatment w/endocrine therapy |
| questionnaire administrationeach cohort will be given the same questionnaire | Other | Treatment w/ chemotherapy, Treatment w/Surgery, Treatment w/endocrine therapy |
Primary outcome
p16INK4a expression between cohort 2 vs cohort 3
Time frame: 2 years
p16INK4a expression between cohort 1 vs cohort 2
Time frame: 2 years
p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyman Muss, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
p16INK4a expression between cohort 2 vs cohort 3 (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.