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Biomarkers in Blood Samples From Older Breast Cancer Survivors

26. februar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

246

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
Genetisk: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetisk: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Andet: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Andet: medical chart review
perform medical chart review for all subjects
Andet: 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.
Genetisk: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetisk: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Andet: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Andet: medical chart review
perform medical chart review for all subjects
Andet: 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.
Genetisk: gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
Genetisk: reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.
Andet: laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
Andet: medical chart review
perform medical chart review for all subjects
Andet: questionnaire administration
each cohort will be given the same questionnaire

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
p16INK4a expression between cohort 2 vs cohort 3
Tidsramme: 2 years
2 years
p16INK4a expression between cohort 1 vs cohort 2
Tidsramme: 2 years
2 years
p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Samarbejdspartnere

National Cancer Institute (NCI)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. februar 2014

Datoer for studieregistrering

Først indsendt

4. juni 2010

Først indsendt, der opfyldte QC-kriterier

4. juni 2010

Først opslået (Skøn)

7. juni 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LCCC 0924
  • P30CA016086 (U.S. NIH-bevilling/kontrakt)
  • CDR0000674103 (Anden identifikator: PDQ number)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Brystkræft

Kliniske forsøg med gene expression analysis

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bangladesh

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner