Biomarkers in Blood Samples From Older Breast Cancer Survivors
26 février 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
246
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Breast cancer survivors age 50 and older who have completed their breast cancer treatment.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Treatment w/Surgery
Breast Cancer survivors treated with surgery with or without radiation.
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blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
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.
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blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
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.
|
blood samples will be analyzed for the expression of the p16 gene.
perform reverse transcriptase-polymerase chain reaction on all blood samples.
perform laboratory biomarker analysis on all blood samples
perform medical chart review for all subjects
each cohort will be given the same questionnaire
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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p16INK4a expression between cohort 2 vs cohort 3
Délai: 2 years
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2 years
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p16INK4a expression between cohort 1 vs cohort 2
Délai: 2 years
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2 years
|
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p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4
Délai: 2 years
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2 years
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2010
Achèvement primaire (Réel)
1 janvier 2013
Achèvement de l'étude (Réel)
1 février 2014
Dates d'inscription aux études
Première soumission
4 juin 2010
Première soumission répondant aux critères de contrôle qualité
4 juin 2010
Première publication (Estimation)
7 juin 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
27 février 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 février 2014
Dernière vérification
1 février 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCCC 0924
- P30CA016086 (Subvention/contrat des NIH des États-Unis)
- CDR0000674103 (Autre identifiant: PDQ number)
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