- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01501656
Epigenetic Testing for Breast Cancer Risk Stratification
Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. The investigators hypothesize that DNA methylation of certain genes occurs as a field change in benign breast tissue that is at high risk for malignant transformation, and as such, can be exploited for tissue-based breast cancer risk stratification. Additional work is required to identify new DNA methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast cancer risk stratification, to determine whether these markers are methylated more frequently in benign samples from women who develop breast cancer, to determine whether assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to better understand the pattern of DNA methylation in benign samples from unselected healthy control populations. Each of these objectives contributes to advancement of a clinically useful RP-FNA-based breast cancer risk stratification test.
In addition, identification of genes that are preferentially methylated in estrogen receptor (ER) negative breast cancer will provide clues to the underlying biology responsible for this aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of ER negative breast cancer, approaches for recognizing women at increased risk for this type of breast cancer, and approaches for reducing this risk.
This study seeks to identify patterns of DNA methylation in benign breast epithelial cells associated with an increased risk for breast cancer with a focus on ER negative breast cancer.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Promoter region hypermethylation of tumor suppressor genes is one the earliest molecular events in malignant transformation and is readily detectable in apparently normal benign breast epithelium adjacent to breast cancers. We hypothesize that DNA methylation of certain genes occurs as a field change in benign breast tissue that is at high risk for malignant transformation, and as such, can be exploited for tissue-based breast cancer risk stratification. Additional work is required to identify new DNA methylation markers potentially useful for periareolar fine needle aspiration (RP-FNA)-based breast cancer risk stratification, to determine whether these markers are methylated more frequently in benign samples from women who develop breast cancer, to determine whether assessment of these markers is reproducible, to determine whether tamoxifen reduces DNA methylation, and to better understand the pattern of DNA methylation in benign samples from unselected healthy control populations. Each of these objectives contributes to advancement of a clinically useful RP-FNA-based breast cancer risk stratification test.
In addition, identification of genes that are preferentially methylated in estrogen receptor (ER) negative breast cancer will provide clues to the underlying biology responsible for this aggressive form of breast cancer. This knowledge may lead to the discovery of the causes of ER negative breast cancer, approaches for recognizing women at increased risk for this type of breast cancer, and approaches for reducing this risk.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Texas
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Dallas, Texas, États-Unis, 75204
- UT Southwestern Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Women between the ages of 30 and 79.
- Untreated stage 1 - 3 invasive breast cancer or a woman never diagnosed with breast cancer.
- BI-RADS 1, 2, or 3 breast imaging within 12 months for women >40 years of age recruited into the control group.
Exclusion Criteria:
- <30 or >80 years of age
- Unable to provide informed consent
- Presence of an undefined palpable or mammographic breast lesion suspicious for malignancy (BIRADS 4 or 5)
- Breast implants
- Bilateral prophylactic mastectomy
- Any prior breasts irradiation
- Any systemic chemotherapy in the past
- Performance status that restricted normal activity for a significant portion of the day
- Use of luteinizing-hormone-releasing-hormone (LHRH) analogs, prolactin inhibitors, antiandrogens, or systemic glucocorticoids within three months
- Ever use of tamoxifen, raloxifene, or other SERMs
- Ever use of aromatase inhibitors
- Pregnancy or lactation within six months
Bleeding diathesis of any kind
- Inherited coagulation disorder
- Current coumadin use
- Use of drugs that inhibit platelet aggregation within 10 days
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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DNA methylation
Délai: 2 years
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This objective assesses methylation of seven genes in 97 archival breast cancer samples.
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Frequency of methylation
Délai: 2 years
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Measure the frequency of methylation of ER positive and ER negative breast cancer-associated genes in benign breast epithelial cells obtained by RP-FNA.
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2 years
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Rolf Brekken, MD, UT Southwetstern Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STU 092011-047
- BC103910 (Autre subvention/numéro de financement: Department of Defense Breast Cancer Research Program)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Essais cliniques sur Cancer du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie