- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02455882
Tissue Procurement Protocol for Patients Undergoing Treatment for Early-Stage Breast Cancer
Through the investigators' Breast Care Center at the University of Michigan Comprehensive Cancer Center, the investigators treat approximately 75 patients per year with neoadjuvant chemotherapy. The majority of the remainder of patients with stage II and III disease undergo treatment with adjuvant chemotherapy either on a clinical protocol or as standard of care. There is a subset of women with ER positive disease who do not receive chemotherapy because of favorable tumor characteristics.
This tissue procurement protocol is designed to systematically collect tissue, urine and blood specimens on patients undergoing neoadjuvant systemic therapy or adjuvant chemotherapy, serially following treatment, and/or at the time of disease recurrence in order to investigate mechanisms underlying development of metastatic disease, to identify predictors of response and resistance to therapy, and to test potential new therapies for breast cancer using a combination of patient-derived xenograft creation and new microfluidic technologies.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Comprehensive Cancer Center
-
-
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
Entry Criteria for patients receiving neoadjuvant or adjuvant therapy (groups 1 and 2)
Inclusion Criteria
- All patients must have a primary invasive breast cancer with the primary tumor intact (T2-4, any N, any M). Inflammatory breast cancer is permitted.
- For the neoadjuvant cohort (group 1), the patient's clinical plan includes neoadjuvant systemic therapy (chemotherapy, hormonal therapy, and/or biologic therapy) prior to surgery on the breast.
- For the adjuvant cohort (group 2), the patient's clinical plan includes surgical resection of the primary breast mass followed by adjuvant chemotherapy (with or without endocrine therapy or biologic therapy such as trastuzumab).
- Patients in the neoadjuvant cohort must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
- All patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan IRB standards.
Exclusion Criteria - For the neoadjuvant cohort (group 1): Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave at least 2 cm of measurable disease by physical examination, mammography, or ultrasound (with the exception of inflammatory breast cancer)
- For the adjuvant cohort (group 2): Tumors diagnosed by excisional or incisional biopsy and which are not likely to have at least 2 cm of residual tumor remaining
- Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
- Patients with another active systemic malignancy within the past year.
Entry Criteria for patients with newly diagnosed locoregional or distant disease recurrence (who did not enroll at the time of initial adjuvant or neoadjuvant chemotherapy) (group 3)
Inclusion Criteria
- Patients must have been previously diagnosed with non-invasive or invasive breast cancer.
- Patients must have been diagnosed with biopsy-proven recurrence of breast cancer at any site
- All patients are required to sign an informed consent document regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan IRB standards.
Exclusion Criteria
- Patients must not have received any chemotherapy, hormonal therapy, or radiation therapy for treatment of their recurrent breast cancer.
- Patients must not have been diagnosed with another active systemic malignancy within the past year.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
---|
Neoadjuvant
Patients initiating standard of care treatment with primary systemic therapy for breast cancer
|
Adjuvant
Patients initiating standard of care treatment with surgery followed by adjuvant chemotherapy for breast cancer
|
Recurrence
Patients with a history of breast cancer who are diagnosed with disease recurrence
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Collection of samples for analysis of somatic mutations
Délai: 5 years
|
Mutations in the tumor before and after primary systemic therapy will be examined
|
5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Collection of samples for analysis of circulating biomarkers
Délai: 5 years
|
Change in circulating biomarkers, including extracellular DNA and RNA, over time will be examined
|
5 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Erin F Cobain, MD, University of Michigan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- HUM00084633
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer du sein
-
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