- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00897468
Developing Mouse Models of Breast Cancer Using Tissue Samples From Women With Breast Cancer
Developing In-Vivo Models of Human Breast Cancer
RATIONALE: Changing the genes in laboratory mice to create a living model of human breast cancer may help doctors learn more about breast cancer.
PURPOSE: This research study is developing mouse models of breast cancer using tissue samples that were previously collected from women with breast cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- To develop new in vivo models of human breast cancer.
- To correlate response in this model to actual treatment outcome in patients, if the in vivo model is proven feasible.
OUTLINE: Previously collected breast tumor fragments are implanted into the renal capsule site of SCID mouse hosts (mouse with severe combined immune deficiency) to establish metastatic spread patterns, and both histologic and molecular tumor characteristics.
Patients' medical charts are reviewed to obtain relevant information, including general demographics, smoking and alcohol use, as well as outcome data such as survival and response to treatment.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
- Any stage of disease
- Primary or metastatic disease
- Human breast tumor tissues available after the diagnoses have been made
Enrolled on the ongoing Breast Tissue Repository trial VU-VICC-BRE-03103
- Have consented to the use of their tissues for research purpose
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
breast cancer patients
|
Tissue samples will either be collected at the time of medically indicated surgical procedures or through research core biopsies.
A sample of urine will also be obtained.
Blood will be collected via venipuncture and lymphocytes (mononuclear cells) separated and processed as a source of normal DNA and normal cells.
patient chart review will occur in conjunction with patient data collection for final analyses.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Development of new in vivo models of human breast cancer
Tidsramme: 1 year
|
1 year
|
|
Correlation of response in this model to actual treatment outcome in patients, if the in vivo model proven feasible
Tidsramme: 5 years
|
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VICC BRE 0704
- P30CA068485 (U.S. NIH-bevilling/kontrakt)
- VU-VICC-BRE-0704
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