- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01096394
Collection of Tissue Samples From Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Orthotopic Propagation of Primary Human Ovarian Tumors for Preclinical Investigation of Novel Anti-Tumor Agents.
RATIONALE: Collecting and storing samples of tumor tissue and ascites fluid from patients to test in the laboratory may help the study of cancer.
PURPOSE: This pre-clinical research study is collecting tissue samples and ascites fluid from patients with stage III or stage IV ovarian/primary peritoneal/fallopian tube epithelial cancer.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- To generate a translational ovarian cancer model using tumor tissue and cells from patients with stage III-IV ovarian/primary peritoneal/fallopian tube epithelial cancer for drug response and development.
OUTLINE: Tissue and fluid samples are collected at the time of surgery or paracentesis and used in laboratory experiments and in animal models. Health data is collected from patient medical records before, during, and after surgery.
After surgery, patients are followed up for 5 years.
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
INCLUSION:
• Females age 18-80 with a diagnosis of Stage III-IV ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma and scheduled treatment for epithelial ovarian malignancies.
EXCLUSION:
- Patients with less than Stage III epithelial ovarian cancer, primary fallopian tube, or primary peritoneal papillary serous carcinoma
- Patients who have received prior chemotherapy
- Patients who have nonepithelial ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma
- Patients who have malignancy other than ovarian cancer, primary fallopian tube, or primary peritoneal carcinoma
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Ovarian cancer
Patients with presumed Stage III-IV ovarian, primary fallopian tube, or primary peritoneal papillary serous carcinoma.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Establishment of a "live" library of primary ovarian epithelial tumors
Tidsramme: 5 year follow up of outcome.
|
Our approach is to establish a "live" library of primary tumors from patients diagnosed with ovarian cancer by transplanting this tissue into a host mouse model.
This preclinical model system will allow us to test the response to standard and novel therapeutics and will provide a perpetual tumor archive for future experiments that will probe critical molecular pathways involved in the pathogenesis of ovarian cancer and similar cancer types (primary peritoneal and fallopian tube).
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5 year follow up of outcome.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dineo Khabele, MD, Vanderbilt-Ingram Cancer Center
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Genitale neoplasmer, kvindelige
- Sygdomme i det endokrine system
- Ovariesygdomme
- Adnexale sygdomme
- Gonadale lidelser
- Neoplasmer i endokrine kirtler
- Ovariale neoplasmer
- Karcinom, ovarieepitel
Andre undersøgelses-id-numre
- 090075
- P30CA068485 (U.S. NIH-bevilling/kontrakt)
- VU-VICC-GYN-0917 (Anden identifikator: Vanderbilt Ingram Cancer Center)
- IRB# 090075 (Anden identifikator: Vanderbilt University Human Protections Program)
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