- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00899496
Laboratory Assay in Determining Cancer Resistance in Patients With Metastatic Cancer and in Healthy Participants
Pilot Study of Cancer Resistance in Humans
RATIONALE: Studying samples of blood and tissue in the laboratory from patients with cancer and from healthy participants may help doctors learn more about cancer.
PURPOSE: This laboratory study is looking at an assay in determining cancer resistance in patients with metastatic cancer and in healthy participants.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Optimize and standardize the in vitro cell kill assay using human white blood cells and human cancer cell lines from patients with metastatic cancer and from healthy participants.
- Determine the results of the in vitro cell kill assay in patients with metastatic cancer and in healthy participants with no history of cancer.
OUTLINE: This is a pilot study.
Peripheral blood is obtained from healthy participants and from cancer patients. Tissue is collected from archived samples. White blood cells are obtained from tissue and blood samples and are assessed by the in vitro cell kill assay.
PROJECTED ACCRUAL: A total of 24 patients and 24 healthy participants will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
-Meets 1 of the following criteria:
Diagnosis of metastatic cancer including, but not limited to, any of the following:
- Stage IV non-small cell lung cancer
- Extensive-stage small cell lung cancer
- Metastatic testicular cancer
- Stage IV breast carcinoma
- Stage III or IV ovarian carcinoma
- Stage IV endometrial carcinoma
- Stage IV prostate carcinoma
- Stage IV colorectal or pancreatic cancer
- Stage IV renal cancer
- Stage III or IV non-Hodgkin's lymphoma
- Stage IV bladder cancer
- Stage III multiple myeloma (Salmon-Durie staging)
- Metastatic melanoma
- Metastatic sarcoma
Healthy participant, meeting the following criteria:
- No prior cancer
- Over 50 years of age
Exclusion Criteria:
- Serious medical or psychiatric condition that would preclude study compliance
- Chemotherapy or radiotherapy within the past 3 months (patient)
- Prior immunosuppressive therapy or radiotherapy for any disease (healthy participant)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Cell killing ability (positive or negative)
Tidsramme: Day 180
|
Day 180
|
|
Percentage of cells killed
Tidsramme: Day 180
|
Day 180
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Zheng Cui, PhD, Wake Forest University Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
- stadium IV nyrecellekræft
- stadium III malign testikel-kimcelletumor
- stadium IV brystkræft
- småcellet lungekræft i omfattende stadie
- stadium IV blærekræft
- stadium IV prostatacancer
- fase IV ikke-småcellet lungekræft
- uspecificeret voksen solid tumor, protokol specifik
- stadium IV endetarmskræft
- stadium IV tyktarmskræft
- stadium III ovarieepitelkræft
- stadium IV ovarieepitelkræft
- stadium III voksent diffust storcellet lymfom
- stadium III voksen immunoblastisk storcellet lymfom
- stadium III voksen Burkitt lymfom
- stadium IV grad 3 follikulært lymfom
- stadium IV voksent diffust storcellet lymfom
- stadium IV voksen immunoblastisk storcellet lymfom
- stadium IV voksen Burkitt lymfom
- stadium IV melanom
- fase IV kræft i bugspytkirtlen
- Waldenstrom makroglobulinæmi
- stadium III voksent diffust små spaltet celle lymfom
- stadium III voksent diffust blandet celle lymfom
- stadium IV grad 1 follikulært lymfom
- stadium IV grad 2 follikulært lymfom
- stadium IV voksent diffust små spaltet celle lymfom
- stadium IV voksent diffust blandet celle lymfom
- stadium III mantelcellelymfom
- stadium IV mantelcellelymfom
- stadium III myelomatose
- stadium III lille lymfatisk lymfom
- stadium III marginal zone lymfom
- stadium IV lille lymfocytisk lymfom
- stadium IV marginal zone lymfom
- ekstranodal marginal zone B-celle lymfom af slimhinde-associeret lymfoid væv
- nodal marginal zone B-celle lymfom
- milt marginal zone lymfom
- stadium IV endometriekarcinom
- primært non-Hodgkin lymfom i centralnervesystemet
- stadium III kutant T-celle non-Hodgkin lymfom
- stadium IV kutant T-celle non-Hodgkin lymfom
- stadium III voksen lymfoblastisk lymfom
- stadium IV voksen lymfoblastisk lymfom
- stadium III voksen T-celle leukæmi/lymfom
- stadium IV voksen T-celle leukæmi/lymfom
- intraokulært lymfom
- angioimmunoblastisk T-celle lymfom
- anaplastisk storcellet lymfom
- stadium III mycosis fungoides/Sezary syndrom
- stadium IV mycosis fungoides/Sezary syndrom
- voksen grad III lymfomatoid granulomatose
- voksen nasal type ekstranodal NK/T-celle lymfom
- kutant B-celle non-Hodgkin lymfom
- stadium IV bløddelssarkom hos voksne
- stadium IV uterin sarkom
- ovariesarkom
- metastatisk osteosarkom
Andre undersøgelses-id-numre
- CCCWFU 95A05
- P30CA012197 (U.S. NIH-bevilling/kontrakt)
- CCCWFU-99A05
- CCCWFU-BG05-342
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med fysiologisk test
-
John SappNova Scotia Health Authority; Rochester Institute of TechnologyRekrutteringMyokardieinfarkt | Ventrikulær takykardiCanada
-
Yale UniversityTravera IncRekrutteringPeritoneale metastaser | Kolorektalt adenokarcinom | BlindtarmskræftForenede Stater
-
Institute of Oncology LjubljanaAfsluttetCandidæmi | Invasiv candidiasisSlovenien
-
Sied KebirMünster University Hospital, GermanyRekrutteringGlioblastoma Multiforme, voksen | Glioblastom, voksen | Glioblastom eller GliosarkomTyskland
-
University of North Carolina, Chapel HillEnvironmental Protection Agency (EPA)SuspenderetSund og raskForenede Stater
-
Icahn School of Medicine at Mount SinaiChildren's Hospital of PhiladelphiaRekruttering
-
Northwestern UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...AfsluttetDiabetes mellitus under graviditetForenede Stater
-
Ballad HealthRekrutteringLungekræft (NSCLC)Forenede Stater
-
St. Olavs HospitalNorwegian University of Science and TechnologyAfsluttetTakykardi, Ventrikulær | Defibrillatorer, implanterbareNorge
-
Massachusetts Eye and Ear InfirmaryCenters for Disease Control and PreventionRekruttering