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A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

4. oktober 2012 oppdatert av: Precision Therapeutics

A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

While studies support the clinical use of ChemoFx® in cancer patients, additional data are needed to further assess the utilization of this product in clinical practice. Such post-market data and information could be employed for product improvement as well as for the development of standards and regulations. This is a multicenter registry study of 3,000 patients with solid tumors. The study is not randomized, nor is it interventional in that the treating physician is free to choose how to employ ChemoFx® results in the clinical management of individual patients. Sites will be selected by Precision's clinical trials team based on past commercial usage of ChemoFx®.

Subjects who may be enrolled in this study are those who have been diagnosed with a solid tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the normal commercial process and is therefore billed to the patient's medical insurance.

All subjects will be appropriately consented before any study-specific data are collected. A limited dataset of patient demographics, oncology history, and therapeutic intervention will be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the medical judgment of their treating physician(s). Patient survival data will be collected up to five years following the ChemoFx® commercial order. Additional disease progression data may be collected by Precision's CRAs at participating sites.

Optional Cell Research

Informed consent will be obtained to document subject's consent to use excess cells remaining in Precisions' commercial laboratory for additional research. This portion of the study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject, any identifiers that would link the sample to the subject will be removed. The samples would then have gene expression profiling and or quantitative protein expression analysis performed. The goal of the research would be to identify a set of informative genes, intermediaries, and proteins and develop predictive algorithm(s) that seek to link the expression level of the gene, gene signature, intermediary, or protein to the clinical outcome of the patient. This portion of the study does not require any additional subject procedures. Neither physicians nor their patients will receive the results of the research performed. Results will not be placed in the subjects health care records and will not affect their medical care.

Studietype

Observasjonsmessig

Registrering (Faktiske)

167

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35213
        • Cardio-Thoracic Surgeons, P.C.
    • California
      • Oakland, California, Forente stater, 94609
        • Hematology Oncology Associates
    • Florida
      • Boynton Beach, Florida, Forente stater, 33435
        • Collaborative Research Group
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Broward Oncology Associates, P.A.
      • Hollywood, Florida, Forente stater, 33021
        • The Center For Gynecologic Oncology
      • Miami, Florida, Forente stater, 33143
        • GYN Oncology of Miami
      • Miami, Florida, Forente stater, 33173
        • Miami International Surgical Services
      • Orlando, Florida, Forente stater, 32804
        • Orlando Cardiovascular Institute PA
    • Illinois
      • Skokie, Illinois, Forente stater, 60076
        • Edward H. Kaplan, M.D. & Associates
    • Iowa
      • Des Moines, Iowa, Forente stater, 50309
        • Iowa Clinic
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40503
        • Central Baptist Hospital Clinical Research Center
      • Paducah, Kentucky, Forente stater, 42003
        • Oncology Associates of West Kentucky
    • Michigan
      • Grand Blanc, Michigan, Forente stater, 48439
        • Grand Blanc Surgical Specialist
    • New York
      • Albany, New York, Forente stater, 12208
        • Albany Thoracic & Esophageal Surgery
      • East Setauket, New York, Forente stater, 11733
        • North Shore Hematology Oncology
      • Flushing, New York, Forente stater, 11355
        • The New York Hospital Medical Center of Queens
      • Mineola, New York, Forente stater, 11501
        • Winthrop University Hospital
    • Ohio
      • Cleveland, Ohio, Forente stater, 44106
        • Center for Clinical Research and Technology University Hospitals of Cleveland
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16505
        • The Regional Cancer Center
    • Texas
      • Houston, Texas, Forente stater, 77090
        • Northwest Cancer Center
      • Houston, Texas, Forente stater, 77054
        • Colorectal Surgical Associates
      • Houston, Texas, Forente stater, 77024
        • Barry S Siller MD
      • San Antonio, Texas, Forente stater, 78229
        • Cancer Care Centers of South Texas
    • Washington
      • Spokane, Washington, Forente stater, 99202
        • Cancer Care Northwest
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26508
        • Heiskell, King, Burns & Tallman Surgical Associates, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Subjects with solid tumor malignancies

Beskrivelse

Inclusion Criteria:

  • Pathologically confirmed diagnosis of solid tumor malignancy;
  • Medically indicated to receive chemotherapy;
  • Fresh tissue submitted from the solid tumor malignancy for testing with the ChemoFx® assay after August, 2006;
  • Final ChemoFx® assay report is available;
  • Subject must be at least 18 years of age;
  • Subject must sign and date an IRB approved ICF.

Exclusion Criteria:

  • Enrolled in PT-103, PT-106, PT-206, PT-301, or PT-304;
  • Pregnant or lactating subjects;
  • Subjects are not indicated to receive chemotherapy for their disease;
  • Subjects with psychiatric or addictive disorders that would preclude obtaining informed consent.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
To determine physicians' rate of compliance with ChemoFx assay results in the treatment of subjects with solid tumors.
Tidsramme: Analysis of assay-directed compliance will be conducted immediately after information is collected.
Analysis of assay-directed compliance will be conducted immediately after information is collected.
To investigate the association between the results of Precision's ChemoFx assay results and overall survival in subjects with solid tumors.
Tidsramme: From date of first dose of on-study chemotherapy to date of death or last known alive.
From date of first dose of on-study chemotherapy to date of death or last known alive.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Precision Therapeutics

Etterforskere

  • Hovedetterforsker: Karl Williams, M.D., Precision Therapeutics, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2010

Primær fullføring (Faktiske)

1. oktober 2012

Studiet fullført (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først innsendt

5. januar 2011

Først innsendt som oppfylte QC-kriteriene

6. januar 2011

Først lagt ut (Anslag)

7. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. oktober 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. oktober 2012

Sist bekreftet

1. oktober 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PT-207

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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