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ChemoFx® PRO - A Post-Market Data Collection Study

4. oktober 2012 opdateret af: Precision Therapeutics

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2756

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
      • Mobile, Alabama, Forenede Stater, 36688
        • University of South Alabama
    • California
      • San Francisco, California, Forenede Stater, 94115
        • University of California San Francisco
      • Sherman Oaks, California, Forenede Stater, 91403
        • Women's Cancer Center of Southern California
      • Torrance, California, Forenede Stater, 91403
        • GOA Torrance Memorial
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Hartford Hospital
      • New Haven, Connecticut, Forenede Stater, 06111
        • Yale University
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33487
        • South Florida Center for Gynecologic Oncology
      • Clearwater, Florida, Forenede Stater, 33756
        • West Coast Gynecologic Oncology
      • Coconut Creek, Florida, Forenede Stater, 33073
        • Florida Center for Gynecologic Oncology
      • Delray Beach, Florida, Forenede Stater, 33444
        • Comprehensive Gynecologic Oncology
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Caruso and Gates MDs PA
      • Fort Myers, Florida, Forenede Stater, 33901
        • Florida Gynecologic Oncology
      • Hollywood, Florida, Forenede Stater, 33021
        • Gynecologic Oncology Associates
      • Sarasota, Florida, Forenede Stater, 34239
        • Sarasota Memorial Hospital
      • South Miami, Florida, Forenede Stater, 33143
        • South Miami Gynecologic Oncology Group
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Riverdale, Georgia, Forenede Stater, 30274
        • Southeastern Gynecologic Oncology, LLC
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • The Queens' Medical Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University
      • Evanston, Illinois, Forenede Stater, 60201
        • Northshore Medical Group
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University
    • Louisiana
      • Covington, Louisiana, Forenede Stater, 70433
        • Women's Cancer Center
      • Shreveport, Louisiana, Forenede Stater, 71101
        • CHRISTUS Schumpert Health System
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Sinai Hospital
      • Silver Springs, Maryland, Forenede Stater, 20852
        • Women's Health Specialists
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01605
        • UMass Memorial Hospital
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Health System
      • Grand Rapids, Michigan, Forenede Stater, 49546
        • Gynecologic Oncology of West Michigan
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • Mississippi Oncology Associates
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07962
        • Atlantic Health Systems
      • Neptune, New Jersey, Forenede Stater, 07765
        • Jersey Shore University Medical Center
      • Teaneck, New Jersey, Forenede Stater, 07066
        • Gara M Sommers MD
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cooper Health System
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Women's Cancer Care Associates
      • Atlantic Beach, New York, Forenede Stater, 11509
        • St. John's Episcopal Hospital
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • Manhassett, New York, Forenede Stater, 11030
        • North Shore Lij Health System
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
      • New York, New York, Forenede Stater, 10038
        • New York Downtown Hospital
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28806
        • Hope: A Women's Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Blumenthal Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28233
        • Presbyterian Gynecologic Oncology
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Wilmington, North Carolina, Forenede Stater, 28402
        • North Hanover Regional Medical Center
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45267
        • University of Cincinnati
      • Columbus, Ohio, Forenede Stater, 43026
        • OSU Gynecologic Oncology
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Oklahoma Gynecologic Oncology Group
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • The Western Pennsylvania Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Allegheny-Singer Research Institute
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Women & Infants Hospital of Rhode Island
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29403
        • Medical University of South Carolina Hospital
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Sandford USD Health System
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Chattanooga's Program In Women's Oncology
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Chattanooga Gynecologic Oncology
      • Knoxville, Tennessee, Forenede Stater, 37922
        • Thomas W. McDonald MD
    • Texas
      • Dallas, Texas, Forenede Stater, 75251
        • North Texas Gynecologic Oncology
      • Ft. Sam Houston, Texas, Forenede Stater, 78234
        • Brooke Army Medical Center
      • San Antonio, Texas, Forenede Stater, 78258
        • South Texas Gynecologic Oncology
    • Virginia
      • Annandale, Virginia, Forenede Stater, 22003
        • North Virigina Pelvic Surgery Associates
      • Roanoke, Virginia, Forenede Stater, 24016
        • Carilion Clinic Gynecologic Oncology
    • West Virginia
      • Morgantown, West Virginia, Forenede Stater, 26505
        • Mohammed Ashraf MD
    • Wisconsin
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Aurora West Allis Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Approximately 3,000 patients from 150 academic and community based physicians in the United States.

Patients have a confirmed solid tumor malignancy and their tissue specimen has been submitted to Precision Therapeutics, Inc. as part of the patient's medical care

Beskrivelse

Inclusion Criteria:

  • Patient has been diagnosed with a solid tumor malignancy and their physician has received a final report for ChemoFx® after August 1, 2006
  • Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
  • Patient must be at least 18 years of age
  • Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.

Exclusion Criteria:

  • Patient pathology shows benign pathology for sample submitted
  • Patient is not indicated to receive chemotherapy for their disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To collect physician reported outcomes after the first chemotherapy utilized following the receipt of a final report from ChemoFx® in solid tumor malignancies for the generation of hypotheses for further sub-study.
Tidsramme: 24-36 Months depending on Disease Status
24-36 Months depending on Disease Status

Sekundære resultatmål

Resultatmål
Tidsramme
Identify possible enhancements of the predictive and prognostic capabilities of the assay through the inclusion of molecular markers.
Tidsramme: 24-36 Months depending on Disease Status
24-36 Months depending on Disease Status

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Precision Therapeutics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2006

Studieafslutning (Faktiske)

1. oktober 2012

Datoer for studieregistrering

Først indsendt

25. april 2008

Først indsendt, der opfyldte QC-kriterier

28. april 2008

Først opslået (Skøn)

30. april 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PT-206 ChemoFx® PRO Study

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 .

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