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Demographics, Clinical Outcomes, and Physician Attitudes in Patients Who Have Received The MiCK Assay (CorrectChemo)

20. juli 2016 opdateret af: Pierian Biosciences

Chart Review of Demographics and Clinical Outcomes and Physician Attitudes in Patients Who Have Received the Microculture Kinetic (MiCK) Apoptosis Test

Recently an automated test for measuring cancer cell death in the presence of chemotherapy has been developed. This test has been called the MiCK assay during the ten year development phase and is now called Correct Chemo.

CorrectChemo provides the medical community and patients a way to determine the effects of different chemotherapies on individual cancer cells.

MiCK assay has been proven to have clinical usefulness in two studies. In one study using multiple types of cancer, physicians used the MiCK assay in 63% of the patients. If the physician used the results to prescribe the chemotherapy treatment, the patients' response rate, time to the disease getting worse, and overall survival were all significantly better compared to patients whose physicians did not use the results. In another study of breast cancer patients, physicians used the MiCK assay in 74% of patients. If the results were used when planning chemotherapy, response rate and time to the disease started getting worse were all significantly better compared to patients whose physicians did not use the results of the MiCK assay The purpose of this study is to compare the outcomes of patients who have had the MiCK assay (CorrectChemo) with tumor types, physician attitudes towards the test, and how the physicians used the test. This study will be gathering this data by reviewing medical charts.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to correlate the clinical outcomes of patients who have had the MICK assay with tumor type, physician attitudes towards the assay, and how physicians used the assay by using data in patient charts, and surveying physician attitudes.

Study Objectives:

  1. To determine how often physicians use the MiCK assay results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
  2. To determine physician attitudes towards the MiCK assay.
  3. To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay. This will be correlated with pattern of physician use of the assay.

Treatment Plan:

  1. The treating oncologist will provide demographic information (patient identifying number, sex, age, number of prior lines of therapy, performance status) and tumor information (cell type, stage, metastatic sites, goal of therapy, pre-assay planned therapy, and post-assay therapy chosen for
  2. Tumor response, patient symptom response, time to progression on each chemotherapy regimen, and overall survival will be determined from the patient chart and will be correlated with MICK assay results.
  3. Physicians will complete a questionnaire on attitudes towards usefulness of the assay.

Statistics

  1. Investigators will correlate tumor response, symptom response, time to progression and overall survival with drug therapy with drug response in MICK assay for first chemo regimen after assay, and according to pattern of physician use of the assay.
  2. We will accumulate physician attitudes toward usefulness of the assay.

Informed Consent Since this study has no risk to the patient, informed consent will not be needed. Physicians will have the option of participating, or not participating, in each patient. Physicians will be compensated for completing chart review and submitting data after the MiCK assay has been performed, and at 6,12 and 24 months after MiCK assay.

Data Collection from Physicians Data will include demographics and tumor characteristics and physician attitudes: I used the test to develop a treatment plan yes/no, I found the test useful yes/no, I found the test to be helpful in planning for palliative care yes/no, I found the test to be helpful in planning for hospice yes/no. I have these suggestions for improvement (free text response). Data will include at 6,12 and 24 months clinical outcomes as judged by the physician: Complete, Partial, Stable, Death, symptomatic improvement patient felt better same or worse. Data will include at time of progression, did doctor use the MiCK assay to plan the next treatment, try to get another MiCK assay, or use the assay to plan for palliative care or hospice.

Undersøgelsestype

Observationel

Kontakter og lokationer

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

Studiesteder

    • Quebec
      • Montreal, Quebec, Canada, H2X3P9
        • DiaTech Oncology
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37069
        • DiaTech Oncology

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) performed

Beskrivelse

Inclusion Criteria:

  • Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (Correct Chemo) performed

Exclusion Criteria:

  • Patients whose physician refuses to provide data.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients that received MICK assay
Patients with pathological diagnoses of cancer or leukemia who have had a MiCK assay (CorrectChemo) test performed
An automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells; the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells.
Andre navne:
  • CorrectChemo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical composite outcomes
Tidsramme: 6 months
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo.) This will be correlated with pattern of physician use of the assay.
6 months
Clinical composite outcomes
Tidsramme: 12 months
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo). This will be correlated with pattern of physician use of the assay.
12 months
Clinical composite outcomes
Tidsramme: 24 months
To determine the clinical outcomes (response rates, time to progression, and overall survival) in patients who have had a MiCK assay (CorrectChemo.) This will be correlated with pattern of physician use of the assay.
24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
Tidsramme: 6 months
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
6 months
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
Tidsramme: 12 months
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
12 months
How often Physicians use MiCK assay (CorrectChemo) results in patient treatment plan
Tidsramme: 24 months
To determine how often physicians use the MiCK assay (CorrectChemo) results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physician attitudes
Tidsramme: 6 months
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
6 months
Physician attitudes
Tidsramme: 12 months
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
12 months
Physician attitudes
Tidsramme: 24 months
To determine how often physicians use the MiCK assay (CorrectChemo)results in developing a treatment plan, and which drugs the physician used in treatment. This will be correlated with patient and tumor demographics.
24 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Allan Hallquist, MD, Pierian Biosciences

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. april 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

23. april 2014

Først indsendt, der opfyldte QC-kriterier

12. maj 2014

Først opslået (Skøn)

14. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1143088
  • 187128 (Andet bevillings-/finansieringsnummer: DiaTech)

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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