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ID

15805

Beskrivning

Treating Peritoneal Carcinomatosis With PIPAC; ODM derived from: https://clinicaltrials.gov/show/NCT02320448

Länk

https://clinicaltrials.gov/show/NCT02320448

Nyckelord

  1. 2016-06-14 2016-06-14 -
Uppladdad den

14 juni 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Peritoneal Carcinomatosis NCT02320448

    Eligibility Peritoneal Carcinomatosis NCT02320448

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    clinical and radiological evidence of peritoneal carcinomatosis.
    Beskrivning

    Carcinomatosis of peritoneal cavity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0346990
    no indication for standard chemotherapy which prolongs overall survival for at least three months.
    Beskrivning

    No indication of Chemotherapy | Survival time

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0521090
    UMLS CUI [1,2]
    C0392920
    UMLS CUI [2]
    C2919552
    performance status 0-2 and life expectancy of more than 3 months.
    Beskrivning

    performance status | Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1518965
    UMLS CUI [2]
    C0023671
    age > 18 years.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    written informed consent must be obtained according to the local ethics committee requirements.
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    extraabdominal metastatic disease.
    Beskrivning

    Metastatic Neoplasm Abdomen outside

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2939420
    UMLS CUI [1,2]
    C0000726
    UMLS CUI [1,3]
    C0205101
    symptomatic small bowel obstruction (total parenteral nutrition, nasogastric tube).
    Beskrivning

    Small bowel obstruction Symptomatic | Parenteral Nutrition, Total | Nasogastric tube

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0235329
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C0030548
    UMLS CUI [3]
    C0085678
    chemotherapy or surgery within the last four weeks prior to the first pipac application.
    Beskrivning

    Chemotherapy | Operative Surgical Procedures | Therapy, Investigational

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0543467
    UMLS CUI [3]
    C0949266
    previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
    Beskrivning

    Prior Therapy Cumulative Dose Maximum | Doxorubicin | Daunorubicin | Epirubicin | Idarubicin | Anthracyclines | Anthraquinones

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C2986497
    UMLS CUI [1,3]
    C0806909
    UMLS CUI [2]
    C0013089
    UMLS CUI [3]
    C0011015
    UMLS CUI [4]
    C0014582
    UMLS CUI [5]
    C0020789
    UMLS CUI [6]
    C0282564
    UMLS CUI [7]
    C0003174
    a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
    Beskrivning

    Allergic Reaction Cisplatin | Allergic Reaction Platinum-containing Compounds | Allergic Reaction Doxorubicin

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304
    UMLS CUI [1,2]
    C0008838
    UMLS CUI [2,1]
    C1527304
    UMLS CUI [2,2]
    C2266854
    UMLS CUI [3,1]
    C1527304
    UMLS CUI [3,2]
    C0013089
    renal impairment, defined as gfr < 60 ml/min.
    Beskrivning

    Renal Insufficiency | Glomerular Filtration Rate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0017654
    myocardial insufficiency, defined as nyha class > 2.
    Beskrivning

    myocardial; deficiency | New York Heart Association Classification

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1401079
    UMLS CUI [2]
    C1275491
    impaired liver function defined as bilirubin ≥ 1,5 x unl (upper normal limit).
    Beskrivning

    Liver Dysfunction | Serum total bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0086565
    UMLS CUI [2]
    C1278039
    inadequate haematological function defined as anc ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
    Beskrivning

    Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221130
    UMLS CUI [1,2]
    C0205412
    UMLS CUI [2]
    C0948762
    UMLS CUI [3]
    C0032181
    any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
    Beskrivning

    Condition At risk Patient | Therapeutic procedure At risk Patient | Condition Interferes with Study Protocol | Therapeutic procedure Interferes with Study Protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C0030705
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C1444641
    UMLS CUI [2,3]
    C0030705
    UMLS CUI [3,1]
    C0348080
    UMLS CUI [3,2]
    C0521102
    UMLS CUI [3,3]
    C2348563
    UMLS CUI [4,1]
    C0087111
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C2348563
    previous intraabdominal chemotherapy or intraabdominal antibody therapy.
    Beskrivning

    Prior Chemotherapy intraabdominal | antibody therapy intraabdominal Previous

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0230168
    UMLS CUI [2,1]
    C0281176
    UMLS CUI [2,2]
    C0230168
    UMLS CUI [2,3]
    C0205156

    Similar models

    Eligibility Peritoneal Carcinomatosis NCT02320448

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Carcinomatosis of peritoneal cavity
    Item
    clinical and radiological evidence of peritoneal carcinomatosis.
    boolean
    C0346990 (UMLS CUI [1])
    No indication of Chemotherapy | Survival time
    Item
    no indication for standard chemotherapy which prolongs overall survival for at least three months.
    boolean
    C0521090 (UMLS CUI [1,1])
    C0392920 (UMLS CUI [1,2])
    C2919552 (UMLS CUI [2])
    performance status | Life Expectancy
    Item
    performance status 0-2 and life expectancy of more than 3 months.
    boolean
    C1518965 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    Age
    Item
    age > 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Informed consent
    Item
    written informed consent must be obtained according to the local ethics committee requirements.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Metastatic Neoplasm Abdomen outside
    Item
    extraabdominal metastatic disease.
    boolean
    C2939420 (UMLS CUI [1,1])
    C0000726 (UMLS CUI [1,2])
    C0205101 (UMLS CUI [1,3])
    Small bowel obstruction Symptomatic | Parenteral Nutrition, Total | Nasogastric tube
    Item
    symptomatic small bowel obstruction (total parenteral nutrition, nasogastric tube).
    boolean
    C0235329 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0030548 (UMLS CUI [2])
    C0085678 (UMLS CUI [3])
    Chemotherapy | Operative Surgical Procedures | Therapy, Investigational
    Item
    chemotherapy or surgery within the last four weeks prior to the first pipac application.
    boolean
    C0392920 (UMLS CUI [1])
    C0543467 (UMLS CUI [2])
    C0949266 (UMLS CUI [3])
    Prior Therapy Cumulative Dose Maximum | Doxorubicin | Daunorubicin | Epirubicin | Idarubicin | Anthracyclines | Anthraquinones
    Item
    previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
    boolean
    C1514463 (UMLS CUI [1,1])
    C2986497 (UMLS CUI [1,2])
    C0806909 (UMLS CUI [1,3])
    C0013089 (UMLS CUI [2])
    C0011015 (UMLS CUI [3])
    C0014582 (UMLS CUI [4])
    C0020789 (UMLS CUI [5])
    C0282564 (UMLS CUI [6])
    C0003174 (UMLS CUI [7])
    Allergic Reaction Cisplatin | Allergic Reaction Platinum-containing Compounds | Allergic Reaction Doxorubicin
    Item
    a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
    boolean
    C1527304 (UMLS CUI [1,1])
    C0008838 (UMLS CUI [1,2])
    C1527304 (UMLS CUI [2,1])
    C2266854 (UMLS CUI [2,2])
    C1527304 (UMLS CUI [3,1])
    C0013089 (UMLS CUI [3,2])
    Renal Insufficiency | Glomerular Filtration Rate
    Item
    renal impairment, defined as gfr < 60 ml/min.
    boolean
    C1565489 (UMLS CUI [1])
    C0017654 (UMLS CUI [2])
    myocardial; deficiency | New York Heart Association Classification
    Item
    myocardial insufficiency, defined as nyha class > 2.
    boolean
    C1401079 (UMLS CUI [1])
    C1275491 (UMLS CUI [2])
    Liver Dysfunction | Serum total bilirubin measurement
    Item
    impaired liver function defined as bilirubin ≥ 1,5 x unl (upper normal limit).
    boolean
    C0086565 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement
    Item
    inadequate haematological function defined as anc ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
    boolean
    C0221130 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0948762 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Condition At risk Patient | Therapeutic procedure At risk Patient | Condition Interferes with Study Protocol | Therapeutic procedure Interferes with Study Protocol
    Item
    any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
    boolean
    C0348080 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C0030705 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [2,1])
    C1444641 (UMLS CUI [2,2])
    C0030705 (UMLS CUI [2,3])
    C0348080 (UMLS CUI [3,1])
    C0521102 (UMLS CUI [3,2])
    C2348563 (UMLS CUI [3,3])
    C0087111 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C2348563 (UMLS CUI [4,3])
    Prior Chemotherapy intraabdominal | antibody therapy intraabdominal Previous
    Item
    previous intraabdominal chemotherapy or intraabdominal antibody therapy.
    boolean
    C1514457 (UMLS CUI [1,1])
    C0230168 (UMLS CUI [1,2])
    C0281176 (UMLS CUI [2,1])
    C0230168 (UMLS CUI [2,2])
    C0205156 (UMLS CUI [2,3])

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