0 Bewertungen
ID

41010

Beschreibung

Preoperative Treatment With Cetuximab and/or IMC-A12; ODM derived from: https://clinicaltrials.gov/show/NCT00957853

Link

https://clinicaltrials.gov/show/NCT00957853

Stichworte

Versionen (1)
  1. 11.06.20 11.06.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. Juni 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

  • Neueste
  • Älteste
  • Beliebt
  • Neueste
    • Neueste
    • Älteste
    • Beliebt

    Keine Kommentare

    Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

    Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

    Englisch

    Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types ii and iii according to the world health organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
    Beschreibung

    Squamous cell carcinoma of the head and neck | Exception Nasopharyngeal carcinoma Type | Excision of neoplasm Planned | Cutaneous Squamous Cell Carcinoma of the Head and Neck

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1168401 (Squamous cell carcinoma of the head and neck)
    SNOMED
    716659002
    UMLS CUI [2,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [2,2]
    C2931822 (Nasopharyngeal carcinoma)
    SNOMED
    449248000
    UMLS CUI [2,3]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    UMLS CUI [3,1]
    C1299802 (Excision of neoplasm)
    SNOMED
    370612006
    UMLS CUI [3,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    UMLS CUI [4]
    C4524517 (Cutaneous Squamous Cell Carcinoma of the Head and Neck)
    2. there is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. no anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. if a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
    Beschreibung

    Availability of Tumor tissue sample Paraffin Embedded | Biomarker Evaluation | Antineoplastic Therapy Absent | Tumor tissue sample Unavailable | Tumor Biopsy

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187 (Availability of)
    SNOMED
    103328004
    UMLS CUI [1,2]
    C0475358 (Tumor tissue sample)
    SNOMED
    258435002
    UMLS CUI [1,3]
    C0085185 (Paraffin Embedding)
    SNOMED
    702941008
    UMLS CUI [2,1]
    C0005516 (Biological Markers)
    UMLS CUI [2,2]
    C1261322 (Evaluation procedure)
    SNOMED
    129265001
    LOINC
    LA15395-9
    UMLS CUI [3,1]
    C2346834 (Antineoplastic Drug/Agent Therapy)
    UMLS CUI [3,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    UMLS CUI [4,1]
    C0475358 (Tumor tissue sample)
    SNOMED
    258435002
    UMLS CUI [4,2]
    C0686905 (Unavailability)
    SNOMED
    103329007
    LOINC
    LA7287-1
    UMLS CUI [5,1]
    C0027651 (Neoplasms)
    SNOMED
    108369006
    UMLS CUI [5,2]
    C0005558 (Biopsy)
    SNOMED
    129314006
    LOINC
    LP68311-7
    3. prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
    Beschreibung

    Biological agents Targeted Therapy Epidermal Growth Factor Receptor

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005515 (Biological Factors)
    SNOMED
    115668003
    UMLS CUI [1,2]
    C2985566 (Targeted Therapy)
    UMLS CUI [1,3]
    C0034802 (Epidermal Growth Factor Receptor)
    SNOMED
    86960007
    4. the patient has a fasting serum glucose < 130 mg/dl and hba1c < 7.0%. patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
    Beschreibung

    Serum fasting glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus Diet therapy Stable | Diabetes Mellitus Therapy Stable

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0583334 (Serum fasting glucose measurement)
    SNOMED
    167087006
    UMLS CUI [2]
    C0474680 (Hemoglobin A1c measurement)
    SNOMED
    43396009
    UMLS CUI [3,1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [3,2]
    C0012159 (Diet therapy)
    UMLS CUI [3,3]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    UMLS CUI [4,1]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [4,2]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [4,3]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    5. the patient has adequate renal function, defined by serum creatinine </= 1.5 * the institutional upper limit of normal (uln), or creatinine clearance >/=60 ml/min for patients with creatinine levels above the uln.
    Beschreibung

    Renal function | Creatinine measurement, serum

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [2]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    6. because the teratogenicity of cetuximab and imc-a12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
    Beschreibung

    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118 (Childbearing Potential)
    UMLS CUI [1,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2,1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    UMLS CUI [2,2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [3]
    C2985296 (Hormonal Contraception)
    UMLS CUI [4]
    C0004764 (Contraception, Barrier)
    SNOMED
    225370004
    UMLS CUI [5]
    C0036899 (Sexual Abstinence)
    7. the patient is age >/= 18 years.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    8. the patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
    Beschreibung

    Informed Consent | Informed Consent Patient Representative

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    UMLS CUI [2,1]
    C0021430 (Informed Consent)
    UMLS CUI [2,2]
    C0030701 (Patient Representatives)
    9. eastern cooperative oncology group (ecog) performance status of 0-2.
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
    Beschreibung

    Antineoplastic Agents

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003392 (Antineoplastic Agents)
    SNOMED
    27867009
    2. patients receiving concomitant radiation.
    Beschreibung

    Therapeutic radiology procedure

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    3. prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
    Beschreibung

    Targeted Therapy Insulin-Like-Growth Factor I Receptor

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2985566 (Targeted Therapy)
    UMLS CUI [1,2]
    C0140080 (Insulin-Like-Growth Factor I Receptor)
    4. history of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or imc-a12.
    Beschreibung

    Allergic Reaction Compound Cetuximab Similar | Allergic Reaction Compound IMC-A12 Similar

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [1,2]
    C1706082 (Compound (substance))
    UMLS CUI [1,3]
    C0995188 (cetuximab)
    SNOMED
    409401002
    UMLS CUI [1,4]
    C2348205 (Similarity)
    UMLS CUI [2,1]
    C1527304 (Allergic Reaction)
    SNOMED
    419076005
    UMLS CUI [2,2]
    C1706082 (Compound (substance))
    UMLS CUI [2,3]
    C3180625 (IMC-A12)
    UMLS CUI [2,4]
    C2348205 (Similarity)
    5. pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
    Beschreibung

    Pregnancy | Breast Feeding

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    6. patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
    Beschreibung

    Illness Uncontrolled | Exacerbation Possible Due to Investigational New Drugs

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0205318 (Uncontrolled)
    SNOMED
    19032002
    UMLS CUI [2,1]
    C4086268 (Exacerbation)
    UMLS CUI [2,2]
    C0332149 (Possible)
    SNOMED
    371930009
    LOINC
    LA15097-1
    UMLS CUI [2,3]
    C0678226 (Due to)
    SNOMED
    42752001
    UMLS CUI [2,4]
    C0013230 (Investigational New Drugs)
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Squamous cell carcinoma of the head and neck | Exception Nasopharyngeal carcinoma Type | Excision of neoplasm Planned | Cutaneous Squamous Cell Carcinoma of the Head and Neck
    Item
    1. histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types ii and iii according to the world health organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
    boolean
    C1168401 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C2931822 (UMLS CUI [2,2])
    C0332307 (UMLS CUI [2,3])
    C1299802 (UMLS CUI [3,1])
    C1301732 (UMLS CUI [3,2])
    C4524517 (UMLS CUI [4])
    Availability of Tumor tissue sample Paraffin Embedded | Biomarker Evaluation | Antineoplastic Therapy Absent | Tumor tissue sample Unavailable | Tumor Biopsy
    Item
    2. there is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. no anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. if a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
    boolean
    C0470187 (UMLS CUI [1,1])
    C0475358 (UMLS CUI [1,2])
    C0085185 (UMLS CUI [1,3])
    C0005516 (UMLS CUI [2,1])
    C1261322 (UMLS CUI [2,2])
    C2346834 (UMLS CUI [3,1])
    C0332197 (UMLS CUI [3,2])
    C0475358 (UMLS CUI [4,1])
    C0686905 (UMLS CUI [4,2])
    C0027651 (UMLS CUI [5,1])
    C0005558 (UMLS CUI [5,2])
    Biological agents Targeted Therapy Epidermal Growth Factor Receptor
    Item
    3. prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
    boolean
    C0005515 (UMLS CUI [1,1])
    C2985566 (UMLS CUI [1,2])
    C0034802 (UMLS CUI [1,3])
    Serum fasting glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus Diet therapy Stable | Diabetes Mellitus Therapy Stable
    Item
    4. the patient has a fasting serum glucose < 130 mg/dl and hba1c < 7.0%. patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
    boolean
    C0583334 (UMLS CUI [1])
    C0474680 (UMLS CUI [2])
    C0011849 (UMLS CUI [3,1])
    C0012159 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    C0011849 (UMLS CUI [4,1])
    C0087111 (UMLS CUI [4,2])
    C0205360 (UMLS CUI [4,3])
    Renal function | Creatinine measurement, serum
    Item
    5. the patient has adequate renal function, defined by serum creatinine </= 1.5 * the institutional upper limit of normal (uln), or creatinine clearance >/=60 ml/min for patients with creatinine levels above the uln.
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
    Item
    6. because the teratogenicity of cetuximab and imc-a12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0079399 (UMLS CUI [2,1])
    C0700589 (UMLS CUI [2,2])
    C2985296 (UMLS CUI [3])
    C0004764 (UMLS CUI [4])
    C0036899 (UMLS CUI [5])
    Age
    Item
    7. the patient is age >/= 18 years.
    boolean
    C0001779 (UMLS CUI [1])
    Informed Consent | Informed Consent Patient Representative
    Item
    8. the patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    ECOG performance status
    Item
    9. eastern cooperative oncology group (ecog) performance status of 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Antineoplastic Agents
    Item
    1. patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
    boolean
    C0003392 (UMLS CUI [1])
    Therapeutic radiology procedure
    Item
    2. patients receiving concomitant radiation.
    boolean
    C1522449 (UMLS CUI [1])
    Targeted Therapy Insulin-Like-Growth Factor I Receptor
    Item
    3. prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
    boolean
    C2985566 (UMLS CUI [1,1])
    C0140080 (UMLS CUI [1,2])
    Allergic Reaction Compound Cetuximab Similar | Allergic Reaction Compound IMC-A12 Similar
    Item
    4. history of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or imc-a12.
    boolean
    C1527304 (UMLS CUI [1,1])
    C1706082 (UMLS CUI [1,2])
    C0995188 (UMLS CUI [1,3])
    C2348205 (UMLS CUI [1,4])
    C1527304 (UMLS CUI [2,1])
    C1706082 (UMLS CUI [2,2])
    C3180625 (UMLS CUI [2,3])
    C2348205 (UMLS CUI [2,4])
    Pregnancy | Breast Feeding
    Item
    5. pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Illness Uncontrolled | Exacerbation Possible Due to Investigational New Drugs
    Item
    6. patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C4086268 (UMLS CUI [2,1])
    C0332149 (UMLS CUI [2,2])
    C0678226 (UMLS CUI [2,3])
    C0013230 (UMLS CUI [2,4])
    Zum Seitenanfang zurückkehren 

    Hilfe

    Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

    Zum Video