ID

15935

Beschreibung

REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT; ODM derived from: https://clinicaltrials.gov/show/NCT01762592

Link

https://clinicaltrials.gov/show/NCT01762592

Stichworte

Versionen (1)
  1. 20.06.16 20.06.16 -
Hochgeladen am

20. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT01762592

Englisch

Eligibility Renal Cell Carcinoma NCT01762592

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ≥18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. presence of indeterminate ct1 renal mass by screening ct with and without contrast or mri with and without contrast (mri only if ct is contra-indicated).
Beschreibung

Renal mass Indeterminate | TNM clinical staging | X-Ray Computed Tomography | ct scan contrast | Magnetic Resonance Imaging | MRI with contrast | Medical contraindication X-Ray Computed Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C0205258
UMLS CUI [2]
C3258246
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0742919
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0202671
UMLS CUI [7,1]
C1301624
UMLS CUI [7,2]
C0040405
3. negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0013230
4. recovered from toxicity of any prior therapy to grade 1 or better.
Beschreibung

Prior Therapy | Toxic effect Recovered | National Cancer Institute common terminology criteria for adverse events

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0521108
UMLS CUI [3]
C1516728
5. able to take oral medication (ki).
Beschreibung

Able to swallow oral medication | Potassium Iodide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2]
C0032831
6. written informed consent available.
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. renal mass known to be a metastasis of another primary tumor.
Beschreibung

Renal mass | Neoplasm Metastasis | primary tumor Other

Datentyp

boolean

Alias
UMLS CUI [1]
C0262613
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0205394
2. known histology of renal mass (e.g. by biopsy).
Beschreibung

Renal mass Histology aspects | Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262613
UMLS CUI [1,2]
C4048239
UMLS CUI [2]
C0005558
3. active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
Beschreibung

Malignant Neoplasms Requirement Therapeutic procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0087111
4. chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to iodine (124i) girentuximab infusion on day 0 or continuing adverse effects (>grade 1) from such therapy.
Beschreibung

Chemotherapy Regimen | Therapeutic radiology procedure | Immunotherapy | iodine I-124 Girentuximab | Adverse effects Continuous

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C1708573
UMLS CUI [5,1]
C0879626
UMLS CUI [5,2]
C0549178
5. exposure to murine proteins or chimeric antibodies within the last 5 years.
Beschreibung

Exposure to murine protein | Exposure to chimeric antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C0598622
6. intercurrent medical condition that may limit patient's study participation or compliance.
Beschreibung

Intercurrent disease Study Subject Participation Status Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0439801
7. history of autoimmune hepatitis.
Beschreibung

Hepatitis, Autoimmune

Datentyp

boolean

Alias
UMLS CUI [1]
C0241910
8. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
Beschreibung

Mental impairment Informed Consent Limited | Mental impairment Compliance behavior Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683322
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C0683322
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
9. participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
10. women who are pregnant or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. contraindication to ki intake (see package insert/appendix vi).
Beschreibung

Medical contraindication Potassium Iodide

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0032831
12. hyperthyroidism, or grave's disease.
Beschreibung

Hyperthyroidism | Graves Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0020550
UMLS CUI [2]
C0018213
13. contraindication for pet/ct.
Beschreibung

Medical contraindication PET/CT scan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1699633
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Renal Cell Carcinoma NCT01762592

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. ≥18 years of age.
boolean
C0001779 (UMLS CUI [1])
Renal mass Indeterminate | TNM clinical staging | X-Ray Computed Tomography | ct scan contrast | Magnetic Resonance Imaging | MRI with contrast | Medical contraindication X-Ray Computed Tomography
Item
2. presence of indeterminate ct1 renal mass by screening ct with and without contrast or mri with and without contrast (mri only if ct is contra-indicated).
boolean
C0262613 (UMLS CUI [1,1])
C0205258 (UMLS CUI [1,2])
C3258246 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0742919 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0202671 (UMLS CUI [6])
C1301624 (UMLS CUI [7,1])
C0040405 (UMLS CUI [7,2])
Childbearing Potential Serum pregnancy test negative | Investigational New Drugs
Item
3. negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Prior Therapy | Toxic effect Recovered | National Cancer Institute common terminology criteria for adverse events
Item
4. recovered from toxicity of any prior therapy to grade 1 or better.
boolean
C1514463 (UMLS CUI [1])
C0600688 (UMLS CUI [2,1])
C0521108 (UMLS CUI [2,2])
C1516728 (UMLS CUI [3])
Able to swallow oral medication | Potassium Iodide
Item
5. able to take oral medication (ki).
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0032831 (UMLS CUI [2])
Informed consent
Item
6. written informed consent available.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Renal mass | Neoplasm Metastasis | primary tumor Other
Item
1. renal mass known to be a metastasis of another primary tumor.
boolean
C0262613 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0677930 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
Renal mass Histology aspects | Biopsy
Item
2. known histology of renal mass (e.g. by biopsy).
boolean
C0262613 (UMLS CUI [1,1])
C4048239 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
Malignant Neoplasms Requirement Therapeutic procedure
Item
3. active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
boolean
C0006826 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Chemotherapy Regimen | Therapeutic radiology procedure | Immunotherapy | iodine I-124 Girentuximab | Adverse effects Continuous
Item
4. chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to iodine (124i) girentuximab infusion on day 0 or continuing adverse effects (>grade 1) from such therapy.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1708573 (UMLS CUI [4])
C0879626 (UMLS CUI [5,1])
C0549178 (UMLS CUI [5,2])
Exposure to murine protein | Exposure to chimeric antibody
Item
5. exposure to murine proteins or chimeric antibodies within the last 5 years.
boolean
C0332157 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0598622 (UMLS CUI [2,2])
Intercurrent disease Study Subject Participation Status Limited
Item
6. intercurrent medical condition that may limit patient's study participation or compliance.
boolean
C0277557 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Hepatitis, Autoimmune
Item
7. history of autoimmune hepatitis.
boolean
C0241910 (UMLS CUI [1])
Mental impairment Informed Consent Limited | Mental impairment Compliance behavior Limited
Item
8. mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
boolean
C0683322 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0683322 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Study Subject Participation Status | Investigational New Drugs
Item
9. participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
10. women who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Medical contraindication Potassium Iodide
Item
11. contraindication to ki intake (see package insert/appendix vi).
boolean
C1301624 (UMLS CUI [1,1])
C0032831 (UMLS CUI [1,2])
Hyperthyroidism | Graves Disease
Item
12. hyperthyroidism, or grave's disease.
boolean
C0020550 (UMLS CUI [1])
C0018213 (UMLS CUI [2])
Medical contraindication PET/CT scan
Item
13. contraindication for pet/ct.
boolean
C1301624 (UMLS CUI [1,1])
C1699633 (UMLS CUI [1,2])
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