ID

15935

Description

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

Keywords

Versions (1)
  1. 6/20/16 6/20/16 -
Uploaded on

June 20, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Renal Cell Carcinoma NCT01762592

English

Eligibility Renal Cell Carcinoma NCT01762592

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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).
Description

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

Data type

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.
Description

Childbearing Potential Serum pregnancy test negative | Investigational New Drugs

Data type

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.
Description

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

Data type

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).
Description

Able to swallow oral medication | Potassium Iodide

Data type

boolean

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

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

Renal mass | Neoplasm Metastasis | primary tumor Other

Data type

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).
Description

Renal mass Histology aspects | Biopsy

Data type

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.
Description

Malignant Neoplasms Requirement Therapeutic procedure

Data type

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.
Description

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

Data type

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.
Description

Exposure to murine protein | Exposure to chimeric antibody

Data type

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.
Description

Intercurrent disease Study Subject Participation Status Limited

Data type

boolean

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

Hepatitis, Autoimmune

Data type

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.
Description

Mental impairment Informed Consent Limited | Mental impairment Compliance behavior Limited

Data type

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.
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Medical contraindication Potassium Iodide

Data type

boolean

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

Hyperthyroidism | Graves Disease

Data type

boolean

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

Medical contraindication PET/CT scan

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1699633
Back to the top of the page

Similar models

Eligibility Renal Cell Carcinoma NCT01762592

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial