ID

15935

Beschrijving

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

Trefwoorden

Versies (1)
  1. 20-06-16 20-06-16 -
Geüploaded op

20 juni 2016

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Renal Cell Carcinoma NCT01762592

Engels

Eligibility Renal Cell Carcinoma NCT01762592

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

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).
Beschrijving

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

Datatype

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.
Beschrijving

Childbearing Potential Serum pregnancy test negative | Investigational New Drugs

Datatype

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.
Beschrijving

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

Datatype

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).
Beschrijving

Able to swallow oral medication | Potassium Iodide

Datatype

boolean

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

Informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Renal mass | Neoplasm Metastasis | primary tumor Other

Datatype

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).
Beschrijving

Renal mass Histology aspects | Biopsy

Datatype

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.
Beschrijving

Malignant Neoplasms Requirement Therapeutic procedure

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Exposure to murine protein | Exposure to chimeric antibody

Datatype

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.
Beschrijving

Intercurrent disease Study Subject Participation Status Limited

Datatype

boolean

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

Hepatitis, Autoimmune

Datatype

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.
Beschrijving

Mental impairment Informed Consent Limited | Mental impairment Compliance behavior Limited

Datatype

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.
Beschrijving

Study Subject Participation Status | Investigational New Drugs

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Medical contraindication Potassium Iodide

Datatype

boolean

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

Hyperthyroidism | Graves Disease

Datatype

boolean

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

Medical contraindication PET/CT scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1699633
Terug naar het begin van de pagina

Similar models

Eligibility Renal Cell Carcinoma NCT01762592

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

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