ID

36852

Beskrivning

PET/MR Assessment of Sipuleucel T Treatment for Metastatic Castration Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02042053

Länk

https://clinicaltrials.gov/show/NCT02042053

Nyckelord

Versioner (1)
  1. 2019-06-16 2019-06-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02042053

Engelsk

Eligibility Prostate Cancer NCT02042053

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
men ≥ 18 years of age
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
history of prostate cancer treated with androgen deprivation
Beskrivning

Antiandrogen therapy Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279492
UMLS CUI [1,2]
C0600139
serum testosterone levels <50 ng/ml
Beskrivning

Serum testosterone measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0428413
established asymptomatic or minimally symptomatic metastasis
Beskrivning

Neoplasm Metastasis Asymptomatic | Neoplasm Metastasis Minimal Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0231221
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0547040
UMLS CUI [2,3]
C0231220
eastern cooperative oncology group (ecog) performance status≤2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent
Beskrivning

Imaging Agreement | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079595
UMLS CUI [1,2]
C0680240
UMLS CUI [2]
C0525058
accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent
Beskrivning

Immune monitoring Agreement | Blood drawing Agreement | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0026428
UMLS CUI [1,2]
C0680240
UMLS CUI [2,1]
C0190979
UMLS CUI [2,2]
C0680240
UMLS CUI [3]
C0525058
patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with zytega or ketoconazole prior to enrollment are eligible
Beskrivning

Steroids | Prednisone U/day | Hydrocortisone U/day | Zytiga | Ketoconazole | Combined Modality Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0038317
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0020268
UMLS CUI [3,2]
C0456683
UMLS CUI [4]
C3153774
UMLS CUI [5]
C0022625
UMLS CUI [6]
C0009429
patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone <2 mg daily or fludrocortisone 0.1 mg daily orally)
Beskrivning

Steroids Chronic condition | Prednisone U/day | Dexamethasone U/day | Fludrocortisone Oral Product U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C4315615
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0011777
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C3214614
UMLS CUI [4,2]
C0456683
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy or radiation therapy treatment within 21 days of sipuleucel-t
Beskrivning

Chemotherapy | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
ecog performance status >2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
prior treatment with sipuleucel-t
Beskrivning

sipuleucel-T

Datatyp

boolean

Alias
UMLS CUI [1]
C1706668
patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin
Beskrivning

Cancer Other Primary | Curative treatment Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1273390
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
patients with known positivity for human immunodeficiency virus (hiv) or hepatitis c; baseline testing for hiv and hepatitis c is not required
Beskrivning

HIV Seropositivity | Hepatitis C positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
Beskrivning

Treatment Compliance Lacking | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
active spinal cord compression.
Beskrivning

Compression of spinal cord

Datatyp

boolean

Alias
UMLS CUI [1]
C0037926
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Similar models

Eligibility Prostate Cancer NCT02042053

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Antiandrogen therapy Prostate carcinoma
Item
history of prostate cancer treated with androgen deprivation
boolean
C0279492 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Serum testosterone measurement
Item
serum testosterone levels <50 ng/ml
boolean
C0428413 (UMLS CUI [1])
Neoplasm Metastasis Asymptomatic | Neoplasm Metastasis Minimal Symptomatic
Item
established asymptomatic or minimally symptomatic metastasis
boolean
C0027627 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status≤2
boolean
C1520224 (UMLS CUI [1])
Imaging Agreement | Protocol Compliance
Item
accept the terms of the imaging modalities and performance at pre-established time points as described in the protocol and consent
boolean
C0079595 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Immune monitoring Agreement | Blood drawing Agreement | Protocol Compliance
Item
accept the terms for immune-monitoring blood drawing and performance at pre-established time points as described in the protocol and consent
boolean
C0026428 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C0190979 (UMLS CUI [2,1])
C0680240 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Steroids | Prednisone U/day | Hydrocortisone U/day | Zytiga | Ketoconazole | Combined Modality Therapy
Item
patients that are on steroids (prednisone up to 10mg daily or hydrocortisone 20 mg daily) alone or in combination with zytega or ketoconazole prior to enrollment are eligible
boolean
C0038317 (UMLS CUI [1])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0020268 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C3153774 (UMLS CUI [4])
C0022625 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
Steroids Chronic condition | Prednisone U/day | Dexamethasone U/day | Fludrocortisone Oral Product U/day
Item
patients that are on steroids for an underlying chronic condition are eligible. (prednisone up to 10 mg daily, dexamethasone <2 mg daily or fludrocortisone 0.1 mg daily orally)
boolean
C0038317 (UMLS CUI [1,1])
C4315615 (UMLS CUI [1,2])
C0032952 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0011777 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C3214614 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure
Item
chemotherapy or radiation therapy treatment within 21 days of sipuleucel-t
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status >2
boolean
C1520224 (UMLS CUI [1])
sipuleucel-T
Item
prior treatment with sipuleucel-t
boolean
C1706668 (UMLS CUI [1])
Cancer Other Primary | Curative treatment Absent | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
patients with a history of another primary malignancy within the last 2 years that was not curatively treated, excluding basal or squamous cell carcinoma of the skin
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1273390 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
HIV Seropositivity | Hepatitis C positive
Item
patients with known positivity for human immunodeficiency virus (hiv) or hepatitis c; baseline testing for hiv and hepatitis c is not required
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
Treatment Compliance Lacking | Informed Consent Unable
Item
patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
boolean
C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Compression of spinal cord
Item
active spinal cord compression.
boolean
C0037926 (UMLS CUI [1])
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