ID

36850

Descripción

Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02036918

Link

https://clinicaltrials.gov/show/NCT02036918

Palabras clave

Versiones (1)
  1. 16/6/19 16/6/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de junio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02036918

Inglés

Eligibility Prostate Cancer NCT02036918

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥ 18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. ecog performance status 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
3. life expectancy of ≥ 6 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
4. minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
Descripción

Hormone refractory prostate cancer metastatic minimal symptomatic | Hormone refractory prostate cancer metastatic asymptomatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1328504
UMLS CUI [1,2]
C1522484
UMLS CUI [1,3]
C0547040
UMLS CUI [1,4]
C0231220
UMLS CUI [2,1]
C1328504
UMLS CUI [2,2]
C1522484
UMLS CUI [2,3]
C0231221
1. histologically-confirmed diagnosis of adenocarcinoma of the prostate
Descripción

Adenocarcinoma of prostate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007112
2. evidence of adequate androgen deprivation, as evidence by one of the following:
Descripción

Androgen suppression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1515985
bilateral orchiectomy
Descripción

Male Castration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007347
ongoing lhrh agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
Descripción

Luteinizing Hormone-releasing Hormone Agonist | Leuprolide | Goserelin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2]
C0085272
UMLS CUI [3]
C0120107
ongoing lhrh antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
Descripción

Luteinizing hormone releasing hormone antagonist product | degarelix | Serum testosterone measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1276926
UMLS CUI [2]
C1455035
UMLS CUI [3]
C0428413
3. evidence of prostate cancer resistance to castration, as evidenced by one of the following:
Descripción

Hormone refractory prostate cancer

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1328504
2 consecutive psa levels that are ≥ 50% above the psa nadir achieved on adt and obtained at least 1 week apart
Descripción

Raised prostate specific antigen | PSA Level Nadir Antiandrogen therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0178415
UMLS CUI [2,1]
C4086720
UMLS CUI [2,2]
C1708760
UMLS CUI [2,3]
C0279492
ct or mri based evidence of disease progression (soft tissue or nodal) according to pcwg2 criteria or recist 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
Descripción

Disease Progression Soft tissue CT | Disease Progression Soft tissue MRI | Disease Progression Lymph nodes CT | Disease Progression Lymph nodes MRI | Lesion New Quantity Bone scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0225317
UMLS CUI [1,3]
C0040405
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0225317
UMLS CUI [2,3]
C0024485
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0024204
UMLS CUI [3,3]
C0040405
UMLS CUI [4,1]
C0242656
UMLS CUI [4,2]
C0024204
UMLS CUI [4,3]
C0024485
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0205314
UMLS CUI [5,3]
C1265611
UMLS CUI [5,4]
C0203668
4. presence of non-visceral metastases on imaging
Descripción

Neoplasm Metastasis Non-Visceral Imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1518392
UMLS CUI [1,3]
C0011923
5. absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
Descripción

Absence Symptoms Prostate carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0600139
ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
Descripción

Exception | Ureteral obstruction Secondary to Pelvic lymphadenopathy | Ureteral obstruction Secondary to Retroperitoneal lymphadenopathy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0041956
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C1264124
UMLS CUI [3,1]
C0041956
UMLS CUI [3,2]
C0175668
UMLS CUI [3,3]
C0748390
bladder outlet obstruction secondary to locally recurrent prostate cancer
Descripción

Exception | Bladder neck obstruction Secondary to Prostate cancer recurrent Locally

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1705847
UMLS CUI [2,1]
C0005694
UMLS CUI [2,2]
C0175668
UMLS CUI [2,3]
C0278838
UMLS CUI [2,4]
C1517927
5. radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (ct or mri or pet/ct)
Descripción

Lymphadenopathy Radiography | Lymph node Diameter CT | Lymph node Diameter MRI | Lymph node Diameter PET/CT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0034571
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C0024204
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0024485
UMLS CUI [4,1]
C0024204
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C1699633
6. adequate laboratory parameters
Descripción

Laboratory Parameters

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0449381
7. a minimum of 4 weeks from any major surgery prior to registration. coincident standard of care surgery with the research biopsy is permitted during the study.
Descripción

Major surgery Previous | Standard of Care Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2936643
UMLS CUI [2,2]
C0543467
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior treatment with sipuleucel-t
Descripción

sipuleucel-T

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1706668
2. allergy to any component of sipuleucel-t
Descripción

Hypersensitivity Sipuleucel-T Component

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1706668
UMLS CUI [1,3]
C1705248
3. inability to undergo leukapheresis
Descripción

Leukapheresis Receive Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
4. history of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
Descripción

Prostate Neuroendocrine Neoplasm | Small cell carcinoma of prostate

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1335515
UMLS CUI [2]
C1300585
5. extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
Descripción

Extensive surgical procedure Biopsy Complex | Prior Extensive Radiation Biopsy Complex | Extensive surgical procedure High risk of Intraoperative injury | Prior Extensive Radiation High risk of Intraoperative injury

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4060998
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0439855
UMLS CUI [2,1]
C1514458
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0439855
UMLS CUI [3,1]
C4060998
UMLS CUI [3,2]
C0332167
UMLS CUI [3,3]
C1558210
UMLS CUI [4,1]
C1514458
UMLS CUI [4,2]
C0332167
UMLS CUI [4,3]
C1558210
6. any chronic medical condition requiring daily corticosteroids or other immunosuppressants
Descripción

Chronic disease Requirement Adrenal Cortex Hormones Daily | Chronic disease Requirement Immunosuppressive Agents Daily

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0001617
UMLS CUI [1,4]
C0332173
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0021081
UMLS CUI [2,4]
C0332173
7. solid organ transplantation requiring immunosuppression
Descripción

Solid organ transplant Requirement Therapeutic immunosuppression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0730400
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
8. visceral (e.g. lung, liver) metastases
Descripción

Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0442045
UMLS CUI [2]
C0153676
UMLS CUI [3]
C0494165
9. known brain metastases
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
10. history of spinal cord compression
Descripción

Compression of spinal cord

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0037926
11. untreated/unstabilized pathologic long bone fractures
Descripción

Fractures of the long bones Untreated | Stabilization Lacking Fractures of the long bones

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0240231
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1293130
UMLS CUI [2,2]
C0332268
UMLS CUI [2,3]
C0240231
12. other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
Descripción

Cancer Other | Exception Skin carcinoma | Probability Percentage Recurrence

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C0033204
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0034897
13. administration of any investigational therapeutic within 30 days of registration
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
14. any condition which, in the opinion of the investigator, would preclude participation in this trial
Descripción

Condition Study Subject Participation Status Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
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Similar models

Eligibility Prostate Cancer NCT02036918

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
3. life expectancy of ≥ 6 months
boolean
C0023671 (UMLS CUI [1])
Hormone refractory prostate cancer metastatic minimal symptomatic | Hormone refractory prostate cancer metastatic asymptomatic
Item
4. minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:
boolean
C1328504 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
C0547040 (UMLS CUI [1,3])
C0231220 (UMLS CUI [1,4])
C1328504 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
Adenocarcinoma of prostate
Item
1. histologically-confirmed diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Androgen suppression
Item
2. evidence of adequate androgen deprivation, as evidence by one of the following:
boolean
C1515985 (UMLS CUI [1])
Male Castration
Item
bilateral orchiectomy
boolean
C0007347 (UMLS CUI [1])
Luteinizing Hormone-releasing Hormone Agonist | Leuprolide | Goserelin
Item
ongoing lhrh agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
boolean
C1518041 (UMLS CUI [1])
C0085272 (UMLS CUI [2])
C0120107 (UMLS CUI [3])
Luteinizing hormone releasing hormone antagonist product | degarelix | Serum testosterone measurement
Item
ongoing lhrh antagonist (e.g. degarelix) and serum testosterone <50 ng/dl
boolean
C1276926 (UMLS CUI [1])
C1455035 (UMLS CUI [2])
C0428413 (UMLS CUI [3])
Hormone refractory prostate cancer
Item
3. evidence of prostate cancer resistance to castration, as evidenced by one of the following:
boolean
C1328504 (UMLS CUI [1])
Raised prostate specific antigen | PSA Level Nadir Antiandrogen therapy
Item
2 consecutive psa levels that are ≥ 50% above the psa nadir achieved on adt and obtained at least 1 week apart
boolean
C0178415 (UMLS CUI [1])
C4086720 (UMLS CUI [2,1])
C1708760 (UMLS CUI [2,2])
C0279492 (UMLS CUI [2,3])
Disease Progression Soft tissue CT | Disease Progression Soft tissue MRI | Disease Progression Lymph nodes CT | Disease Progression Lymph nodes MRI | Lesion New Quantity Bone scan
Item
ct or mri based evidence of disease progression (soft tissue or nodal) according to pcwg2 criteria or recist 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
boolean
C0242656 (UMLS CUI [1,1])
C0225317 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0225317 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
C0242656 (UMLS CUI [3,1])
C0024204 (UMLS CUI [3,2])
C0040405 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4,1])
C0024204 (UMLS CUI [4,2])
C0024485 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C0205314 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
C0203668 (UMLS CUI [5,4])
Neoplasm Metastasis Non-Visceral Imaging
Item
4. presence of non-visceral metastases on imaging
boolean
C0027627 (UMLS CUI [1,1])
C1518392 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Absence Symptoms Prostate carcinoma
Item
5. absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:
boolean
C0332197 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Exception | Ureteral obstruction Secondary to Pelvic lymphadenopathy | Ureteral obstruction Secondary to Retroperitoneal lymphadenopathy
Item
ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
boolean
C1705847 (UMLS CUI [1])
C0041956 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C1264124 (UMLS CUI [2,3])
C0041956 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0748390 (UMLS CUI [3,3])
Exception | Bladder neck obstruction Secondary to Prostate cancer recurrent Locally
Item
bladder outlet obstruction secondary to locally recurrent prostate cancer
boolean
C1705847 (UMLS CUI [1])
C0005694 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0278838 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
Lymphadenopathy Radiography | Lymph node Diameter CT | Lymph node Diameter MRI | Lymph node Diameter PET/CT
Item
5. radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (ct or mri or pet/ct)
boolean
C0497156 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C0024204 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0024485 (UMLS CUI [3,3])
C0024204 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C1699633 (UMLS CUI [4,3])
Laboratory Parameters
Item
6. adequate laboratory parameters
boolean
C0022877 (UMLS CUI [1,1])
C0449381 (UMLS CUI [1,2])
Major surgery Previous | Standard of Care Operative Surgical Procedures
Item
7. a minimum of 4 weeks from any major surgery prior to registration. coincident standard of care surgery with the research biopsy is permitted during the study.
boolean
C0679637 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2936643 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
sipuleucel-T
Item
1. prior treatment with sipuleucel-t
boolean
C1706668 (UMLS CUI [1])
Hypersensitivity Sipuleucel-T Component
Item
2. allergy to any component of sipuleucel-t
boolean
C0020517 (UMLS CUI [1,1])
C1706668 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Leukapheresis Receive Unable
Item
3. inability to undergo leukapheresis
boolean
C0023416 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Prostate Neuroendocrine Neoplasm | Small cell carcinoma of prostate
Item
4. history of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
boolean
C1335515 (UMLS CUI [1])
C1300585 (UMLS CUI [2])
Extensive surgical procedure Biopsy Complex | Prior Extensive Radiation Biopsy Complex | Extensive surgical procedure High risk of Intraoperative injury | Prior Extensive Radiation High risk of Intraoperative injury
Item
5. extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
boolean
C4060998 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C1514458 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0439855 (UMLS CUI [2,3])
C4060998 (UMLS CUI [3,1])
C0332167 (UMLS CUI [3,2])
C1558210 (UMLS CUI [3,3])
C1514458 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
C1558210 (UMLS CUI [4,3])
Chronic disease Requirement Adrenal Cortex Hormones Daily | Chronic disease Requirement Immunosuppressive Agents Daily
Item
6. any chronic medical condition requiring daily corticosteroids or other immunosuppressants
boolean
C0008679 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0001617 (UMLS CUI [1,3])
C0332173 (UMLS CUI [1,4])
C0008679 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0021081 (UMLS CUI [2,3])
C0332173 (UMLS CUI [2,4])
Solid organ transplant Requirement Therapeutic immunosuppression
Item
7. solid organ transplantation requiring immunosuppression
boolean
C0730400 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Neoplasm Metastasis Visceral | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver
Item
8. visceral (e.g. lung, liver) metastases
boolean
C0027627 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
9. known brain metastases
boolean
C0220650 (UMLS CUI [1])
Compression of spinal cord
Item
10. history of spinal cord compression
boolean
C0037926 (UMLS CUI [1])
Fractures of the long bones Untreated | Stabilization Lacking Fractures of the long bones
Item
11. untreated/unstabilized pathologic long bone fractures
boolean
C0240231 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1293130 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
C0240231 (UMLS CUI [2,3])
Cancer Other | Exception Skin carcinoma | Probability Percentage Recurrence
Item
12. other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C0033204 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
Investigational New Drugs
Item
13. administration of any investigational therapeutic within 30 days of registration
boolean
C0013230 (UMLS CUI [1])
Condition Study Subject Participation Status Excluded
Item
14. any condition which, in the opinion of the investigator, would preclude participation in this trial
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
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