ID

19043

Beschreibung

Zometa on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Ablation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT00582556

Link

https://clinicaltrials.gov/show/NCT00582556

Stichworte

Versionen (1)
  1. 01.12.16 01.12.16 -
Hochgeladen am

1. Dezember 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00582556

Englisch

Eligibility Prostate Cancer NCT00582556

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have a histologic diagnosis of adenocarcinoma of the prostate.
Beschreibung

Adenocarcinoma of prostate

Datentyp

boolean

Alias
UMLS CUI [1]
C0007112
for patients without clinical metastasis treated by surgery, serum psa values must be > 0.2 ng/ml by two measurements at least two weeks apart. in patients treated with ablative radiation therapy without clinical metastasis, three consecutive increases in serum psa must be documented, with at least a one-month interval between values with the final psa > 2ng/m as evidence of biochemical psa failure. p
Beschreibung

Neoplasm Metastasis | Operative Surgical Procedures | Prostate specific antigen measurement Quantity | Therapeutic radiology procedure Ablation | Serum Prostate Specific Antigen Increased Quantity | PSA Failure Evidence of

Datentyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C0201544
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0547070
UMLS CUI [5,1]
C1883014
UMLS CUI [5,2]
C1265611
UMLS CUI [6,1]
C2985506
UMLS CUI [6,2]
C0332120
patients who have not had prior primary therapy such as radiation or surgery, are required to have a detectable psa of at least 0.2 ng/ml.
Beschreibung

First line treatment | Therapeutic radiology procedure | Operative Surgical Procedures | Prostate specific antigen measurement | Prostate-Specific Antigen Detectable

Datentyp

boolean

Alias
UMLS CUI [1]
C1708063
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0543467
UMLS CUI [4]
C0201544
UMLS CUI [5,1]
C0138741
UMLS CUI [5,2]
C3830527
patients with evidence of metastatic disease are eligible irrespective of serum psa level.
Beschreibung

Neoplasm Metastasis Evidence of | Prostate specific antigen measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0201544
prior history of a second malignancy is allowed if treated with curative intent and patient has been free of disease greater than five years
Beschreibung

Malignant Neoplasm second Curative treatment | Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205436
UMLS CUI [1,3]
C1273390
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
ecog performance status of < 2.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with a gnrh analogue or anti-androgen.
Beschreibung

GnRH analog | Androgen Antagonists

Datentyp

boolean

Alias
UMLS CUI [1]
C1518041
UMLS CUI [2]
C0002842
evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids, or radiation therapy to bones, within 6 months of study enrollment
Beschreibung

Immunosuppression Evidence of | Therapeutic immunosuppression | Chemotherapy | Adrenal Cortex Hormones Dose chronic | Therapeutic radiology procedure Bone

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4048329
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205191
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0262950
current or treatment within 4 weeks with estrogen or estrogenic agents (including herbal compound pc-spes)
Beschreibung

Estrogens | herbal preparation PC-SPES

Datentyp

boolean

Alias
UMLS CUI [1]
C0014939
UMLS CUI [2]
C0756934
current or treatment within 4 weeks with herbal compounds for prostate cancer such as pc-spes or saw palmetto
Beschreibung

Plant Preparations Prostate carcinoma | PC-SPES | Saw palmetto extract

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0949854
UMLS CUI [1,2]
C0600139
UMLS CUI [2]
C0756934
UMLS CUI [3]
C0771607
current or treatment within 4 weeks with megestrol
Beschreibung

Megestrol

Datentyp

boolean

Alias
UMLS CUI [1]
C0025175
current or prior treatment with a bisphosphonate, calcitonin, or other bone resorptive/anabolic agents
Beschreibung

Diphosphonates | Calcitonin | Pharmaceutical Preparations Bone Resorption | Anabolic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0006668
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0005974
UMLS CUI [4]
C1258800
current use of oral corticosteroids or any such use within the past 6 months
Beschreibung

Adrenal Cortex Hormones Oral

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
current use of potentially bone-toxic anticonvulsants (phenytoin, or carbamazepine)
Beschreibung

Anticonvulsants Toxic effect Bone | Phenytoin | Carbamazepine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003286
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C0262950
UMLS CUI [2]
C0031507
UMLS CUI [3]
C0006949
history of orchiectomy
Beschreibung

Orchiectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0029189
hypocalcemia
Beschreibung

Hypocalcemia

Datentyp

boolean

Alias
UMLS CUI [1]
C0020598
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Ähnliche Modelle

Eligibility Prostate Cancer NCT00582556

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
must have a histologic diagnosis of adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Neoplasm Metastasis | Operative Surgical Procedures | Prostate specific antigen measurement Quantity | Therapeutic radiology procedure Ablation | Serum Prostate Specific Antigen Increased Quantity | PSA Failure Evidence of
Item
for patients without clinical metastasis treated by surgery, serum psa values must be > 0.2 ng/ml by two measurements at least two weeks apart. in patients treated with ablative radiation therapy without clinical metastasis, three consecutive increases in serum psa must be documented, with at least a one-month interval between values with the final psa > 2ng/m as evidence of biochemical psa failure. p
boolean
C0027627 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0201544 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4,1])
C0547070 (UMLS CUI [4,2])
C1883014 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C2985506 (UMLS CUI [6,1])
C0332120 (UMLS CUI [6,2])
First line treatment | Therapeutic radiology procedure | Operative Surgical Procedures | Prostate specific antigen measurement | Prostate-Specific Antigen Detectable
Item
patients who have not had prior primary therapy such as radiation or surgery, are required to have a detectable psa of at least 0.2 ng/ml.
boolean
C1708063 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C0201544 (UMLS CUI [4])
C0138741 (UMLS CUI [5,1])
C3830527 (UMLS CUI [5,2])
Neoplasm Metastasis Evidence of | Prostate specific antigen measurement
Item
patients with evidence of metastatic disease are eligible irrespective of serum psa level.
boolean
C0027627 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
Malignant Neoplasm second Curative treatment | Disease Free of
Item
prior history of a second malignancy is allowed if treated with curative intent and patient has been free of disease greater than five years
boolean
C0006826 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of < 2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
GnRH analog | Androgen Antagonists
Item
prior treatment with a gnrh analogue or anti-androgen.
boolean
C1518041 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
Immunosuppression Evidence of | Therapeutic immunosuppression | Chemotherapy | Adrenal Cortex Hormones Dose chronic | Therapeutic radiology procedure Bone
Item
evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy, chronic treatment dose corticosteroids, or radiation therapy to bones, within 6 months of study enrollment
boolean
C4048329 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205191 (UMLS CUI [4,3])
C1522449 (UMLS CUI [5,1])
C0262950 (UMLS CUI [5,2])
Estrogens | herbal preparation PC-SPES
Item
current or treatment within 4 weeks with estrogen or estrogenic agents (including herbal compound pc-spes)
boolean
C0014939 (UMLS CUI [1])
C0756934 (UMLS CUI [2])
Plant Preparations Prostate carcinoma | PC-SPES | Saw palmetto extract
Item
current or treatment within 4 weeks with herbal compounds for prostate cancer such as pc-spes or saw palmetto
boolean
C0949854 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0756934 (UMLS CUI [2])
C0771607 (UMLS CUI [3])
Megestrol
Item
current or treatment within 4 weeks with megestrol
boolean
C0025175 (UMLS CUI [1])
Diphosphonates | Calcitonin | Pharmaceutical Preparations Bone Resorption | Anabolic Agents
Item
current or prior treatment with a bisphosphonate, calcitonin, or other bone resorptive/anabolic agents
boolean
C0012544 (UMLS CUI [1])
C0006668 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0005974 (UMLS CUI [3,2])
C1258800 (UMLS CUI [4])
Adrenal Cortex Hormones Oral
Item
current use of oral corticosteroids or any such use within the past 6 months
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Anticonvulsants Toxic effect Bone | Phenytoin | Carbamazepine
Item
current use of potentially bone-toxic anticonvulsants (phenytoin, or carbamazepine)
boolean
C0003286 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C0262950 (UMLS CUI [1,3])
C0031507 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
Orchiectomy
Item
history of orchiectomy
boolean
C0029189 (UMLS CUI [1])
Hypocalcemia
Item
hypocalcemia
boolean
C0020598 (UMLS CUI [1])
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