ID

36900

Beskrivning

Use of a Biodegradable Balloon for the Treatment of Prostate Cancer by Intensity Modulated Radiotherapy (BioPro-RCMI); ODM derived from: https://clinicaltrials.gov/show/NCT02478112

Länk

https://clinicaltrials.gov/show/NCT02478112

Nyckelord

Versioner (1)
  1. 2019-06-19 2019-06-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 juni 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT02478112

Engelsk

Eligibility Prostate Cancer NCT02478112

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient over 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. with a localized adenocarcinoma of the prostate
Beskrivning

Adenocarcinoma of prostate Localized

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C0392752
of intermediate risk of d'amico
Beskrivning

Intermediate Risk | Risk Classification Prostate carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C3640764
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0008902
UMLS CUI [2,3]
C0600139
and of stage mri < t3
Beskrivning

TNM clinical staging MRI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0024485
3. requiring a treatment with intensity modulated radiotherapy
Beskrivning

Requirement Intensity-Modulated Radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1512814
4. psa (prostate-specific antigen) levels ≤ 20 ng/ml before external beam radiotherapy
Beskrivning

Prostate specific antigen measurement | Status pre- Teleradiotherapy procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0419095
5. prostate volume > 15 cc
Beskrivning

Prostate volume

Datatyp

boolean

Alias
UMLS CUI [1]
C1441416
6. short hormone therapy possibly associated (4-6 months)
Beskrivning

Hormone Therapy Short

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1806781
7. patient without clinical signs of progressive disease (performing a bone scan and a ct scan is optional)
Beskrivning

Sign or Symptom Absent Progressive Disease | Bone scan Optional | CT Scan Optional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1335499
UMLS CUI [2,1]
C0203668
UMLS CUI [2,2]
C1518600
UMLS CUI [3,1]
C0040405
UMLS CUI [3,2]
C1518600
8. performance status ecog (eastern cooperative oncology group) ≤ 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
9. life expectancy ≥ 10 years
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
10. informed consent signed
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. incompatibility to the implantation of a bioprotect balloon :
Beskrivning

Incompatibility Implantation Balloon

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679426
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C1704777
ongoing anticoagulant by vitamin k antagonist (vka) or heparintherapy
Beskrivning

Anticoagulant therapy | Treatment with Vitamin K antagonist | Heparin therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0150457
UMLS CUI [2]
C1096489
UMLS CUI [3]
C0522794
patient with immunosuppression or with serious chronic diseases such as heart failure, cirrhosis, chronic kidney failure, colic or rectal digestive inflammatory disease
Beskrivning

Immunosuppression | Chronic disease Serious | Heart failure | Liver Cirrhosis | Kidney Failure, Chronic | Inflammatory disorder of digestive system colonic | Inflammatory disorder of digestive system rectal

Datatyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018801
UMLS CUI [4]
C0023890
UMLS CUI [5]
C0022661
UMLS CUI [6,1]
C1298758
UMLS CUI [6,2]
C0009368
UMLS CUI [7,1]
C1298758
UMLS CUI [7,2]
C0205052
history of prostatitis or of lower gastrointestinal infection treated or ongoing
Beskrivning

Prostatitis Treated | Lower Gastrointestinal Tract Communicable Disease Treated | Prostatitis | Lower Gastrointestinal Tract Communicable Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0033581
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C0226875
UMLS CUI [2,2]
C0009450
UMLS CUI [2,3]
C1522326
UMLS CUI [3]
C0033581
UMLS CUI [4,1]
C0226875
UMLS CUI [4,2]
C0009450
history of recto-colic inflammatory disease or of repeated prostatic resections
Beskrivning

Inflammatory disorder Colorectal | Prostatectomy Repeated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0555952
UMLS CUI [2,1]
C0033573
UMLS CUI [2,2]
C0205341
untreated perineal wound
Beskrivning

Wound perineal untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043250
UMLS CUI [1,2]
C0031066
UMLS CUI [1,3]
C0332155
2. prior treatment with hormone therapy
Beskrivning

Prior Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1514460
3. history of another invasive cancer within 5 years prior to study entry (with the exception of a treated basal cell skin carcinoma)
Beskrivning

Cancer Other Invasive | Exception Basal cell carcinoma Treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
4. history of pelvic radiotherapy
Beskrivning

Radiotherapy to pelvis

Datatyp

boolean

Alias
UMLS CUI [1]
C1536155
5. severe hypertension non controlled by an adapted treatment (≥ 160 mm hg in systole and/or ≥ 90 mm hg in diastole)
Beskrivning

Uncontrolled hypertension Severe | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
6. ongoing antineoplastic therapy
Beskrivning

Antineoplastic Drug/Agent Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2346834
7. person deprived of liberty or under tutorship
Beskrivning

Person Deprivation Freedom | Person Guardianship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027361
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2,1]
C0027361
UMLS CUI [2,2]
C0870627
8. inability to submit to the medical monitoring of the study for geographical, social or psychological reasons.
Beskrivning

Geographic Factors Patient Monitoring Unsuccessful | Social situation Patient Monitoring Unsuccessful | Psychological Factors Patient Monitoring Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017444
UMLS CUI [1,2]
C0030695
UMLS CUI [1,3]
C1272705
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0030695
UMLS CUI [2,3]
C1272705
UMLS CUI [3,1]
C0033898
UMLS CUI [3,2]
C0030695
UMLS CUI [3,3]
C1272705
9. conformal radiotherapy without intensity modulation
Beskrivning

Radiotherapy, Conformal | Intensity Modulation Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0600521
UMLS CUI [2,1]
C0522510
UMLS CUI [2,2]
C0443264
UMLS CUI [2,3]
C0332197
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Similar models

Eligibility Prostate Cancer NCT02478112

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient over 18 years old
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma of prostate Localized
Item
2. with a localized adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
Intermediate Risk | Risk Classification Prostate carcinoma
Item
of intermediate risk of d'amico
boolean
C3640764 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
TNM clinical staging MRI
Item
and of stage mri < t3
boolean
C3258246 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Requirement Intensity-Modulated Radiotherapy
Item
3. requiring a treatment with intensity modulated radiotherapy
boolean
C1514873 (UMLS CUI [1,1])
C1512814 (UMLS CUI [1,2])
Prostate specific antigen measurement | Status pre- Teleradiotherapy procedure
Item
4. psa (prostate-specific antigen) levels ≤ 20 ng/ml before external beam radiotherapy
boolean
C0201544 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0419095 (UMLS CUI [2,2])
Prostate volume
Item
5. prostate volume > 15 cc
boolean
C1441416 (UMLS CUI [1])
Hormone Therapy Short
Item
6. short hormone therapy possibly associated (4-6 months)
boolean
C0279025 (UMLS CUI [1,1])
C1806781 (UMLS CUI [1,2])
Sign or Symptom Absent Progressive Disease | Bone scan Optional | CT Scan Optional
Item
7. patient without clinical signs of progressive disease (performing a bone scan and a ct scan is optional)
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1335499 (UMLS CUI [1,3])
C0203668 (UMLS CUI [2,1])
C1518600 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3,1])
C1518600 (UMLS CUI [3,2])
ECOG performance status
Item
8. performance status ecog (eastern cooperative oncology group) ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
9. life expectancy ≥ 10 years
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
10. informed consent signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Incompatibility Implantation Balloon
Item
1. incompatibility to the implantation of a bioprotect balloon :
boolean
C0679426 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C1704777 (UMLS CUI [1,3])
Anticoagulant therapy | Treatment with Vitamin K antagonist | Heparin therapy
Item
ongoing anticoagulant by vitamin k antagonist (vka) or heparintherapy
boolean
C0150457 (UMLS CUI [1])
C1096489 (UMLS CUI [2])
C0522794 (UMLS CUI [3])
Immunosuppression | Chronic disease Serious | Heart failure | Liver Cirrhosis | Kidney Failure, Chronic | Inflammatory disorder of digestive system colonic | Inflammatory disorder of digestive system rectal
Item
patient with immunosuppression or with serious chronic diseases such as heart failure, cirrhosis, chronic kidney failure, colic or rectal digestive inflammatory disease
boolean
C4048329 (UMLS CUI [1])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3])
C0023890 (UMLS CUI [4])
C0022661 (UMLS CUI [5])
C1298758 (UMLS CUI [6,1])
C0009368 (UMLS CUI [6,2])
C1298758 (UMLS CUI [7,1])
C0205052 (UMLS CUI [7,2])
Prostatitis Treated | Lower Gastrointestinal Tract Communicable Disease Treated | Prostatitis | Lower Gastrointestinal Tract Communicable Disease
Item
history of prostatitis or of lower gastrointestinal infection treated or ongoing
boolean
C0033581 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0226875 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0033581 (UMLS CUI [3])
C0226875 (UMLS CUI [4,1])
C0009450 (UMLS CUI [4,2])
Inflammatory disorder Colorectal | Prostatectomy Repeated
Item
history of recto-colic inflammatory disease or of repeated prostatic resections
boolean
C1290884 (UMLS CUI [1,1])
C0555952 (UMLS CUI [1,2])
C0033573 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
Wound perineal untreated
Item
untreated perineal wound
boolean
C0043250 (UMLS CUI [1,1])
C0031066 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Prior Hormone Therapy
Item
2. prior treatment with hormone therapy
boolean
C1514460 (UMLS CUI [1])
Cancer Other Invasive | Exception Basal cell carcinoma Treated
Item
3. history of another invasive cancer within 5 years prior to study entry (with the exception of a treated basal cell skin carcinoma)
boolean
C1707251 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Radiotherapy to pelvis
Item
4. history of pelvic radiotherapy
boolean
C1536155 (UMLS CUI [1])
Uncontrolled hypertension Severe | Systolic Pressure | Diastolic blood pressure
Item
5. severe hypertension non controlled by an adapted treatment (≥ 160 mm hg in systole and/or ≥ 90 mm hg in diastole)
boolean
C1868885 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Antineoplastic Drug/Agent Therapy
Item
6. ongoing antineoplastic therapy
boolean
C2346834 (UMLS CUI [1])
Person Deprivation Freedom | Person Guardianship
Item
7. person deprived of liberty or under tutorship
boolean
C0027361 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0027361 (UMLS CUI [2,1])
C0870627 (UMLS CUI [2,2])
Geographic Factors Patient Monitoring Unsuccessful | Social situation Patient Monitoring Unsuccessful | Psychological Factors Patient Monitoring Unsuccessful
Item
8. inability to submit to the medical monitoring of the study for geographical, social or psychological reasons.
boolean
C0017444 (UMLS CUI [1,1])
C0030695 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0030695 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0033898 (UMLS CUI [3,1])
C0030695 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
Radiotherapy, Conformal | Intensity Modulation Absent
Item
9. conformal radiotherapy without intensity modulation
boolean
C0600521 (UMLS CUI [1])
C0522510 (UMLS CUI [2,1])
C0443264 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
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