ID

31624

Description

Cross-linked Hyaluronan Gel Reduces Rectal Toxicity Due to Radiation Therapy for Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00882232

Link

https://clinicaltrials.gov/show/NCT00882232

Keywords

Versions (1)
  1. 9/14/18 9/14/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 14, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00882232

English

Eligibility Prostate Cancer NCT00882232

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically-confirmed adenocarcinoma of the prostate, clinical stage t1c-t2c, nx, n0, m0.
Description

Adenocarcinoma of prostate TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007112
UMLS CUI [1,2]
C3258246
2. nodes determined to be negative by imaging methods will be classified as nx. only nodes determined to be negative by surgical sampling will be classified as n0.
Description

Negative Lymph Node Imaging method TNM clinical staging | Negative Lymph Node Sampling TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678034
UMLS CUI [1,2]
C1275506
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0678034
UMLS CUI [2,2]
C0441621
UMLS CUI [2,3]
C3258246
3. prostate cancer biopsy grading by gleason score classification is mandatory.
Description

Prostate carcinoma Biopsy Gleason score

Data type

boolean

Alias
UMLS CUI [1,1]
C0600139
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C3203027
4. no prior pelvic radiotherapy. induction hormonal therapy for less than or equal to 6 months is acceptable.
Description

Radiotherapy to pelvis Absent | Induction Hormone Therapy Acceptable

Data type

boolean

Alias
UMLS CUI [1,1]
C1536155
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C1879533
5. prostate volume by trus < 50 cc prior to hdr brachytherapy.
Description

Prostate volume TRUS | Status pre- High dose rate brachytherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1441416
UMLS CUI [1,2]
C2960324
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0454270
6. prostate specific antigen (psa) less than or equal to 30 ng/ml.
Description

Prostate specific antigen measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201544
7. patient has provided informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. clinical stage t3 or t4.
Description

TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C3258246
2. clinical evidence of lymph node involvement (n1).
Description

Lymph Node Involvement TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0806692
UMLS CUI [1,2]
C3258246
3. clinical evidence of distant metastases (m1).
Description

Distant metastasis TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C3258246
4. radical surgery for carcinoma of the prostate.
Description

Operative Surgical Procedures Radical Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0439807
UMLS CUI [1,3]
C0600139
5. allergy to avian products.
Description

Hypersensitivity Products Avian

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1514468
UMLS CUI [1,3]
C0005595
6. significant mental, medical, or physical impairment.
Description

Mental impairment | Impairment Medical | Physical impairment

Data type

boolean

Alias
UMLS CUI [1]
C0683322
UMLS CUI [2,1]
C0221099
UMLS CUI [2,2]
C0205476
UMLS CUI [3]
C0231171
7. prisoners.
Description

Prisoners

Data type

boolean

Alias
UMLS CUI [1]
C0033167
8. employees of the cancer center of irvine.
Description

Employee Cancer center

Data type

boolean

Alias
UMLS CUI [1,1]
C0599987
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0565990
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Similar models

Eligibility Prostate Cancer NCT00882232

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate TNM clinical staging
Item
1. histologically-confirmed adenocarcinoma of the prostate, clinical stage t1c-t2c, nx, n0, m0.
boolean
C0007112 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Negative Lymph Node Imaging method TNM clinical staging | Negative Lymph Node Sampling TNM clinical staging
Item
2. nodes determined to be negative by imaging methods will be classified as nx. only nodes determined to be negative by surgical sampling will be classified as n0.
boolean
C0678034 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0678034 (UMLS CUI [2,1])
C0441621 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Prostate carcinoma Biopsy Gleason score
Item
3. prostate cancer biopsy grading by gleason score classification is mandatory.
boolean
C0600139 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C3203027 (UMLS CUI [1,3])
Radiotherapy to pelvis Absent | Induction Hormone Therapy Acceptable
Item
4. no prior pelvic radiotherapy. induction hormonal therapy for less than or equal to 6 months is acceptable.
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C1879533 (UMLS CUI [2,3])
Prostate volume TRUS | Status pre- High dose rate brachytherapy
Item
5. prostate volume by trus < 50 cc prior to hdr brachytherapy.
boolean
C1441416 (UMLS CUI [1,1])
C2960324 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C0454270 (UMLS CUI [2,2])
Prostate specific antigen measurement
Item
6. prostate specific antigen (psa) less than or equal to 30 ng/ml.
boolean
C0201544 (UMLS CUI [1])
Informed Consent
Item
7. patient has provided informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
TNM clinical staging
Item
1. clinical stage t3 or t4.
boolean
C3258246 (UMLS CUI [1])
Lymph Node Involvement TNM clinical staging
Item
2. clinical evidence of lymph node involvement (n1).
boolean
C0806692 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Distant metastasis TNM clinical staging
Item
3. clinical evidence of distant metastases (m1).
boolean
C1269798 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Radical Prostate carcinoma
Item
4. radical surgery for carcinoma of the prostate.
boolean
C0543467 (UMLS CUI [1,1])
C0439807 (UMLS CUI [1,2])
C0600139 (UMLS CUI [1,3])
Hypersensitivity Products Avian
Item
5. allergy to avian products.
boolean
C0020517 (UMLS CUI [1,1])
C1514468 (UMLS CUI [1,2])
C0005595 (UMLS CUI [1,3])
Mental impairment | Impairment Medical | Physical impairment
Item
6. significant mental, medical, or physical impairment.
boolean
C0683322 (UMLS CUI [1])
C0221099 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0231171 (UMLS CUI [3])
Prisoners
Item
7. prisoners.
boolean
C0033167 (UMLS CUI [1])
Employee Cancer center
Item
8. employees of the cancer center of irvine.
boolean
C0599987 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,3])
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