ID

36411

Description

Cyclin D1 Based TPF Induction Chemotherapy for Oral Squamous Cell Carcinoma Patients at Clinical N2 Stage; ODM derived from: https://clinicaltrials.gov/show/NCT02290145

Link

https://clinicaltrials.gov/show/NCT02290145

Keywords

Versions (1)
  1. 5/12/19 5/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Mouth Neoplasms NCT02290145

English

Eligibility Mouth Neoplasms NCT02290145

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 18 to 75 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sex: both males and females.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
karnofsky performance status (kps) >60.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
Description

Squamous cell carcinoma of mouth | Squamous cell carcinoma of tongue | Squamous cell carcinoma of gum | Squamous cell carcinoma of buccal mucosa | Squamous cell carcinoma of floor of mouth | Squamous cell carcinoma of palate | Squamous cell carcinoma Retromolar region

Data type

boolean

Alias
UMLS CUI [1]
C0585362
UMLS CUI [2]
C0349566
UMLS CUI [3]
C0349567
UMLS CUI [4]
C0280299
UMLS CUI [5]
C0280300
UMLS CUI [6]
C0349568
UMLS CUI [7,1]
C0007137
UMLS CUI [7,2]
C4247023
cyclin d1 high expression
Description

Cyclin D1 Expression High

Data type

boolean

Alias
UMLS CUI [1,1]
C0174680
UMLS CUI [1,2]
C0017262
UMLS CUI [1,3]
C0205250
clinical stage iii/iva (t1-2, n2, m0 or t3-4, n2, m0, uicc[international union against cancer] 2002) with resectable lesions.
Description

TNM clinical staging | Lesion Resectable

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1514888
adequate hematologic function: white blood cell >3,000/mm3, hemoglobin>8g/l, platelet count>80,000/mm3.
Description

Hematologic function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
hepatic function: alat(alanine aminotransferase)/asat(aspartate transaminase) <2.5 times the upper limit of normal (uln), bilirubin <1.5 times uln.
Description

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
renal function: serum creatinine <1.5 times uln.
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of distant metastatic disease and other cancers.
Description

Distant metastasis | Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C1707251
surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
Description

Operative Surgical Procedures Primary tumor | Operative Surgical Procedures Lymph nodes | Exception Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0024204
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0005558
previous radiotherapy or chemotherapy.
Description

Prior radiation therapy | Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514457
other previous malignancies within 5 years.
Description

Cancer Other Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205156
can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
Description

Treatment Protocol Receive Unable | Systemic disease | Lung disease Severe | Heart Disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0040808
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
UMLS CUI [2]
C0442893
UMLS CUI [3,1]
C0024115
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205082
legal incapacity or limited legal capacity.
Description

Legal capacity Lacking | Legal capacity Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0683673
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
creatinine clearance <30ml/min.
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
pregnancy (confirmed by serum or urine β-hcg) or lactation period.
Description

Pregnancy Serum Beta-HCG Test | Pregnancy Urine pregnancy test | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1255526
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0430056
UMLS CUI [3]
C0006147
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Similar models

Eligibility Mouth Neoplasms NCT02290145

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 18 to 75 years old.
boolean
C0001779 (UMLS CUI [1])
Gender
Item
sex: both males and females.
boolean
C0079399 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status (kps) >60.
boolean
C0206065 (UMLS CUI [1])
Squamous cell carcinoma of mouth | Squamous cell carcinoma of tongue | Squamous cell carcinoma of gum | Squamous cell carcinoma of buccal mucosa | Squamous cell carcinoma of floor of mouth | Squamous cell carcinoma of palate | Squamous cell carcinoma Retromolar region
Item
histological biopsy confirming squamous cell carcinoma of the oral cavity (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region).
boolean
C0585362 (UMLS CUI [1])
C0349566 (UMLS CUI [2])
C0349567 (UMLS CUI [3])
C0280299 (UMLS CUI [4])
C0280300 (UMLS CUI [5])
C0349568 (UMLS CUI [6])
C0007137 (UMLS CUI [7,1])
C4247023 (UMLS CUI [7,2])
Cyclin D1 Expression High
Item
cyclin d1 high expression
boolean
C0174680 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,3])
TNM clinical staging | Lesion Resectable
Item
clinical stage iii/iva (t1-2, n2, m0 or t3-4, n2, m0, uicc[international union against cancer] 2002) with resectable lesions.
boolean
C3258246 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1514888 (UMLS CUI [2,2])
Hematologic function | White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
adequate hematologic function: white blood cell >3,000/mm3, hemoglobin>8g/l, platelet count>80,000/mm3.
boolean
C0221130 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
hepatic function: alat(alanine aminotransferase)/asat(aspartate transaminase) <2.5 times the upper limit of normal (uln), bilirubin <1.5 times uln.
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
renal function: serum creatinine <1.5 times uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Distant metastasis | Cancer Other
Item
evidence of distant metastatic disease and other cancers.
boolean
C1269798 (UMLS CUI [1])
C1707251 (UMLS CUI [2])
Operative Surgical Procedures Primary tumor | Operative Surgical Procedures Lymph nodes | Exception Biopsy
Item
surgical procedure of the primary tumors or lymph nodes (except diagnostic biopsy).
boolean
C0543467 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0024204 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Prior radiation therapy | Prior Chemotherapy
Item
previous radiotherapy or chemotherapy.
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Cancer Other Previous
Item
other previous malignancies within 5 years.
boolean
C1707251 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Treatment Protocol Receive Unable | Systemic disease | Lung disease Severe | Heart Disease Severe
Item
can not tolerate the treatment protocol with systematic diseases such as history of severe pulmonary or cardiac diseases.
boolean
C0040808 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0442893 (UMLS CUI [2])
C0024115 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Legal capacity Lacking | Legal capacity Limited
Item
legal incapacity or limited legal capacity.
boolean
C0683673 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Creatinine clearance measurement
Item
creatinine clearance <30ml/min.
boolean
C0373595 (UMLS CUI [1])
Pregnancy Serum Beta-HCG Test | Pregnancy Urine pregnancy test | Breast Feeding
Item
pregnancy (confirmed by serum or urine β-hcg) or lactation period.
boolean
C0032961 (UMLS CUI [1,1])
C1255526 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
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