Transitional Cell Carcinoma Advanced Locally | Transitional cell carcinoma metastatic | Transitional Cell Carcinoma Inappropriate Curative Surgery | Transitional Cell Carcinoma Inappropriate Therapeutic radiology procedure
Item
1. patients with histologically- or cytologically-confirmed locally advanced or metastatic tcc not amenable to curative surgery or radiation.
boolean
C0007138 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3160869 (UMLS CUI [2])
C0007138 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C0007138 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Disease Progression | Status post First line treatment Platinum-Based | Neoadjuvant Therapy | Adjuvant therapy | Palliative Care
Item
2. documented disease progression (according recist 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
C0030231 (UMLS CUI [5])
Interval Since Cancer treatment
Item
3. an interval of >4 weeks since last anticancer treatment.
boolean
C1272706 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Paraffin Embedded Tissue Block Primary tumor | Paraffin embedded slide Unstained Quantity Primary tumor | Paraffin Embedded Tissue Block Neoplasm Metastasis | Paraffin embedded slide Unstained Quantity Neoplasm Metastasis
Item
4. archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. the most recent archival tissue is mandatory. recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
boolean
C1519524 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C4039662 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0677930 (UMLS CUI [2,4])
C1519524 (UMLS CUI [3,1])
C1533157 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C4039662 (UMLS CUI [4,1])
C1883469 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0027627 (UMLS CUI [4,4])
Measurable lesion Quantity MRI | Measurable lesion Quantity CT
Item
5. at least one measurable lesion by mri or ct-scan
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
ECOG performance status
Item
6. ecog performance status 0-1, in stable medical condition
boolean
C1520224 (UMLS CUI [1])
Organ function | Hemoglobin measurement | Neutrophil count
Item
7. patients must have adequate organ function: hemoglobin ≥ 9 g/100 ml, neutrophils ≥
boolean
C0678852 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Platelet Count measurement | International Normalized Ratio | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum | Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
1,000/mm3, platelets ≥ 100,000/mm, inr ≤ 1.5, total serum bilirubin ≤ 1.5 x uln, alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln (or <5.0 x uln if hepatic metastases are present), creatinine £1.5 x uln, fasting plasma glucose <140mg/dl, hba1c < 8%.
boolean
C0032181 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0494165 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0583513 (UMLS CUI [8])
C0474680 (UMLS CUI [9])
Age | Informed Consent Able
Item
8. patients must be over 18 years old and able to give written informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent prior to beginning protocol specific procedure
boolean
C0021430 (UMLS CUI [1])
Malignant neoplasm of urinary bladder | Exception Transitional Cell Carcinoma
Item
1. non- tcc bladder cancer
boolean
C0005684 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007138 (UMLS CUI [2,2])
Prior Chemotherapy Quantity Disease palliation
Item
2. more than 2 prior chemotherapy regimens given for palliation.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679251 (UMLS CUI [1,3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated
Item
3. concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
CNS metastases Uncontrolled | CNS metastases Symptomatic
Item
4. patient with active uncontrolled or symptomatic central nervous system (cns metastases).
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious
Item
5. significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
boolean
C0018799 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
Other medical condition Uncontrolled | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders | Diabetic - poor control
Item
6. other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C0005779 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Cancer treatment Other
Item
7. other concomitant anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
PI3K Inhibitor | mTOR Inhibitor | Sirolimus | temsirolimus | everolimus
Item
8. previous therapy with pi3k and/or mtor inhibitors (sirolimus, temsirolimus, everolimus)
boolean
C1519050 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
C0072980 (UMLS CUI [3])
C1707080 (UMLS CUI [4])
C0541315 (UMLS CUI [5])
Coumarin | Warfarin | Pharmaceutical Preparations Inducing Torsades de Pointes | CYP3A4 Inhibitors Moderate | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
9. concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of cyp3a4
boolean
C0010206 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0205263 (UMLS CUI [3,2])
C0040479 (UMLS CUI [3,3])
C3850053 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C3850041 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C3850053 (UMLS CUI [6,1])
C0442821 (UMLS CUI [6,2])
C3850041 (UMLS CUI [7,1])
C0442821 (UMLS CUI [7,2])
Pregnancy | At risk Pregnancy
Item
10. pregnancy or risk of pregnancy.
boolean
C0032961 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])