Item
What is the best overall response assessed during the study?
integer
C2986560 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Code List
What is the best overall response assessed during the study?
If CR, was there a suspicion of residual disease?
Item
If CR, was there a suspicion of residual disease?
boolean
C0677874 (UMLS CUI [1])
C0543478 (UMLS CUI [2])
If suspicion of residual disease, was CR status been confirmed by cytology?
Item
If suspicion of residual disease, was CR status been confirmed by cytology?
boolean
C0543478 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
C0677874 (UMLS CUI [2])
C0750484 (UMLS CUI [3,1])
C0010819 (UMLS CUI [3,2])
Date of first documented [ CR ], [ PR ] response
Item
Date of first documented [ CR ], [ PR ] response
date
C0677874 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C0011008 (UMLS CUI [3,1])
C0920316 (UMLS CUI [3,2])
C0205435 (UMLS CUI [3,3])
Date of best response confirmation [ CR ], [ PR ]:
Item
Date of best response confirmation [ CR ], [ PR ]:
date
C0011008 (UMLS CUI [1])
C2986560 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C0677874 (UMLS CUI [3])
C1521726 (UMLS CUI [4])
If [ SD ], [SD/PR*]: Date of last documented stable disease:
Item
If [ SD ], [SD/PR*]: Date of last documented stable disease:
date
C0677946 (UMLS CUI [1])
C1521726 (UMLS CUI [2])
C1517741 (UMLS CUI [3,1])
C1301725 (UMLS CUI [3,2])
C0011008 (UMLS CUI [3,3])
Has the patient developed a recurrence / Progressive disease?
Item
Has the patient developed a recurrence / Progressive disease?
boolean
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Recurrence / Progressive disease date
Item
Recurrence / Progressive disease date
date
C1335499 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
Has the recurrence / progressive disease been histologically or cytologically confirmed?
Item
Has the recurrence / progressive disease been histologically or cytologically confirmed?
boolean
C1335499 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0750484 (UMLS CUI [3,1])
C0205462 (UMLS CUI [3,2])
C0750484 (UMLS CUI [4,1])
C0205471 (UMLS CUI [4,2])
Item
Please specify the method used to confirm the recurrence / progressive disease:
integer
C0277556 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0750484 (UMLS CUI [2,2])
C2348235 (UMLS CUI [3,1])
C0871511 (UMLS CUI [3,2])
Code List
Please specify the method used to confirm the recurrence / progressive disease:
CL Item
Histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression. (2)
CL Item
Cytology and histology → Please complete ICF section for MAGE-A3 Expression testing and for gene profiling of newly resected tumors in case of disease progression. (3)
Item
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
text
C0021430 (UMLS CUI [1])
C0962473 (UMLS CUI [2,1])
C0017262 (UMLS CUI [2,2])
C0022885 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])
C0027651 (UMLS CUI [3,3])
C0242656 (UMLS CUI [4])
Code List
Has the informed consent been signed for MAGE-A3 expression testing and gene profiling of newly resected tumors in case of disease progression
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Has a new fresh biopsy been collected?
Item
Has a new fresh biopsy been collected?
boolean
C0005558 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,3])
Date of biopsy (fresh biopsy)
Item
Date of biopsy (fresh biopsy)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Requisition number (fresh biopsy)
Item
Requisition number (fresh biopsy)
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Item
Tumor biopsy type (fresh biopsy)
integer
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
Code List
Tumor biopsy type (fresh biopsy)
CL Item
Other, specify (4)
If other tumor biopsy type, specify (fresh biopsy)
Item
If other tumor biopsy type, specify (fresh biopsy)
text
C0475358 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0005558 (UMLS CUI [4,1])
C2827486 (UMLS CUI [4,2])
Item
What is the status of the lesion resected? (fresh biopsy)
integer
C0728940 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
C0005558 (UMLS CUI [3,1])
C2827486 (UMLS CUI [3,2])
Code List
What is the status of the lesion resected? (fresh biopsy)
CL Item
Progressive target lesion (2)
CL Item
Progressive non-target lesion (3)
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
Item
Has a new Formalin fixed Paraffin embedded (FFPE) been collected?
boolean
C0475358 (UMLS CUI [1,1])
C2711483 (UMLS CUI [1,2])
C1516698 (UMLS CUI [2])
C0205314 (UMLS CUI [3])
Date of biopsy (FFPE)
Item
Date of biopsy (FFPE)
date
C0005558 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Requisition number (FFPE):
Item
Requisition number (FFPE):
text
C1514821 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C2711483 (UMLS CUI [2])
Item
Tumor block or tumor slides? (FFPE)
integer
C0475358 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2317347 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0026017 (UMLS CUI [2,2])
C2711483 (UMLS CUI [3])
Code List
Tumor block or tumor slides? (FFPE)
Number of tumor slides sent (FFPE)
Item
Number of tumor slides sent (FFPE)
integer
C0027651 (UMLS CUI [1,1])
C0026017 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2711483 (UMLS CUI [2])
Does the FFPE come from the same lesion as the fresh biopsy?
Item
Does the FFPE come from the same lesion as the fresh biopsy?
boolean
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
Item
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
integer
C2711483 (UMLS CUI [1])
C0677862 (UMLS CUI [2,1])
C2827486 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C0445247 (UMLS CUI [3,2])
C2347029 (UMLS CUI [4])
Code List
If the FFPE does not come from the same lesion as the fresh biopsy, enter FFPE sample type
CL Item
Other, please specify (4)
Other FFPE sample type
Item
Other FFPE sample type
text
C2711483 (UMLS CUI [1])
C2347029 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
What is the status of the lesion resected? (FFPE)
integer
C0728940 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
C2711483 (UMLS CUI [3])
Code List
What is the status of the lesion resected? (FFPE)
CL Item
Progressive target lesion (2)
CL Item
Progressive non-target lesion (3)
Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
Item
Did the patient receive any anti-cancer treatment before biopsy (other than study treatment)?
boolean
C0920425 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0949266 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])