ID

37720

Beskrivning

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

Nyckelord

Versioner (1)
  1. 2019-08-20 2019-08-20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

20 augusti 2019

DOI

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Creative Commons BY-NC 3.0
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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886

Engelsk

Response Assessment

1 Formulär  
  1. StudyEvent: ODM
    1. Response Assessment
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Center number
Beskrivning

Study Coordinating Center, Identification number

Datatyp

integer

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1300638
Patient Number
Beskrivning

Patient number

Datatyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beskrivning

Person Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
TNM Staging
Beskrivning

TNM Staging

Alias
UMLS CUI-1
C3258246
T
Beskrivning

TNM clinical staging, primary tumor

Datatyp

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0677930
N
Beskrivning

TNM clinical staging, Lymph nodes

Datatyp

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0024204
M
Beskrivning

TNM clinical staging, Neoplasm Metastasis

Datatyp

text

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0027627
Tumor size - H
Beskrivning

Tumor size, Height

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0489786
cm
Tumor size - W
Beskrivning

Tumor size, Width

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C0487742
cm
Tumor size - D
Beskrivning

Tumor size, Diameter

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1301886
cm
Ulceration
Beskrivning

TNM clinical staging, Ulceration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C3887532
Pathological Staging
Beskrivning

Pathological Staging

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C0443276
Pathological Staging
Beskrivning

Rectal Carcinoma, Pathological staging

Datatyp

text

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0443276
Sphincter Preservation
Beskrivning

Sphincter Preservation

Alias
UMLS CUI-1
C0007113
UMLS CUI-2
C1409894
UMLS CUI-3
C1514402
Was the Sphincter Preserved?
Beskrivning

Rectal Carcinoma, Sphincter, Preservation technique

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C1409894
UMLS CUI [1,3]
C1514402
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Similar models

Response Assessment

1 Formulär
  1. StudyEvent: ODM
    1. Response Assessment
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Item Group
TNM Staging
C3258246 (UMLS CUI-1)
TNM clinical staging, primary tumor
Item
T
text
C3258246 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
TNM clinical staging, Lymph nodes
Item
N
text
C3258246 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
TNM clinical staging, Neoplasm Metastasis
Item
M
text
C3258246 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
Tumor size, Height
Item
Tumor size - H
float
C0475440 (UMLS CUI [1,1])
C0489786 (UMLS CUI [1,2])
Tumor size, Width
Item
Tumor size - W
float
C0475440 (UMLS CUI [1,1])
C0487742 (UMLS CUI [1,2])
Tumor size, Diameter
Item
Tumor size - D
float
C0475440 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
TNM clinical staging, Ulceration
Item
Ulceration
boolean
C3258246 (UMLS CUI [1,1])
C3887532 (UMLS CUI [1,2])
Item Group
Pathological Staging
C0007113 (UMLS CUI-1)
C0443276 (UMLS CUI-2)
Item
Pathological Staging
text
C0007113 (UMLS CUI [1,1])
C0443276 (UMLS CUI [1,2])
Rectal Carcinoma, Pathological staging
Code List
Pathological Staging
CL Item
No cancer cells present (1)
CL Item
Few cancer cells present, - >= 75% Necrosis (2)
CL Item
Large tumor, < 75% Necrosis (3)
Item Group
Sphincter Preservation
C0007113 (UMLS CUI-1)
C1409894 (UMLS CUI-2)
C1514402 (UMLS CUI-3)
Rectal Carcinoma, Sphincter, Preservation technique
Item
Was the Sphincter Preserved?
boolean
C0007113 (UMLS CUI [1,1])
C1409894 (UMLS CUI [1,2])
C1514402 (UMLS CUI [1,3])
Tillbaka till toppen 

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