ID

28288

Beskrivning

Study of Biomarkers in Blood & Tissue Samples From Patients With Colorectal Cancer or Polyps & Patients Without Polyps; ODM derived from: https://clinicaltrials.gov/show/NCT00898378

Länk

https://clinicaltrials.gov/show/NCT00898378

Nyckelord

Versioner (1)
  1. 2018-01-02 2018-01-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 januari 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Colorectal Cancer NCT00898378

Engelsk

Eligibility Colorectal Cancer NCT00898378

1 Formulär  
Criteria
Beskrivning

Criteria

meets 1 of the following criteria:
Beskrivning

Criteria Fulfill

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
diagnosis of one of the following:
Beskrivning

Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
stage i or ii colorectal cancer (crc)*
Beskrivning

Colorectal Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo surgery only
Beskrivning

Operative Surgical Procedures Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
stage iii crc*
Beskrivning

Colorectal Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
Beskrivning

Operative Surgical Procedures Planned | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C0085533
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
stage iv crc
Beskrivning

Colorectal Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C3258246
planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
Beskrivning

Chemotherapy Planned | Biological treatment Planned | bevacizumab | cetuximab | panitumumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C0796392
UMLS CUI [4]
C0995188
UMLS CUI [5]
C0879427
colorectal adenomatous polyps
Beskrivning

Adenomatous Polyps Colorectal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206677
UMLS CUI [1,2]
C0555952
planning to undergo colonoscopy
Beskrivning

Colonoscopy Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009378
UMLS CUI [1,2]
C1301732
healthy volunteer
Beskrivning

Healthy Volunteer

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
planning to undergo colonoscopy note: *patients with previously resected stage ii or iii crc are eligible provided they undergo blood sample collection prior to starting chemotherapy
Beskrivning

Colonoscopy Planned | Excision Colorectal Carcinoma TNM clinical staging | Collection of blood specimen | Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009378
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0728940
UMLS CUI [2,2]
C0009402
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C0005834
UMLS CUI [4]
C0392920
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
not pregnant
Beskrivning

Exclusion | Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0032961
able to undergo an 8-hour overnight fast prior to metabolomic testing
Beskrivning

Ability Overnight Fasting | Metabolome Testing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0439583
UMLS CUI [1,3]
C0015663
UMLS CUI [2,1]
C2350399
UMLS CUI [2,2]
C0392366
able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
Beskrivning

Patient Visit Collection of blood specimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C0005834
no prior or concurrent invasive cancer other than crc (for patients with crc)
Beskrivning

Exclusion | Invasive cancer | Exception Colorectal Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0677898
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0009402
no prior invasive cancer and no first-degree relative with a known history of crc (for healthy volunteers and patients with colorectal polyps)
Beskrivning

Exclusion Criteria | Invasive cancer | Colorectal Carcinoma First Degree Relative

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0677898
UMLS CUI [3,1]
C0009402
UMLS CUI [3,2]
C1517194
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beskrivning

ID.20

Datatyp

boolean

Tillbaka till toppen

Similar models

Eligibility Colorectal Cancer NCT00898378

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Criteria Fulfill
Item
meets 1 of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Diagnosis
Item
diagnosis of one of the following:
boolean
C0011900 (UMLS CUI [1])
Colorectal Carcinoma TNM clinical staging
Item
stage i or ii colorectal cancer (crc)*
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Planned
Item
planning to undergo surgery only
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Colorectal Carcinoma TNM clinical staging
Item
stage iii crc*
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Operative Surgical Procedures Planned | Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant
Item
planning to undergo surgery followed by adjuvant chemotherapy with or without neoadjuvant chemoradiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0085533 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Colorectal Carcinoma TNM clinical staging
Item
stage iv crc
boolean
C0009402 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Chemotherapy Planned | Biological treatment Planned | bevacizumab | cetuximab | panitumumab
Item
planning to undergo chemotherapy and biologic therapy (bevacizumab, cetuximab, or panitumumab)
boolean
C0392920 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0796392 (UMLS CUI [3])
C0995188 (UMLS CUI [4])
C0879427 (UMLS CUI [5])
Adenomatous Polyps Colorectal
Item
colorectal adenomatous polyps
boolean
C0206677 (UMLS CUI [1,1])
C0555952 (UMLS CUI [1,2])
Colonoscopy Planned
Item
planning to undergo colonoscopy
boolean
C0009378 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Healthy Volunteer
Item
healthy volunteer
boolean
C1708335 (UMLS CUI [1])
Colonoscopy Planned | Excision Colorectal Carcinoma TNM clinical staging | Collection of blood specimen | Chemotherapy
Item
planning to undergo colonoscopy note: *patients with previously resected stage ii or iii crc are eligible provided they undergo blood sample collection prior to starting chemotherapy
boolean
C0009378 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0728940 (UMLS CUI [2,1])
C0009402 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0005834 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Exclusion | Pregnancy
Item
not pregnant
boolean
C2828389 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Ability Overnight Fasting | Metabolome Testing
Item
able to undergo an 8-hour overnight fast prior to metabolomic testing
boolean
C0085732 (UMLS CUI [1,1])
C0439583 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
C2350399 (UMLS CUI [2,1])
C0392366 (UMLS CUI [2,2])
Patient Visit Collection of blood specimen
Item
able to attend follow-up or treatment visits for up to 24 months for collection of blood samples
boolean
C1512346 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Exclusion | Invasive cancer | Exception Colorectal Carcinoma
Item
no prior or concurrent invasive cancer other than crc (for patients with crc)
boolean
C2828389 (UMLS CUI [1])
C0677898 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0009402 (UMLS CUI [3,2])
Exclusion Criteria | Invasive cancer | Colorectal Carcinoma First Degree Relative
Item
no prior invasive cancer and no first-degree relative with a known history of crc (for healthy volunteers and patients with colorectal polyps)
boolean
C0680251 (UMLS CUI [1])
C0677898 (UMLS CUI [2])
C0009402 (UMLS CUI [3,1])
C1517194 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.20
Item
see disease characteristics
boolean
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial