ID

28302

Description

Study to Identify Mechanisms of Resistance to Standard Therapy in Patients With Metastatic Colorectal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00984048

Link

https://clinicaltrials.gov/show/NCT00984048

Keywords

Versions (1)
  1. 1/3/18 1/3/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 3, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT00984048

English

Eligibility Colorectal Cancer NCT00984048

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with a histologically confirmed diagnosis of colorectal cancer, with at least one liver metastasis site available for biopsy.
Description

Colorectal Carcinoma | Secondary malignant neoplasm of liver | Site Quantity Availability Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2]
C0494165
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0470187
UMLS CUI [3,4]
C0005558
2. for patients with liver only disease, patients deemed not to be initially resectable
Description

Liver disease unresectable Initially

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C0205265
3. scheduled to receive first-line chemotherapy (folfox/bevacizumab or folfiri/bevacizumab) for metastatic disease.
Description

First line Chemotherapy Scheduled Neoplasm Metastasis | FOLFOX Regimen | bevacizumab | FOLFIRI Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C0205539
UMLS CUI [1,4]
C0027627
UMLS CUI [2]
C0392943
UMLS CUI [3]
C0796392
UMLS CUI [4]
C1880658
4. measurable metastatic disease (at least one unidimensionally measurable lesion) present after planned biopsy of metastatic site(s).
Description

Neoplasm Metastasis Measurable | Measurable lesion Linear Quantity | Metastatic cancer site Biopsy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0205132
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0280457
UMLS CUI [3,2]
C0005558
UMLS CUI [3,3]
C1301732
5. ecog 0, 1 or 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. life expectancy of 12 or more weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. able to adhere to the study visit schedule and other protocol requirements.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
9. normal coagulation profile (pt, ptt, inr).
Description

Coagulation profile Normal | Prothrombin time | PTT | INR

Data type

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0205307
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
UMLS CUI [4]
C0525032
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with initially resectable liver only metastases
Description

Secondary malignant neoplasm of liver Resectable Initially

Data type

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C1514888
UMLS CUI [1,3]
C0205265
2. have received prior therapy for metastatic cancer. prior adjuvant therapy is allowed.
Description

Prior Therapy Neoplasm Metastasis | Adjuvant therapy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0683607
3. inadequate or unusable tissue as the only tissue available for biopsy.
Description

Tissue specimen Inadequate Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C0205412
UMLS CUI [1,3]
C0005558
4. contraindication to any of the components of the the first-line chemotherapy regimen.
Description

Medical contraindication First line Chemotherapy Regimen Component

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1705248
5. known brain metastases or meningeal disease.
Description

Metastatic malignant neoplasm to brain | Meningeal disorder

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0154728
6. female patients who are pregnant or breastfeeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. concurrent treatment with other anti-cancer therapy (palliative radiation is allowed but patients must have a metastatic site available for re-biopsy that has not been irradiated).
Description

Cancer treatment Other | Palliative Radiation Therapy allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C3898008
UMLS CUI [2,2]
C0683607
8. abnormal coagulation profile, any anti-coagulant therapy.
Description

Abnormal coagulation profile | Anticoagulant therapy

Data type

boolean

Alias
UMLS CUI [1]
C0375576
UMLS CUI [2]
C0150457
9. known infection with hiv.
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Colorectal Cancer NCT00984048

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma | Secondary malignant neoplasm of liver | Site Quantity Availability Biopsy
Item
1. patients with a histologically confirmed diagnosis of colorectal cancer, with at least one liver metastasis site available for biopsy.
boolean
C0009402 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
C1515974 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0470187 (UMLS CUI [3,3])
C0005558 (UMLS CUI [3,4])
Liver disease unresectable Initially
Item
2. for patients with liver only disease, patients deemed not to be initially resectable
boolean
C0023895 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
First line Chemotherapy Scheduled Neoplasm Metastasis | FOLFOX Regimen | bevacizumab | FOLFIRI Regimen
Item
3. scheduled to receive first-line chemotherapy (folfox/bevacizumab or folfiri/bevacizumab) for metastatic disease.
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
C0392943 (UMLS CUI [2])
C0796392 (UMLS CUI [3])
C1880658 (UMLS CUI [4])
Neoplasm Metastasis Measurable | Measurable lesion Linear Quantity | Metastatic cancer site Biopsy Planned
Item
4. measurable metastatic disease (at least one unidimensionally measurable lesion) present after planned biopsy of metastatic site(s).
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0205132 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0280457 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
ECOG performance status
Item
5. ecog 0, 1 or 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of 12 or more weeks.
boolean
C0023671 (UMLS CUI [1])
Age
Item
7. age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
8. able to adhere to the study visit schedule and other protocol requirements.
boolean
C0525058 (UMLS CUI [1])
Coagulation profile Normal | Prothrombin time | PTT | INR
Item
9. normal coagulation profile (pt, ptt, inr).
boolean
C0005790 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Secondary malignant neoplasm of liver Resectable Initially
Item
1. patients with initially resectable liver only metastases
boolean
C0494165 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,3])
Prior Therapy Neoplasm Metastasis | Adjuvant therapy allowed
Item
2. have received prior therapy for metastatic cancer. prior adjuvant therapy is allowed.
boolean
C1514463 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Tissue specimen Inadequate Biopsy
Item
3. inadequate or unusable tissue as the only tissue available for biopsy.
boolean
C1292533 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Medical contraindication First line Chemotherapy Regimen Component
Item
4. contraindication to any of the components of the the first-line chemotherapy regimen.
boolean
C1301624 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
Metastatic malignant neoplasm to brain | Meningeal disorder
Item
5. known brain metastases or meningeal disease.
boolean
C0220650 (UMLS CUI [1])
C0154728 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
6. female patients who are pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cancer treatment Other | Palliative Radiation Therapy allowed
Item
7. concurrent treatment with other anti-cancer therapy (palliative radiation is allowed but patients must have a metastatic site available for re-biopsy that has not been irradiated).
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3898008 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Abnormal coagulation profile | Anticoagulant therapy
Item
8. abnormal coagulation profile, any anti-coagulant therapy.
boolean
C0375576 (UMLS CUI [1])
C0150457 (UMLS CUI [2])
HIV Infection
Item
9. known infection with hiv.
boolean
C0019693 (UMLS CUI [1])
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