ID

39338

Beschreibung

Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01087333

Link

https://clinicaltrials.gov/show/NCT01087333

Stichworte

Versionen (1)
  1. 22.12.19 22.12.19 -
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See clinicaltrials.gov

Hochgeladen am

22. Dezember 2019

DOI

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Eligibility Hairy Cell Leukemia (HCL) NCT01087333

Englisch

Eligibility Hairy Cell Leukemia (HCL) NCT01087333

1 Formulare  
Criteria
Beschreibung

Criteria

1. patients may have a diagnosis of hematologic malignancy, including hcl, cll, ctcl, atl, nhl, all, or solid tumor, including mesothelioma. these patients would not be excluded if they were in complete remission or thought to be cured of their malignancy.
Beschreibung

Hematologic Neoplasms | Hairy Cell Leukemia | Chronic Lymphocytic Leukemia | Lymphoma, T-Cell, Cutaneous | Adult T-Cell Lymphoma/Leukemia | Lymphoma, Non-Hodgkin | Acute lymphocytic leukemia | Solid Neoplasm | Mesothelioma | Patients In complete remission | Patients Cured

Datentyp

boolean

Alias
UMLS CUI [1]
C0376545
UMLS CUI [2]
C0023443
UMLS CUI [3]
C0023434
UMLS CUI [4]
C0079773
UMLS CUI [5]
C0023493
UMLS CUI [6]
C0024305
UMLS CUI [7]
C0023449
UMLS CUI [8]
C0280100
UMLS CUI [9]
C0025500
UMLS CUI [10,1]
C0030705
UMLS CUI [10,2]
C0677874
UMLS CUI [11,1]
C0030705
UMLS CUI [11,2]
C1880198
2. patients and normal volunteer donors must be at least 18 years of age and able to give informed consent.
Beschreibung

Patients | Donors | Age | Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2]
C0040288
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0021430
3. for patients undergoing leukopheresis for research purposes, the hematocrit must be at least 28% and the platelet count at least 50,000/mm(3).
Beschreibung

Leukapheresis Research Purpose | Hematocrit level | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023416
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C1285529
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0032181
4. inclusion of women and minorities-both men and women and members of all races and ethnic groups are eligible for this trial.
Beschreibung

Gender | Minorities | Racial group All | Ethnic group All

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0026192
UMLS CUI [3,1]
C0034510
UMLS CUI [3,2]
C0444868
UMLS CUI [4,1]
C0015031
UMLS CUI [4,2]
C0444868
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
desire of the patient or normal donor not to submit samples.
Beschreibung

Patients | Donors | Specimen Collection Unwilling

Datentyp

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2]
C0040288
UMLS CUI [3,1]
C0200345
UMLS CUI [3,2]
C0558080
exclusion criteria for normal donors:
Beschreibung

Exclusion Criteria Donors

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0040288
heart, lung, kidney disease, or bleeding disorders.
Beschreibung

Heart Diseases | Lung diseases | Kidney Diseases | Blood Coagulation Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0005779
diagnosis of cancer
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
hepatitis since age 11.
Beschreibung

Hepatitis Since Age

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019158
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0001779
pregnancy
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
history of hiv infection or aids
Beschreibung

HIV Infection | AIDS

Datentyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0001175
history of high-risk activities for exposure to the aids virus, including:
Beschreibung

High risk of Exposure to AIDS Virus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0001175
UMLS CUI [1,4]
C0042776
receipt of money or drugs in exchange for sex in the past 5 years.
Beschreibung

Sex Behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0036864
use of needles to take drugs, steroids, or anything not prescribed by a physician in the past 5 years
Beschreibung

Use of Needle Drug abuse | Use of Needle Taking steroids | Use of Needle Non-Prescription Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0027551
UMLS CUI [1,3]
C0013146
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0027551
UMLS CUI [2,3]
C2054177
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0027551
UMLS CUI [3,3]
C0013231
sexual contact in past 12 months with anyone having these high-risk activities or anyone whose status is unknown.
Beschreibung

Sex Behavior Persons High risk

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0036864
UMLS CUI [1,2]
C0027361
UMLS CUI [1,3]
C4319571
symptoms of aids or other infection in past 12 months including:
Beschreibung

Symptoms AIDS | Symptoms Communicable Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0001175
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C0009450
unexplained weight loss or night sweats
Beschreibung

Unexplained weight loss | Night sweats Unexplained

Datentyp

boolean

Alias
UMLS CUI [1]
C1828173
UMLS CUI [2,1]
C0028081
UMLS CUI [2,2]
C4288071
blue or purple spots in the mouth or skin
Beschreibung

Blue skin spot | Purple skin spot

Datentyp

boolean

Alias
UMLS CUI [1]
C2126244
UMLS CUI [2]
C2126246
white spots or unusual sores in the mouth
Beschreibung

Oral Ulcer

Datentyp

boolean

Alias
UMLS CUI [1]
C0149745
persistent cough or shortness of breath
Beschreibung

Persistent cough | Dyspnea

Datentyp

boolean

Alias
UMLS CUI [1]
C0562483
UMLS CUI [2]
C0013404
chronic diarrhea
Beschreibung

Chronic diarrhea

Datentyp

boolean

Alias
UMLS CUI [1]
C0401151
fever of more than 100.5 degrees f for more than 10 days
Beschreibung

Fever Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0449238
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Ähnliche Modelle

Eligibility Hairy Cell Leukemia (HCL) NCT01087333

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Hematologic Neoplasms | Hairy Cell Leukemia | Chronic Lymphocytic Leukemia | Lymphoma, T-Cell, Cutaneous | Adult T-Cell Lymphoma/Leukemia | Lymphoma, Non-Hodgkin | Acute lymphocytic leukemia | Solid Neoplasm | Mesothelioma | Patients In complete remission | Patients Cured
Item
1. patients may have a diagnosis of hematologic malignancy, including hcl, cll, ctcl, atl, nhl, all, or solid tumor, including mesothelioma. these patients would not be excluded if they were in complete remission or thought to be cured of their malignancy.
boolean
C0376545 (UMLS CUI [1])
C0023443 (UMLS CUI [2])
C0023434 (UMLS CUI [3])
C0079773 (UMLS CUI [4])
C0023493 (UMLS CUI [5])
C0024305 (UMLS CUI [6])
C0023449 (UMLS CUI [7])
C0280100 (UMLS CUI [8])
C0025500 (UMLS CUI [9])
C0030705 (UMLS CUI [10,1])
C0677874 (UMLS CUI [10,2])
C0030705 (UMLS CUI [11,1])
C1880198 (UMLS CUI [11,2])
Patients | Donors | Age | Informed Consent
Item
2. patients and normal volunteer donors must be at least 18 years of age and able to give informed consent.
boolean
C0030705 (UMLS CUI [1])
C0040288 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
Leukapheresis Research Purpose | Hematocrit level | Platelet Count measurement
Item
3. for patients undergoing leukopheresis for research purposes, the hematocrit must be at least 28% and the platelet count at least 50,000/mm(3).
boolean
C0023416 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1285529 (UMLS CUI [1,3])
C0518014 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Gender | Minorities | Racial group All | Ethnic group All
Item
4. inclusion of women and minorities-both men and women and members of all races and ethnic groups are eligible for this trial.
boolean
C0079399 (UMLS CUI [1])
C0026192 (UMLS CUI [2])
C0034510 (UMLS CUI [3,1])
C0444868 (UMLS CUI [3,2])
C0015031 (UMLS CUI [4,1])
C0444868 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Patients | Donors | Specimen Collection Unwilling
Item
desire of the patient or normal donor not to submit samples.
boolean
C0030705 (UMLS CUI [1])
C0040288 (UMLS CUI [2])
C0200345 (UMLS CUI [3,1])
C0558080 (UMLS CUI [3,2])
Exclusion Criteria Donors
Item
exclusion criteria for normal donors:
boolean
C0680251 (UMLS CUI [1,1])
C0040288 (UMLS CUI [1,2])
Heart Diseases | Lung diseases | Kidney Diseases | Blood Coagulation Disorders
Item
heart, lung, kidney disease, or bleeding disorders.
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
Malignant Neoplasms
Item
diagnosis of cancer
boolean
C0006826 (UMLS CUI [1])
Hepatitis Since Age
Item
hepatitis since age 11.
boolean
C0019158 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
HIV Infection | AIDS
Item
history of hiv infection or aids
boolean
C0019693 (UMLS CUI [1])
C0001175 (UMLS CUI [2])
High risk of Exposure to AIDS Virus
Item
history of high-risk activities for exposure to the aids virus, including:
boolean
C0332167 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0001175 (UMLS CUI [1,3])
C0042776 (UMLS CUI [1,4])
Sex Behavior
Item
receipt of money or drugs in exchange for sex in the past 5 years.
boolean
C0036864 (UMLS CUI [1])
Use of Needle Drug abuse | Use of Needle Taking steroids | Use of Needle Non-Prescription Drugs
Item
use of needles to take drugs, steroids, or anything not prescribed by a physician in the past 5 years
boolean
C1524063 (UMLS CUI [1,1])
C0027551 (UMLS CUI [1,2])
C0013146 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0027551 (UMLS CUI [2,2])
C2054177 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0027551 (UMLS CUI [3,2])
C0013231 (UMLS CUI [3,3])
Sex Behavior Persons High risk
Item
sexual contact in past 12 months with anyone having these high-risk activities or anyone whose status is unknown.
boolean
C0036864 (UMLS CUI [1,1])
C0027361 (UMLS CUI [1,2])
C4319571 (UMLS CUI [1,3])
Symptoms AIDS | Symptoms Communicable Disease
Item
symptoms of aids or other infection in past 12 months including:
boolean
C1457887 (UMLS CUI [1,1])
C0001175 (UMLS CUI [1,2])
C1457887 (UMLS CUI [2,1])
C0009450 (UMLS CUI [2,2])
Unexplained weight loss | Night sweats Unexplained
Item
unexplained weight loss or night sweats
boolean
C1828173 (UMLS CUI [1])
C0028081 (UMLS CUI [2,1])
C4288071 (UMLS CUI [2,2])
Blue skin spot | Purple skin spot
Item
blue or purple spots in the mouth or skin
boolean
C2126244 (UMLS CUI [1])
C2126246 (UMLS CUI [2])
Oral Ulcer
Item
white spots or unusual sores in the mouth
boolean
C0149745 (UMLS CUI [1])
Persistent cough | Dyspnea
Item
persistent cough or shortness of breath
boolean
C0562483 (UMLS CUI [1])
C0013404 (UMLS CUI [2])
Chronic diarrhea
Item
chronic diarrhea
boolean
C0401151 (UMLS CUI [1])
Fever Duration
Item
fever of more than 100.5 degrees f for more than 10 days
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
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