Informações:
Falhas:
ID
45392
Descrição
Principal Investigator: Richard Weinshilboum, MD, Mayo Clinic MeSH: Leukemia, Lymphoid https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000621 The ECOG 2997 trial was a randomized controlled trial for patients with previously untreated CLL comparing fludarabine monotherapy to the combination of fludarabine and cyclophosphamide. The initial clinical findings of this study were published in the Journal of Clinical Oncology in 2007 (JCO 25:793-8). Additional laboratory studies have also published (JCO 25:799-804).
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- 15/11/2022 15/11/2022 - Simon Heim
Titular dos direitos
Richard Weinshilboum, MD, Mayo Clinic
Transferido a
15 de novembro de 2022
DOI
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Licença
Creative Commons BY 4.0
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dbGaP phs000621 Genome Wide Association Studies in ECOG 2997 Trial
Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- Subject ID, consent group, subject source, subject source ID, and affection status of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Subject ID, sample ID, plate for genotype, well within plate, sample source, sample source ID, and sample use variable of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Subject ID, age, sex, best confirmed response for treatment, progression-free survival censor, progression-free survival time, survival censor variable, toxicity due to grade 4 neutropenia, total number of treatment cycles, and rice of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Sample ID, body site where sample was obtained, analyte type, tumor status, histological type of sample, primary metastatic tumor, primary tumor location, tumor stage, tumor grade, treatment of tumors obtained from participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
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Eligibility Criteria
- StudyEvent: SEV1
- Eligibility Criteria
- Subject ID, consent group, subject source, subject source ID, and affection status of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Subject ID, sample ID, plate for genotype, well within plate, sample source, sample source ID, and sample use variable of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Subject ID, age, sex, best confirmed response for treatment, progression-free survival censor, progression-free survival time, survival censor variable, toxicity due to grade 4 neutropenia, total number of treatment cycles, and rice of participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
- Sample ID, body site where sample was obtained, analyte type, tumor status, histological type of sample, primary metastatic tumor, primary tumor location, tumor stage, tumor grade, treatment of tumors obtained from participants with untreated chronic lymphocytic leukemia and involved in the "Genome Wide Association Studies in ECOG 2997 Trial" project.
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
DISEASE CHARACTERISTICS:
Item
DISEASE CHARACTERISTICS:
boolean
C0012634 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1521970 (UMLS CUI [1,2])
Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
Item
Diagnosis of chronic lymphocytic leukemia (CLL) of any stage as defined by the following:
boolean
C0011900 (UMLS CUI [1,1])
C0023434 (UMLS CUI [1,2])
C0023434 (UMLS CUI [1,2])
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
Item
Peripheral blood absolute lymphocyte count greater than 5,000/mm^3 within 14 days prior to study
boolean
C5401001 (UMLS CUI [1,1])
C3544087 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C5421123 (UMLS CUI [1,4])
C3544087 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C5421123 (UMLS CUI [1,4])
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
Item
Lymphocytes must be small to moderate size with no more than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
boolean
C1550651 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0229614 (UMLS CUI [1,4])
C0221277 (UMLS CUI [1,5])
C0229613 (UMLS CUI [1,6])
C0456389 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0229614 (UMLS CUI [1,4])
C0221277 (UMLS CUI [1,5])
C0229613 (UMLS CUI [1,6])
Phenotypically characterized as B-CLL
Item
Phenotypically characterized as B-CLL
boolean
C0031437 (UMLS CUI [1,1])
C1880022 (UMLS CUI [1,2])
C0861888 (UMLS CUI [1,3])
C1880022 (UMLS CUI [1,2])
C0861888 (UMLS CUI [1,3])
Must have one of the following characteristics indicating need for chemotherapy:
Item
Must have one of the following characteristics indicating need for chemotherapy:
boolean
C0599878 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C0686904 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
Item
Progressive marrow failure (hemoglobin less than 10 g/dL and/or platelet count less than 100,000/mm^3)
boolean
C4228360 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,3])
C0032181 (UMLS CUI [1,2])
C0518015 (UMLS CUI [1,3])
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
Item
Progressive lymphocytosis with an increase of more than 50% over a 2 month period or anticipated doubling time of less than 6 months
boolean
C0205329 (UMLS CUI [1,1])
C0024282 (UMLS CUI [1,2])
C0024282 (UMLS CUI [1,2])
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
Item
Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly
boolean
C0522501 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
C0038002 (UMLS CUI [1,3])
C1335499 (UMLS CUI [1,2])
C0038002 (UMLS CUI [1,3])
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
Item
Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy
boolean
C0522501 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1704332 (UMLS CUI [1,3])
C0497156 (UMLS CUI [1,4])
C1335499 (UMLS CUI [1,5])
C0024204 (UMLS CUI [1,2])
C1704332 (UMLS CUI [1,3])
C0497156 (UMLS CUI [1,4])
C1335499 (UMLS CUI [1,5])
At least 10% weight loss within 6 months of study
Item
At least 10% weight loss within 6 months of study
boolean
C1262477 (UMLS CUI [1,1])
C3828652 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,2])
Extreme fatigue
Item
Extreme fatigue
boolean
C0205403 (UMLS CUI [1,1])
C0015672 (UMLS CUI [1,2])
C0015672 (UMLS CUI [1,2])
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
Item
Fevers greater than 100.5 degrees F for 2 weeks without evidence of infection
boolean
C0015967 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1442457 (UMLS CUI [1,3])
C0332125 (UMLS CUI [1,4])
C3714514 (UMLS CUI [1,5])
C0449238 (UMLS CUI [1,2])
C1442457 (UMLS CUI [1,3])
C0332125 (UMLS CUI [1,4])
C3714514 (UMLS CUI [1,5])
Night sweats without evidence of infection
Item
Night sweats without evidence of infection
boolean
C0028081 (UMLS CUI [1,1])
C0332125 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
C0332125 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
No autoimmune anemia or autoimmune thrombocytopenia
Item
No autoimmune anemia or autoimmune thrombocytopenia
boolean
C1549444 (UMLS CUI [1,1])
C0002880 (UMLS CUI [1,2])
C0242584 (UMLS CUI [1,3])
C0002880 (UMLS CUI [1,2])
C0242584 (UMLS CUI [1,3])
PATIENT CHARACTERISTICS:
Item
PATIENT CHARACTERISTICS:
boolean
C0030705 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C1521970 (UMLS CUI [1,2])
Age:
Item
Age:
boolean
C0001779 (UMLS CUI [1,1])
18 and over
Item
18 and over
boolean
C0001779 (UMLS CUI [1,1])
Performance status:
Item
Performance status:
boolean
C1518965 (UMLS CUI [1,1])
ECOG 0-2
Item
ECOG 0-2
boolean
C1520224 (UMLS CUI [1,1])
Life expectancy:
Item
Life expectancy:
boolean
C0023671 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Hematopoietic:
Item
Hematopoietic:
boolean
C0229601 (UMLS CUI [1,1])
See Disease Characteristics
Item
See Disease Characteristics
boolean
C0599878 (UMLS CUI [1,1])
Hepatic:
Item
Hepatic:
boolean
C0205054 (UMLS CUI [1,1])
Bilirubin no greater than 2 mg/dL unless secondary to tumor
Item
Bilirubin no greater than 2 mg/dL unless secondary to tumor
boolean
C0201913 (UMLS CUI [1,1])
Renal:
Item
Renal:
boolean
C0232804 (UMLS CUI [1,1])
Creatinine no greater than 2.0 mg/dL
Item
Creatinine no greater than 2.0 mg/dL
boolean
C0201976 (UMLS CUI [1,1])
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL
Item
Creatinine clearance at least 40 mL/min if creatinine is greater than 1.5 mg/dL
boolean
C0373595 (UMLS CUI [1,1])
Other:
Item
Other:
boolean
C0205394 (UMLS CUI [1,1])
No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
Item
No other prior or concurrent malignancy within the past 2 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix
boolean
C1298908 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0007117 (UMLS CUI [1,6])
C0851140 (UMLS CUI [1,7])
C0332152 (UMLS CUI [1,2])
C0205420 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0332300 (UMLS CUI [1,5])
C0007117 (UMLS CUI [1,6])
C0851140 (UMLS CUI [1,7])
No active infection requiring oral or intravenous antibiotics
Item
No active infection requiring oral or intravenous antibiotics
boolean
C1298908 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,5])
C0442027 (UMLS CUI [1,6])
C0348016 (UMLS CUI [1,7])
C0205177 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
C1514873 (UMLS CUI [1,4])
C0003232 (UMLS CUI [1,5])
C0442027 (UMLS CUI [1,6])
C0348016 (UMLS CUI [1,7])
Not pregnant or nursing
Item
Not pregnant or nursing
boolean
C1272460 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
C0032961 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,3])
Fertile patients must use effective contraception
Item
Fertile patients must use effective contraception
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,2])
PRIOR CONCURRENT THERAPY:
Item
PRIOR CONCURRENT THERAPY:
boolean
C1514463 (UMLS CUI [1,1])
Biologic therapy:
Item
Biologic therapy:
boolean
C0005527 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Chemotherapy:
Item
Chemotherapy:
boolean
C0392920 (UMLS CUI [1,1])
No prior cytotoxic chemotherapy
Item
No prior cytotoxic chemotherapy
boolean
C1298908 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0677881 (UMLS CUI [1,3])
C1514457 (UMLS CUI [1,2])
C0677881 (UMLS CUI [1,3])
Endocrine therapy:
Item
Endocrine therapy:
boolean
C0279025 (UMLS CUI [1,1])
No prior steroid treatment for CLL
Item
No prior steroid treatment for CLL
boolean
C1298908 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
C1514463 (UMLS CUI [1,2])
C0149783 (UMLS CUI [1,3])
C0023434 (UMLS CUI [1,4])
Radiotherapy:
Item
Radiotherapy:
boolean
C1522449 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])
Surgery:
Item
Surgery:
boolean
C0543467 (UMLS CUI [1,1])
Not specified
Item
Not specified
boolean
C0205370 (UMLS CUI [1,1])