araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone

Summary: RATIONALE: Gathering information about how often methemoglobinemia occurs in young patients receiving dapsone for hematologic cancer or aplastic anemia may help doctors learn more about the disease and plan the best treatment.
  PURPOSE: This research study is looking at methemoglobinemia in young patients with hematologic cancer or aplastic anemia treated with dapsone.

Detailed description: OBJECTIVES:
  -  Define the incidence of methemoglobinemia in patients with hematologic malignancy or aplastic anemia who received dapsone prophylaxis through a retrospective chart review encompassing the last 15 years.
  -  Identify major risk factors for developing methemoglobinemia.
  OUTLINE: Medical charts are reviewed. Of particular interest is demographic information, reasons for beginning dapsone prophylaxis, duration of dapsone prophylaxis, dapsone dosing, methemoglobin level, and treatment with methylene blue.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of hematologic malignancy or aplastic anemia
  -  Treated within the past 15 years with dapsone prophylaxis during treatment of primary disease
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: S9007, Study of Bone Marrow and Blood Samples From Patients With Leukemia or Other Hematopoietic Cancers

Summary: RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at bone marrow and blood samples from patients with leukemia or other hematopoietic cancers.

Detailed description: Primary objective:
  * Maintain and expand a database of cytogenetic information on leukemia patients.
  Other objectives as funding permits:
  -  Determine the frequency and prognostic significance of cytogenetic abnormalities in bone marrow or peripheral blood cells in patients with leukemia prior to treatment and at various times during treatment undergoing treatment on a companion clinical trial.
  -  Correlate the presence of cytogenetic features with clinical, pathophysiological, cellular, and molecular characteristics in these patients.
  -  Provide quality control for all Southwest Oncology Group cytogenetic data.
  OUTLINE: Bone marrow and/or peripheral blood samples from patients on specific treatment protocols for leukemia are analyzed for cytogenetic abnormalities. Samples from patients with chronic lymphocytic leukemia (CLL) are analyzed for trisomy 12 by fluorescence in situ hybridization and conventional cytogenetics.
  PROJECTED ACCRUAL: Approximately 2,500 patients (1,200 with first-line acute myeloid leukemia [AML], 500 with first-line acute lymphoblastic leukemia [ALL], 200 with relapsed AML, 125 with chronic phase chronic myelogenous leukemia [CML], 100 with accelerated phase or blastic phase CML, 250 with hairy cell leukemia, and 125 with relapsed ALL or CLL) will be accrued for this study within 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Registered on one of the following Southwest Oncology Group treatment protocols:
  -  SWOG-8326, SWOG-8600, SWOG-8612, SWOG-9034, SWOG-9108, OR any new leukemia protocol approved as of 1990
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Study of Biomarkers in Blood and Bone Marrow Samples From Patients With Previously Untreated Chronic Lymphocytic Leukemia

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This research study is looking at biomarkers in blood and bone marrow samples from patients with previously untreated chronic lymphocytic leukemia.

Detailed description: OBJECTIVES:
  -  Determine the relevance of common and uncommon interphase cytogenetic abnormalities related to baseline clinical features, complete response (CR), prolonged progression-free survival (PFS), and overall survival (OS) in patients with previously untreated chronic lymphocytic leukemia.
  -  Determine the significance of the absence of IgV_H gene mutational status as related to the ability to predict CR, PFS, and OS in these patients.
  -  Correlate IgV_H gene mutational status with CD38 expression, ZAP-70 expression, over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, high-risk karyotype abnormalities, and other molecular features associated with poor outcome in these patients.
  -  Determine the prognostic significance of over-expression of Mcl-1, BAK-1, high Mcl-1:Bax ratio, p53 mutations or dysfunction, ATM mutation, ATM expression, and other factors that disrupt apoptosis with respect to CR, prolonged PFS, and OS.
  -  Determine if clonal evolution occurs in these biological markers at partial response or disease relapse.
  OUTLINE: This is a multicenter study.
  Blood and bone marrow is collected at baseline, 3 months after completion of induction therapy, 2 months after completion of consolidation therapy, 1 year after completion of study treatment, and at disease relapse. Samples are analyzed by FISH for interphase cytogenetics, PCR for IgV_H mutational status, flow cytometry for surface expression of CD38 cells, western blot to assess Mcl-1, Bcl-2, BAK-1, ATM, ZAP-70, and Bar expression, and sequencing for p53 and ATM function.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of chronic lymphocytic leukemia
  -  Previously untreated disease
  -  Registered to receive treatment on a Cancer and Leukemia Group B protocol
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

Summary: RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:
  -  To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
  -  To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
  -  To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
  -  To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.
  OUTLINE: This is a multicenter study.
  DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.
  Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute lymphoblastic leukemia (ALL)
  -  Previously enrolled in COG-9900, COG-C1991, COG-AALL03B1, COG-AALL05B1, COG-AALL08P1, or other current COG or legacy trials for ALL AND consented to submit blood and marrow samples for biological research studies
  -  Meets ≥ 1 of the following criteria:
  -  Germline DNA that has been extracted from blood (preferentially) or bone marrow (if no appropriate blood available) that was collected on or after Day 28 of remission indication therapy, or is known to come from a sample that contained < 10% leukemic blasts
  -  ALL blast DNA that has been extracted from bone marrow (preferentially) or blood (if from a sample that contained > 90% leukemic blasts and no diagnostic bone marrow is available) that was collected at the time of ALL diagnosis
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Impact of Helmet Use in Preschool Children

Summary: -  To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
  -  To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Detailed description: Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.
  The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Eligibility: Inclusion Criteria:
  -  Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
  -  The child must possess a bicycle or a riding toy to ride
  -  The child's caregiver speaks English or Spanish
  Exclusion Criteria:
  -  Age less than two or greater than 5-year olds
  -  3-5 year old children that do not own a bicycle or a riding toy to ride
  -  The child's caregiver does not speak English or Spanish.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Summary: This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.


Eligibility: Inclusion Criteria:
  -  Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
  -  adequate renal, hepatic and pancreatic function
  Exclusion Criteria:
  -  patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
  -  patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
  -  gastrointestinal impairment or disease that may interfere with drug absorption
  -  liver, pancreatic or severe renal disease unrelated to disease under study
  -  impaired cardiac function
  -  patients who received dasatinib within 3 days of starting study drug
  -  patients who received imatinib within 5 days of starting study drug
  -  patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
  -  patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
  -  patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and < 3 months since SCT
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Genome, Proteome and Tissue Microarray in Childhood Acute Leukemia

Summary: We will study gene and protein expression in leukemia cells of children diagnosed with acute leukemia. We hope to identify genes or proteins which can help us grade leukemia at diagnosis in order to: (a) develop better means of diagnosis and (b) more accurately choose the best therapy for each patient.


Eligibility: Inclusion Criteria:1. All children who present at Packard hospital with a new diagnosis or relapse of acute leukemia will be eligible. There is no bias in regards to age range, gender or ethnic background.
  2. Signed informed consent

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia

Summary: RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:
  -  To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols.
  -  To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients.
  -  To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform.
  -  To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation.
  OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia
  -  Matched patients non-tumor and blast DNA samples
  -  Enrolled on COG-P9906 or COG-AALL0232 protocols
  -  Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri
  PATIENT CHARACTERISTICS:
  -  Newborn infants from the state of Missouri
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Biomarkers in Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
  -  Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.
  OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  One of the following karyotypes:
  -  t(8;21) and WT c-kit
  -  t(8;21) and mutant c-kit
  -  Normal karyotype
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Pharmacokinetic Profile of Vincristine Administered With Imatinib for Bcr-Abl Positive Acute Lymphoblastic Leukemia (ALL) Compared to That Without Imatinib for Bcr-Abl Negative ALL

Summary: This study is characterizing the pharmacokinetics of vincristine using two different cohorts of patients. The first cohort includes patients with acute lymphoblastic leukemia (ALL) that are Bcr-Abl positive. This cohort of patients will receive vincristine along with imatinib in the induction chemotherapy regimen. The second cohort includes patients with ALL that are Bcr-Abl negative. This cohort of patients will receive vincristine without imatinib in the induction chemotherapy regimen. This study involves blood draws beginning on day 7 of the treatment protocol and these samples will be analyzed for pharmacokinetic parameters.
  Imatinib and vincristine are both metabolized by the hepatic CYP 450 enzyme system. Imatinib is an inhibitor of the system and co-administration of imatinib and vincristine has the potential to increase the blood level of vincristine. This could explain the increased level of neurotoxicity that is currently being seen with the co-administration of these two agents in the treatment of Bcr-Abl positive ALL.


Eligibility: Inclusion Criteria:
  -  Age >/= 18 years
  -  New Diagnosis of Bcr-Abl positive ALL or Bcr-Abl negative ALL
  -  Receiving induction chemotherapy with the standard Princess Margaret Hospital modified DFCI protocol
  -  Will have a functioning central venous access catheter in-situ
  -  Agreeing to participate in the study and sign the informed consent form
  Exclusion Criteria:
  -  Concomitant use of other agents that inhibit hepatic cytochrome CYP3A4, as these drugs may alter vincristine and imatinib levels
  -  Elevated liver function tests: bilirubin >1.5xULN or AST/ALT >2.5xULN, or documented history of chronic liver disease.

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children

Summary: The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.


Eligibility: Inclusion Criteria:
  1. children with nasal discharge (of any quality) or daytime cough (which may be worse at night) or both persisting for 10 days or more without evidence of improvement.
  2. families need to be English speaking
  Exclusion Criteria:
  1. used antibiotics within the last 15 days;
  2. had symptoms for > 30 days;
  3. have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days);
  4. are allergic to penicillin;
  5. have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation
  6. been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract
  7. history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year)
  8. history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season)
  9. girls who have begun menstruating

Relevance to patient case: not relevant
Patient case: 4-year-old female with leukemia; genetic feature: ABL1

Clinical trial: Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV

Summary: This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or HIV will be vaccinated twice with one of the two vaccines and evaluated for development of immune responses.

Detailed description: The primary objectives of this study are to compare the immune response of Fluzone HD, a high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children with cancer and in children with HIV.
  The secondary objectives of this study are to:
  -  Describe the safety and reactogenicity of high-dose and standard-dose TIV.
  -  Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and standard-dose TIV.
  -  Describe the relationship between baseline lymphocyte numbers/function and robustness/durability of the immune response.

Eligibility: Inclusion Criteria:
  -  Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached their 22nd birthday) at the time of entry into the study.
  -  Written informed consent (and assent, if applicable) obtained.
  -  Participant has a diagnosis of cancer or HIV.
  -  If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the treatment of cancer or has received chemotherapy in the past 12 weeks
  Exclusion Criteria
  -  Severe hypersensitivity to egg proteins or any component of Fluzone, or life-threatening reactions after any previous administration of any influenza vaccine;
  -  History of Guillain-Barre´ syndrome in the subject or subject's family (parents, siblings, half siblings, or children);
  -  Not willing to agree to acceptable birth control for three months after study immunization

Relevance to patient case: not relevant