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

Clinical trial: Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying bone marrow samples 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 samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To compare the frequency of germline telomerase mutations in pediatric patients with acute myeloid leukemia (AML) demonstrating prolonged myelosuppression, defined as ≥ 1 episode > 35 days of neutrophil count recovery after chemotherapy, to the pediatric patients with the expected myelosuppression, defined as consistently < 35 days of neutrophil count recovery after chemotherapy.
  -  To assess association between telomerase mutations and incidence of grade 3 or 4 mucositis, relapse, and death.
  -  To compare germline (remission) telomere length in pediatric AML patients demonstrating delayed bone marrow recovery with the pediatric patients with consistently expected recovery.
  -  To assess whether a correlation between telomere length and incidence of grade 3 or 4 mucositis, relapse, and death exist.
  OUTLINE: This is a multicenter study.
  Cryopreserved bone marrow samples are analyzed for DNA sequencing and mutation by Sanger-based sequencing methods, quantitative PCR, and SeqMan Pro (Lasergene from DNAStar). Results are then compared with previously published data and existing databases to determine the allele frequency in control populations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Enrolled on CCG-2961 and meeting 1 of the following criteria:
  -  More than 35 days to recover to an ANC > 500/mm³ after any course of chemotherapy
  -  Consistently recovered < 35 days to an ANC > 500/mm³ after all courses of chemotherapy
  -  Available cryopreserved cell from diagnostic and end-of-therapy samples
  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: Biomarkers in Bone Marrow Samples From Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of 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.
  PURPOSE: This laboratory study is studying bone marrow samples from patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  -  To rigorously examine fractionated hematopoietic stem and progenitor cells from patients with acute myeloid leukemia (AML).
  -  To define somatic mutations occurring in de novo AML, including the FLT3-ITD, CEBPA, NPM1, TET2, ASXL1, IDH1, and IDH2 mutations.
  -  To examine what cellular compartments (LT-HSC, ST-HSC, CMP, GMP, and MEP) contain the selected mutations and in what order those mutations occur.
  OUTLINE: Archived bone marrow specimens are analyzed for sequencing and detection of mutations by Sanger-based resequencing of PCR amplicons. Results are then compared with the results of age-matched healthy controls.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia
  -  Bone marrow samples must meet 1 of the following criteria:
  -  Normal karyotype from patients enrolled on ECOG-1900 archived at the ECOG Leukemia Tissue Bank
  -  Live, sortable mononuclear cells prepared at the time of initial diagnosis (slow-frozen in media with 10% DMSO OR fresh cells shipped immediately
  -  Age-matched healthy control samples from commercial providers
  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: Biomarker Study in Bone Marrow Samples From Patients With T-Cell Acute Lymphoblastic Leukemia

Summary: RATIONALE: Studying samples of 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 patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in bone marrow samples from patients with T-cell acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:
  -  To confirm an association between induction failure (IF) status predicted by a previously identified 116-member genomic classifier and actual induction therapy outcome observed on COG study AALL0434.
  -  To explore whether there is an association between early relapse (as defined by bone marrow or extramedullary relapse within 18 months of diagnosis) predicted by previously identified 5-member (primary) and 57-member (secondary) genomic classifiers, and actual relapse status at 18 months on COG study AALL0434. (Exploratory)
  OUTLINE: RNA from cryopreserved bone marrow samples are analyzed for gene expression by microarray methods. Samples are then compared with the 116-member genomic classifier.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed T-cell acute lymphoblastic leukemia
  -  Cryopreserved bone marrow from the Children Oncology Group (COG) Cell Bank of patients enrolled on COG-AALL03B1 and COG-AALL0434, including the following:
  -  30 samples from patients who had > 25% bone marrow blasts at day 29 (induction failure [IF] cases)
  -  Samples of cases of bone marrow and/or CNS relapse occurring within the first 18 months of treatment
  -  Random samples of 105 non-IF cases who achieved remission at the end of induction therapy (at least 18 months)
  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: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Summary: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Detailed description: Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Eligibility: Inclusion Criteria:
  -  Patients with diagnosed Acute Lymphocytic Leukemia
  Exclusion Criteria:
  -  Patients with diagnosis other than Acute Lymphocytic Leukemia

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

Clinical trial: Parent Training for Attention Deficit Hyperactivity Disorder (ADHD) Preschoolers

Summary: The purpose of this research is to evaluate and compare the effectiveness of two parenting programs in reducing the ADHD symptoms and behavioral problems of preschool children with ADHD through a controlled study. One program is a home-based parent training intervention that is designed to enhance the parent-child interaction, constructive parenting skills, and the child's tolerance for delay. The other intervention is a clinic-based parent training program that focuses on reducing noncompliance in preschool children and improving parenting skills.
  Both programs consist of private weekly parenting sessions with Clinical Psychologists - once a week for 8 weeks. The sessions are 1-1.5 hours in length. Both programs use behavior modification as a means of improving oppositional and non-compliant child behavior. Both interventions also involve procedures that focus on improving children's attention.
  Neither program involves medication, and all families will receive one of the two parenting programs being evaluated. Study evaluations, as well as participation in the parenting programs, are provided at no cost to families. Evaluation and parenting sessions can be scheduled at times convenient to families.


Eligibility: Inclusion Criteria:
  -  Age = 3.0 - 4.11
  -  In preschool program at least 2 half days per week
  -  Meets criteria for ADHD on clinical evaluation / DISC
  -  ADHD severity: > 1.5 SD above mean for age/sex on CTRS-R
  -  ADHD severity: > 1.0 SD above mean for age/sex on CPRS-R
  Exclusion Criteria:
  -  Current Medication treatment for ADHD
  -  IQ < 70 (Full Scale on WPPSI III)
  -  Pervasive Developmental Disorder
  -  Psychosis
  -  Severe receptive language impairment
  -  Neurological Disorder
  -  Significant medical disorder
  -  Primary caretaker is not able to participate
  -  Non-English speaking primary care taker

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

Clinical trial: Biomarkers in Predicting Response to Treatment in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research trial is studying biomarkers in predicting response to treatment in bone marrow samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  Primary
  -  To validate the accuracy of a pre-specified acute myeloid leukemia (AML) induction response classifier or the My Profile™ AML Induction Therapy Assay (run in a Good Laboratory Practice [GLP] laboratory using Good Manufacturing Practice [GMP] reagents) in predicting response to cytarabine-based induction chemotherapy in pediatric patients with non-M3 AML.
  Secondary
  -  To validate the continuous score from the pre-specified induction response classifier as a predictor of response to induction chemotherapy, after controlling for the simultaneous effects of clinical variables at base-line and/or pre-induction therapy (e.g., age, WBC, and percentage [%] of blasts), and tests commonly available after the start of induction therapy (e.g., cytogenetics and molecular markers).
  -  To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to no response (NR) or complete response (CR) groups.
  -  To validate the accuracy of the pre-specified induction response classifier as a binary predictor of induction response using a pre-specified cutpoint to assign patients to NR or CR groups, after controlling for the simultaneous effects of clinical variables at base-line (pre-induction therapy) (e.g., age, WBC, % blasts) and clinical variables, including tests commonly available after start of induction therapy (e.g., age, WBC, cytogenetics).
  OUTLINE: Cryopreserved bone marrow mononuclear cell specimens are analyzed by cell networking profiling assays. Results are then compared with patient outcomes and demographics from COG-AAML03P1 and COG-AAML0531 studies.
  Molecular markers analyzed include Flt3ITD, NPM1, CEBPA, and MRA.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia (AML)
  -  Non-M3 AML
  -  Cryopreserved bone marrow mononuclear cell specimens from patients enrolled on COG-AAML03P1 and COG-AAML0531 collected prior to cytarabine-based induction therapy
  -  Patient samples from COG-AAML0531 must come from the control arm (i.e., no gemtuzumab ozogamicin induction therapy)
  PATIENT CHARACTERISTICS:
  -  No Down syndrome
  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: A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Summary: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Detailed description: Principal Investigators:
  The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.
  Study Design:
  This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
  Primary Objective:
  The primary objective of this study is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.
  Secondary Objectives:
  In patients receiving a non-licensed CBU:
  -  Assess incidence of transmission of infection
  -  Assess incidence of serious infusion reaction
  -  Determine 1 year overall survival after cord blood transplantation
  -  Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  -  Assess cumulative incidence of chronic GVHD
  -  Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Eligibility: Inclusion Criteria:
  -  Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  -  Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  -  Pediatric and adult patients of any age
  Exclusion Criteria:
  -  Patients who are receiving only licensed CBUs
  -  Cord blood transplant recipients at international transplant centers
  -  Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
  -  Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

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

Clinical trial: Utility of XCL1 as a Prognostic Marker in Acute Lymphoblastic Leukemia

Summary: The purpose of the study is to determine the utility of XCL1 in the prognosis of acute lymphoblastic leukemia.

Detailed description: Each year approximately 256,000 children and adults around the world develop a form of leukemia, and 209,000 died from it. Recently, some studies have evaluated the relationship between the concentration of some cytokines and prognosis of acute lymphoblastic leukemia. XCL1 is a lymphotactin that belongs to a cytokine subfamily called C or γ with only one cysteine in the N-terminal residue. It has been found with significant expression of receptor mRNA XCL1 (XCR1) in T and B lymphocytes and related to hematological neoplasms. For these reasons, XCL1 could be a efficient marker of prognosis in patients with acute lymphoblastic leukemia.

Eligibility: Inclusion Criteria:
  Patients with newly diagnosed acute lymphoblastic leukemia .
  Exclusion Criteria:
  -  Patients with prior treatment with chemotherapeutic agents.
  -  Patients treated with immunosuppressants.
  -  Patients under 12 months old.
  -  Patients with a diagnosis or history of autoimmune diseases.
  -  Patients with a diagnosis or history of immunosuppressive diseases.
  -  Patients who do not agree to sign a Letter of Informed Consent.

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

Clinical trial: Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children

Summary: Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
  Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity


Eligibility: Inclusion Criteria:
  -  presence of > 25% of blast in bone marrow
  -  treatment with second line therapies
  -  patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration
  -  children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
  -  Relapsed after > months after SCT
  -  Karnofsky score >50
  -  a Forced Espiratory Volume >30%
  -  sufficient hepatic and renal function defined as creatinine levels <2 × ULN, bilirubin <1.5 × ULN
  -  aspartate and alanine aminotransferases <10 × ULN.
  Exclusion Criteria:
  -  isolated extra-medullary relapse, and active infections

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

Clinical trial: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

Summary: The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.


Eligibility: Inclusion Criteria:
  -  child is enrolled in Head Start
  Exclusion Criteria:
  -  Significant developmental disabilities that would preclude participation
  -  Child is a foster child
  -  Parent is non-English speaking

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

Clinical trial: Study of Gemtuzumab Ozogamicin Therapy in DNA Samples From Patients With Acute Myeloid Leukemia Treated on COG-AAML0531

Summary: RATIONALE: DNA analysis of blood and tissue samples may help doctors predict how well patients will respond to treatment. It may also help doctors learn more about how gemtuzumab ozogamicin works in the body.
  PURPOSE: This research study is looking at gemtuzumab ozogamicin in DNA samples from patients with acute myeloid leukemia treated on COG-AAML0531.

Detailed description: OBJECTIVES:
  -  To genotype the genomic DNA from acute myeloid leukemia (AML) patients treated on COG-AAML0531 clinical trial for CD33 (and PgP and SOC3) single nucleotide polymorphisms (SNPs).
  OUTLINE: Archived DNA samples are analyzed for single nucleotide polymorphisms in CD33, PgP, and SOC3 genes by Sequenome platform. Results are then compared with patients clinical outcomes, including minimal-residual disease levels post induction I (chemotherapy and gemtuzumab ozogamicin), complete remission rates, refractory disease with various levels of bone marrow blasts, development of CNS/persistent disease, event-free survival, overall survival, and toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosed with acute myeloid leukemia
  -  DNA samples from patients treated on COG-AAML0531
  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 to Predict Risk of Relapse in Bone Marrow Cell Samples From Younger Patients With Acute Myeloid Leukemia

Summary: RATIONALE: A screening test, such as My Profile Pediatric Assay, may help doctors predict a patient's risk of relapse and plan better treatment for acute myeloid leukemia.
  PURPOSE: This clinical trial is studying using the My Profile Pediatric Assay to see how well it works in predicting risk of relapse in bone marrow cell samples from younger patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  Primary
  -  To validate the accuracy of the My Profile Pediatric Assay to predict risk of relapse in pediatric patients with non-M3 acute myeloid leukemia (AML) who responded to cytarabine-based induction chemotherapy.
  Secondary
  -  To validate the continuous score from the pre-specified classifier as a predictor of relapse after response to induction chemotherapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, MRD, and bone marrow (BM) donor availability.
  -  To validate the accuracy of the prespecified low versus high relapse indicator variable (I_L/H) as a predictor of relapse after induction therapy.
  -  To validate the accuracy of the prespecified I_L/H as a predictor of relapse after induction therapy, while controlling for the simultaneous effects of the following clinical and laboratory variables: MRD, age, WBC, ethnicity, cytogenetics, Flt3-ITD, NPM1, and BM donor availability.
  OUTLINE: Archived bone marrow mononuclear cells are analyzed by single cell network profile assay, the My Profile™ AML Risk of Relapse Assay. Molecular markers analyzed include Flt3-ITD, NPM1, and MRA. Results are then correlated with each patient's clinical data including patient's age, race/ethnic background, gender, treatment received, and outcomes.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients with confirmed non-M3 acute myeloid leukemia
  -  Treated on COG-AAML03P1 or COG- AAML0531 protocols
  -  Samples from COG-AAML0531 can come from either treatment arm, but these samples need to be independent from any patients who donated samples assayed in study COG-AAML11B2
  -  Patients with Down syndrome are excluded
  -  Cryopreserved bone marrow mononuclear cell (BMMC) samples collected at diagnosis, prior to start induction therapy
  -  Samples must have been cryopreserved at central lab within 3 days of draw at clinical site
  -  Target of 10 X 10^6 cells frozen
  -  Patients' clinical annotations required after unblinding
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant