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

Clinical trial: A Drug-Drug Interaction Study of ALKS 5461 in Healthy Volunteers

Summary: This study will evaluate the impact of Itraconazole on the pharmacokinetics of ALKS 5461.


Eligibility: Inclusion Criteria:
  -  Has a body mass index (BMI) of 18.0 - 30.0 kg/m2
  -  Is in good physical health
  -  Agrees to use an approved method of contraception for the duration of the study
  -  Additional criteria may apply
  Exclusion Criteria:
  -  Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality
  -  Is currently pregnant or breastfeeding
  -  Has a history of or current infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
  -  Has a lifetime history of opioid abuse or dependence
  -  Has current abuse or dependence on alcohol or any drugs
  -  Has used nicotine within 90 days prior to randomization
  -  Additional criteria may apply

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

Clinical trial: Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer

Summary: This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid [DNA]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment.
  II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer.
  III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing.
  OUTLINE:
  Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
  After completion of study, patients are followed up every 3 months for up to 3 years.

Eligibility: Inclusion Criteria:
  -  COHORT 1: LUNG CANCER PATIENTS
  -  Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer [SCLC] or non-small cell lung cancer [NSCLC] of any stage) at any treatment time point
  -  For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis
  -  For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation
  -  Provision of written informed consent
  -  Willingness to undergo a single blood draw
  -  Individuals who are under 18 are eligible for study if they meet the defined criteria for cohort 1; in addition, consent for participation must be given by a legal guardian or parent
  -  NOTE: to be eligible for genomics, availability of 10 unstained slides (plus hematoxylin and eosin [H&E] slide) or an adequate formalin-fixed paraffin-embedded (FFPE) tumor block from clinically indicated interventional procedures is required
  -  COHORT 2: DECEASED INDIVIDUALS
  -  Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied on a case by case basis depending upon Institutional Review Board (IRB) approval at a participating institution; inclusion will require availability of adequate archived FFPE tissue and release of tissue and records by next of kin, if available
  Exclusion Criteria:
  -  Compromise of patient diagnosis or staging if tissue is used for research

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

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

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

Clinical trial: Ceritinib Rare Indications Study in ALK+ Tumors

Summary: This is Proof-of-Concept (POC) study to assess the preliminary antitumor activity and safety and tolerablity using ceritinib (LDK378) in the treatment of life threatening tumors that are characterized by ALK genetic alteration (and/or overexpression in some diseases).


Eligibility: Inclusion Criteria:
  -  Patient has a histologically or cytologically confirmed diagnosis of ALK positive (ALK+) other than Non-Small Cell Lung Cancer (NSCLC).
  -  Patient must provide an archival or fresh tumor tissue before the first dose of the study drug for ALK testing at a Novartis designated central laboratory.
  -  Patient has WHO Performance Status (PS) ≤ 2
  -  Patient must have received at least one line of prior systemic treatment for recurrent, locally advanced and/or metastatic disease, may have discontinued for:
  -  Disease progression as defined by RECIST 1.1 for solid tumors; by RANO for GBM and by Cheson assessment criteria for lymphoma
  -  Intolerance described as any discontinuation due to an AE of any grade despite appropriate supportive treatment
  -  Patient has at least one measurable lesion as defined by appropriate guidelines. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation.
  Exclusion Criteria:
  -  Patient has ALK+lung cancer
  -  Patient with symptomatic CNS metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient with acute or chronic GI disease that may significantly alter the absorption of ceritinib.
  -  Patient with a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  -  Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis.
  -  Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months).
  -  Patient has evidence of active viral hepatitis, including Hepatitis A, B or C (testing for viral hepatitis is not mandatory).
  -  Patient has known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory).

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

Clinical trial: Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

Summary: This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

Detailed description: Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject to approval by the sponsor).
  -  Inability to swallow crizotinib capsules, adult patients of whom must either have a feeding tube in place or have completed clinical evaluation of dysphagia without any reversible causes identified.
  -  At least 12 months of age (patients <12 months of age will be evaluated on a case by case basis and discussed with the sponsor).
  Exclusion Criteria:
  -  Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
  -  Adult patients who have been previously treated with crizotinib.

Relevance to patient case: possibly relevant
Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib

Summary: The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.

Detailed description: ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.

Eligibility: Inclusion Criteria:
  -  primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
  -  ECOG 0-2
  -  more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
  -  estimated survival >/3months
  -  Age 18-65 years
  -  Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
  -  Signature of informed consent
  Exclusion Criteria:
  -  Age <\ 18years
  -  without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
  -  without measurable lesions
  -  being treated by other drugs in other clinical trials
  -  Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
  -  Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
  -  Renal insufficiency: more than 2 times higher than that of normal serum creatinine
  -  Blood screening period: WBC < 1 * 109/L * 109/L; platelet < 25; Hb < 60g/L
  -  HIV test positive

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

Clinical trial: A Water Consumption Study of ALKS 5461 in Healthy Volunteers

Summary: This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.


Eligibility: Inclusion Criteria:
  -  Has a body mass index (BMI) of 18.0 - 30.0 kg/m^2
  -  Is in good physical health
  -  Agrees to use an approved method of contraception for the duration of the study
  -  Additional criteria may apply
  Exclusion Criteria:
  -  Is currently pregnant or breastfeeding
  -  Has a history of substance abuse disorder
  -  Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
  -  Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
  -  Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
  -  Has used alcohol within 72 hours prior to any inpatient period
  -  Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
  -  Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
  -  Additional criteria may apply

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

Clinical trial: Genomic Landscape of Ceritinib

Summary: The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression.

Detailed description: Further improvements in therapy can only be achieved with a better understanding of the genomic landscape of ALK rearranged non-small cell lung cancer (NSCLC), specifically at the time of disease progression following treatment with ALK inhibitors. Recently, secondary ALK mutations, L1196M and G1269A have been described in patients with acquired resistance to crizotinib. A small subset of ALK positive lung cancer patients who progressed after treatment with ceritinib had tumors available for molecular analysis. Secondary mutations found included G1202R, F1174C, and F1174V. While this is interesting, an unbiased genomic study (exome or whole genome sequencing) using massively parallel sequencing at the time of disease progression is critical to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. To the best of the investigators' knowledge, such a study has not yet been reported.
  The investigators believe the time is ripe now to comprehensively characterize genomic alterations using massively parallel sequencing technology of ALK driven adenocarcinoma of the lung to fully understand the clonal heterogeneity before therapy and fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. A better understanding of genomic alterations through an unbiased comprehensive approach likely would lead to rationally designed therapy to augment response to ALK inhibitors.

Eligibility: Inclusion Criteria
  -  Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma.
  -  Presence of known ALK gene rearrangement.
  -  Consented to HRPO# 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma") with an existing specimen prior to initiation of treatment with ceritinib.
  -  At least 18 years of age.
  -  Received treatment with standard of care ceritinib

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

Clinical trial: Anti-angiogenetic Therapy With Radiotherapy for Pediatric Neuroblastoma

Summary: The purpose of this study is to evaluate the safety and efficacy of Radiotherapy plus Endostar(Recombinant Human Endostatin) in patients with Pediatric Neuroblastoma.

Detailed description: Clinical data proved that Endostar was a wild spectrum and safe antiangiogenesis factor which could suppress almost 65 kinds of tumor mass in animal models and affect about 12 percent human genome. So investigators design Radiotherapy plus Endostar to treat Pediatric Neuroblastoma to research the RR and safety. Investigators believe this treatment regimen may be a new approach to the pediatric neuroblastoma patients.

Eligibility: Inclusion Criteria:
  -  Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
  -  Life expectancy of greater than 12 months.
  -  ECOG performance status ≤2
  -  Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.
  -  Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  -  Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.
  -  Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.
  Exclusion Criteria:
  -  Patients will be ineligible if any prior therapeutic radiation therapy > 500 cGy has been delivered.
  -  Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.
  -  Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  -  Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

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

Clinical trial: Prospective Observational Study To Identify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management (IDEALK)

Summary: Prospective Observational Study To Identify Patients With Advanced/metastatic Non Small Cell Lung Cancer (NSCLC) And ALK Translocation And To Establish Their Therapeutic Management under clinical practice (IDEALK)


Eligibility: Inclusion Criteria:
  -  Patients with Advanced or metastatic non-small cell lung cancer
  -  Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
  -  Age > 18 years
  -  For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
  -  For the treatment sub-study, patients must also meet the following criteria
  -  Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
  -  Patients treated with crizotinib under routine clinical practice
  -  Patients with a minimum data registered at the medical history
  Exclusion Criteria:
  -  Any patient who does not meet any of the inclusion criteria defined in the previous section, depending on the sub-study for which they are included.

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

Clinical trial: Post-Marketing Assessment of Immunogenicity and Safety of Unituxin™ in High-Risk Neuroblastoma Patients

Summary: The purpose of this study is to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.

Detailed description: This is a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of high-risk neuroblastoma.

Eligibility: Inclusion Criteria:
  -  Patient has been diagnosed with high-risk neuroblastoma.
  -  Patient has been prescribed Unituxin and plans to start Unituxin therapy within 30 days of study entry.
  -  Patient must start Unituxin therapy no later than 200 days after Autologous Stem Cell Transplantation (ASCT).
  -  Written informed consent / assent must be obtained in accordance with institutional and ICH guidelines.
  Exclusion Criteria:
  -  Patient has received prior anti-GD2 antibody therapy.
  -  Patient has participated in an investigational clinical trial with tumor therapeutic intent within 30 days of informed consent.
  -  Patient underwent Autologous Stem Cell Transplantation (ASCT) more than 200 days prior to receiving Unituxin therapy.

Relevance to patient case: not relevant