araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

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: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: A Study to Test the Effect of the Drug Larotrectinib in Adults and Children With NTRK-fusion Positive Solid Tumors

Summary: This research study is done to test how well different types of cancer respond to the drug called larotrectinib. The cancer must have a change in a particular gene (NTRK1, NTRK2 or NTRK3). Larotrectinib is an experimental drug that blocks the actions of these NTRK genes in cancer cells and can therefore be used to treat cancer.

Detailed description: The primary objective of this study is to investigate the efficacy of larotrectinib for the treatment of advanced solid tumors harboring a fusion of neurotrophic tyrosine receptor kinase (NTRK) of types 1-3 in children and adults.
  Secondary objectives comprise the efficacy and safety of larotrectinib in different NTRK-tumor types.

Eligibility: Inclusion Criteria:
  -  Locally-advanced or metastatic malignancy with an NTRK1, NTRK2, or NTRK3 gene fusion identified through molecular assays
  -  Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy
  -  Subjects must have at least one measurable lesion as defined by RECIST v1.1
  Exclusion Criteria:
  -  Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting TRK. Subjects who received less than 28 days of treatment and discontinued because of intolerance or toxicity are eligible.
  -  Symptomatic or unstable brain metastases. (Note: Subjects with asymptomatic brain metastases are eligible to participate in the study.) Subjects with primary CNS tumors are eligible.
  -  Active uncontrolled systemic bacterial, viral, or fungal infection, unstable cardiovascular disease, or other systemic disease that would limit compliance with study procedures.
  -  Pregnancy or lactation.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: A Study in Adult Subjects With Select Advanced Solid Tumors

Summary: To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

Detailed description: This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Eligibility: Inclusion Criteria:
  -  All subjects must consent to provide archived tumor specimen
  -  Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
  -  At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
  -  Willingness to provide pretreatment and on-treatment biopsies.
  -  Adequate organ function
  -  Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception
  Exclusion Criteria:
  -  Known allergic reaction to any component of MEDI1873
  -  Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
  -  Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
  -  Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
  -  Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
  -  Unresolved toxicities from prior anticancer therapy
  -  Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib

Summary: This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were previously treated with chemotherapy and crizotinib, as measured by investigator-assessed progression-free survival (PFS) and to evaluate and compare between treatment groups the central nervous system (CNS) objective response rate (C-ORR) in participants with measurable CNS metastases at baseline, as assessed by an Independent Review Committee (IRC).


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. ALK positivity must have been determined by a validated fluorescence in situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)
  -  Participant had received two prior systemic lines of therapy, which must have included one line of platinum-based chemotherapy and one line of crizotinib
  -  Prior CNS or leptomeningeal metastases allowed if asymptomatic
  -  Participants with symptomatic CNS metastases for whom radiotherapy is not an option will be allowed to participate in this study
  -  Measurable disease by RECIST Version 1.1 prior to the administration of study treatment
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  -  For all females of childbearing potential, a negative pregnancy test must be obtained within 3 days before starting study treatment
  Exclusion Criteria:
  -  Participants with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal [GI] cancer by endoscopic resection or in situ carcinoma of the cervix)
  -  Participants who have received any previous ALK inhibitor other than crizotinib
  -  Any GI disorder that may affect absorption of oral medications

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Detailed description: Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
  To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility: Inclusion Criteria:
  -  Aged 18-80 Rheumatoid Arthritis patient;
  -  Patients must consent in writing to participate in the study by signing and dating an informed consent document;
  -  Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
  -  Stage I and II according to X-ray.
  Exclusion Criteria:
  -  History of neurological disease, head injury or psychiatric disorder;
  -  Pregnant women;
  -  Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
  -  Progressive apoplexy;
  -  With malignant tumors;
  -  Patients who had participated in other clinical trials within three months prior to this study.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sunitinib

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer

Summary: This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.
  The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.
  Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1
  Availability of tumor sample:
  Exclusion Criteria:
  Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

Summary: Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.
  The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark.
  This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods


Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer diagnosis
  -  Biopsy-verified ALK-translocation
  Exclusion Criteria:
  -  Patients were it is not possible to retrieve a biopsy
  -  Patients with squamous cell carcinoma

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Summary: Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Detailed description: Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program.
  This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Eligibility: Inclusion Criteria:
  -  Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
  -  Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
  -  Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
  -  Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
  -  Patient has taken at least 1 week of treatment
  Exclusion Criteria:
  -  Patient included in a crizotinib clinical trial
  -  Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Summary: The scleral buckle surgery is an effective way in treating retinal detachment (RD) patients. Retrobulbar block has been proved effective in scleral buckle surgery. Though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. Ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (LASEK), and so forth. The aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing RD surgery under retrobulbar anesthesia.


Eligibility: Inclusion Criteria:
  1. consent of the patient or legal guardian
  2. 18 years or above
  3. normal height and weight
  4. ASA class I, II
  5. elective surgery
  6. surgery time within 60min
  7. understanding of the verbal numerical rating score (0-10)
  Exclusion Criteria:
  1. history of ocular surgery, trauma or infection
  2. intraoperative complications
  3. glaucoma or ocular hypertension (> 20 mmHg)
  4. diabetic retinopathy
  5. diagnosis of asthma or coagulopathy
  6. chronic pain syndromes
  7. history of peptic ulceration, liver or hematologic disease
  8. history of chronic use of analgesics, sedatives, opioids or steroids
  9. history of drug or alcohol abuse
  10. history of systemic disease
  11. sexually transmitted disease (STD)
  12. Pregnancy, lactation;
  13. cognitive impairment or psychiatric illness;

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Next Generation Personalized Neuroblastoma Therapy

Summary: The purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents. This study will be done in two parts:
  Part I: Tumor will be accessed at study entry via a biopsy and subjected to deep sequencing to identify protocol-specified biomarkers for therapy assignment.
  Part II: If the tumor contains a genetic change defined by the study as being actionable, and other criteria are met, participants will be assigned to therapy based upon the genetic changes identified in the tumor biopsy.


Eligibility: Inclusion Criteria:
  -  Aged ≥1 years to ≤ 21 years
  -  Relapsed or refractory neuroblastoma
  -  A sufficient interval between the last dose of prior anti-cancer therapy (including cytotoxic and biological therapies) and enrollment in this study, to allow recovery from the acute toxic effects of all prior anti-cancer therapy. Please contact site for specific details
  -  Adequate bone marrow function (bone marrow may be involved with tumor. Contact site for specific details)
  -  Adequate renal function, defined as Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2 OR serum creatinine based on age/gender normal (contact site for details)
  -  Adequate liver function, defined as total serum bilirubin ≤ 1.5 times the upper limit of normal AND alanine transaminase (ALT) ≤ 110 U/L.
  -  Adequate cardiac function, defined as corrected QT interval (QTc) ≤ 480 msec AND shortening fraction > 27%
  -  Males and females who are sexually active must agree to use effective contraception during and for 3 months after treatment
  Exclusion Criteria:
  -  Subjects taking certain drugs or herbal medications that impact drug metabolism and/or cardiac function that cannot be discontinued (contact site for details).
  -  Subjects with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study (contact site for details)
  -  Other concomitant therapies:
  -  Corticosteroids initiated for tumor therapy within 7 days prior to study enrollment
  -  Other anti-cancer agents
  -  Other investigational drugs
  -  Hematological growth factors
  -  Radiation therapy
  -  Subjects < 0.5m2
  -  Pregnant or lactating females
  -  Sexually active males unless they use a condom during intercourse while taking study drug/s and for 3 months after study drug discontinuation and thus do not attempt to father a child in this period.

Relevance to patient case: not relevant