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

Clinical trial: Personalized Sequence for Thoracic, Esophageal, and H&N Cancer

Summary: The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information Therefore, a big data of genome-clinical information is important.

Detailed description: To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(PFS, duration of response and overall survival) of patients with advanced cancer, the investigators are going to take a fresh tissue of patients and process molecular profiling.

Eligibility: Inclusion Criteria:
  -  metastatic, histologically confirmed NSCLC, head & Neck Cancer, Esophageal cancer
  Exclusion Criteria:
  -

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 of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110]

Summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC
  -  No prior treatment for Stage IV non-squamous or squamous NSCLC. Participant known to have a sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene are excluded from the study
  -  Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  -  Adequate hematologic and end-organ function
  Exclusion Criteria:
  -  Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
  -  Active or untreated central nervous system (CNS) metastases as determined by Computed Tomography (CT) or magnetic resonance imaging (MRI) evaluation
  -  Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  -  Pregnant or lactating women
  -  History of autoimmune disease
  -  History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  -  Positive test for Human Immunodeficiency Virus (HIV)
  -  Active hepatitis B or hepatitis C
  -  Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
  -  Severe infection within 4 weeks prior to randomization
  -  Significant history of cardiovascular disease

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

Clinical trial: Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear

Summary: In this prospective randomized controlled double blind pilot clinical study, we aim to assess whether administration of a topical corticosteroid would attenuate epiretinal membrane formation following development of retinal tears treated with laser retionpexy.

Detailed description: Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% - 28.9% of eyes in persons aged 40 years or older. [1] While often idiopathic in nature, ERM formation has been associated with retinal tears, possibly due to a breakdown of the blood-retinal barrier [1-3]. Pathological analysis of ERM content shows inflammatory mediators such as cytokines, growth factors and interleukins, which can promote fibroblast remodelling that leads to a contractile scar formation on the retinal surface. [1, 4-8] For this reason, ERM formation has been suggested to be an aberrant tissue repair or wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid following retinal tears should theoretically reduce the risk of ERM formation. [9-10] In this study, we aim to assess whether administration of a topical corticosteroid would attenuate ERM formation following laser retinopexy of retinal tears.

Eligibility: Inclusion Criteria:
  -  Between ages 18 to 80 (inclusive)
  -  English-speaking
  -  Undergoing non-pneumatic laser retinopexy procedure for horseshoe retinal tear (without retinal detachment)
  Exclusion Criteria:
  -  Patient refusal or delay of retinopexy procedure for more than 48 hours after diagnosis
  -  Patients who are pseudophakic or aphakic
  -  Medical conditions contraindicated with prednisolone: viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fundal diseases of ocular structures; mycobacterial infections; hypercortisolism.
  -  Previous history of epiretinal membrane, retinal surgery (cryo or laser)
  -  Patients with hypersensitivity or contraindication for corticosteroids (viral diseases of the cornea and conjunctiva including herpes simplex, vaccinia, varicella; fungal diseases of ocular structures; mycobacterial infections; hypercortisolism).

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

Clinical trial: Evaluation of Bone Union Following Anterior Cervical Fusion Using a NovoMax™

Summary: The purpose of this study is to evaluate the efficacy and safety of NovoMax™ in Anterior Cervical Interbody Fusion - Comparison of NovoMax™ versus ChronOs®.


Eligibility: Inclusion Criteria:
  -  The patient who is expected to receive anterior cervical discectomy and fusion operation.
  -  Volunteer for this study with written consent.
  Exclusion Criteria:
  -  Patient with cervical spine fracture, infection and malignant tumor
  -  Below -3.5 T-score by DEXA bone densitometry
  -  Patient who is not suitable for this study judged by principal investigator

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

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

Clinical trial: Study of Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein

Summary: The purpose of this study is to evaluate the dosages of recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein by injection for preventing neutrophilic granulocytopenia among chemotherapy patients.
  Conduct Pharmacokinetics (PK) study on recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with recombinant human granulocyte colony-stimulating factor injection as a control.

Detailed description: -  Brief Protocol: Treat the patients taking Taxotere+Epirubicin+Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE) treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
  -  Positive control：recombinant human granulocyte colony-stimulating factor injection.
  -  Targeted patients: breast cancer
  -  Grouping: Group 1: 1.2 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 2: 1.5 mg recombinant human serum albumin/granulocyte colony-stimulating factor fusion protein with TEC or TE treatment; Group 3: positive control with TEC or TE treatment.
  -  Number of patients: 216
  -  Concomitant medicines will be conducted.

Eligibility: Inclusion Criteria:
  -  Age 18-65.
  -  Diagnosed breast cancer, suitable for TEC or TE .
  -  ECOG performance status 0 or 1.
  -  Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
  -  ANC≥1.5×10 9/L, PLT≥100×10 9/L. No bone marrow metastasis,blood coagulation function normally, no Hemorrhagic tendency.
  -  No obvious abnormal ecg examination.
  -  TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
  -  Cr, BUN≤2.5×ULN.
  -  Signed informed consent.
  Exclusion Criteria:
  -  Chemotherapy within past 4 weeks
  -  Uncontrolled inflammatory disease,axillary temperature≥38℃.
  -  Merging other malignant tumor
  -  Pregnancy or nursing status.
  -  Participation in another clinical trial with and investigational product within 3 months prior to study entry.
  -  Severe diabetes mellitus, or poor blood sugar controller.
  -  Allergic disease or allergic constitution. History of protein allergy.
  -  History of drug addiction and alcoholism.
  -  Hematopoietic stem cell transplantation or organ transplantation.
  -  Chronic disease of severe cardiac, kidney and liver.
  -  Other conditions that would be excluded from this study according to doctors'judgment

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

Clinical trial: ALK Rearrangements in Lung Adenocarcinoma: Epidemiology in Latin America (CLICaP)

Summary: Evaluation of the frequency and clinical characteristics of ALK rearrangements in Latin-American countries.
  Latin American countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. The discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (EML4-ALK) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.

Detailed description: The precise frequency of ALK in Latin American population has not been determined. Studies isolated in some Latin American countries like Brazil report a frequency of 3.2%, Argentina of 4.2% and Mexico of 9.0% of ALK fusion in a small number with lung cancer. Reliable information about ALK frequencies and disparities among ethnic groups is critical. Our study pretends to know the frequency and clinical characteristics of ALK rearrangement of Latin American patients with NSCLC. Discusses the difficulty of having a single diagnostic test for this chromosome abnormality.
  The development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. Currently, the current gold standard for testing for EML4-ALK translocation is fluorescent in situ hybridization (FISH) for selecting patients for ALK-tyrosine kinase inhibitors (TKI) therapy according to the United States Food and Drug Administration (FDA). But, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. Recent evidence suggests that ALK Immunohistochemistry (IHC) instruments globally protocols, can be very effective in the detection of ALK rearrangement in NSCLC (ALK+) tumors expressing the fusion ALK protein.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed lung cancer and tissue availability for ALK analysis.
  Exclusion Criteria:
  -  Not lung cancer

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

Clinical trial: Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients

Summary: The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.

Detailed description: The patients will be screened for up to 28 days before they start treatment to determine if they meet eligibility criteria. The screening procedures will include physical examination, blood work and radiological scans.
  In the dose finding phase, patients who meet eligibility criteria will receive crizotinib at the dose level assigned that will be taken on daily basis and pembrolizumab 200 mg intravenous infusion every 3 weeks.
  Once a Crizotinib dose level is decided, the dose expansion cohort will start enrolling patients who meet eligibility criteria.
  All patients will be followed up every three weeks. Blood samples will be drawn to test for safety and tumor activities and radiological scans will be performed on certain timepoints to determine the antitumor activities.
  There will be a quality of life questionnaire administered at certain time points during the study.
  The study will have a quality assurance plan that addresses data validation and registry procedures. There is a plan to visit the investigator site for routine monitoring and auditing.
  The team will conduct source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms, or interactive voice response systems).
  The study will also include a statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives of this study, as specified in the study protocol or statistical plan.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous NSCLC that is not suitable for local curative treatment.
  -  Alk-positive NSCLC as determined by a test that is approved or validated for use as a companion diagnostic test.
  -  No prior systemic therapy for metastatic disease.
  -  Adjuvant chemotherapy more than 12 months prior to study enrollment.
  -  Measurable disease as per RECIST 1.1
  -  ECOG PS 0 or 1.
  Exclusion Criteria:
  -  Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any drug targeting T-cell checkpoint pathways.
  -  known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
  -  Active autoimmune disease that has required systemic treatment in the past 3 months.
  -  History of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease.

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 Apatinib in RET Fusion Positive Advanced Non-small Cell Lung Cancer

Summary: RET fusions are present in 1% to 2% of unselected population of non-small cell lung cancer (NSCLC). Existing US Food and Drug Administration-approved inhibitors of RET tyrosine kinase show promising therapeutic effects in a non-small cell lung cancer patients. Apatinib is an oral multi-kinase inhibitors including RET fusions. This study is designed to evaluate the safety and tolerability of Apatinib in patients with RET fusion positive advanced NSCLC.

Detailed description: To observe objective response rate (ORR) of apatinib in RET fusion positive pre-treated advanced NSCLC.
  To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess safety and tolerability. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of apatinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed RET fusion positive advanced Non-small cell lung cancer who failed to prior therapies.
  -  Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent
  -  Females of child-bearing potential must have negative serum pregnancy test. Sexually active male and those having childbearing potential must practice contraception during the study.
  Exclusion Criteria:
  -  Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Obvious cavity or necrosis formed in the tumor
  -  Uncontrolled hypertension
  -  Hymoptysis, more than 2.5ml daily
  -  Thrombosis in 12 months, including pulmonary thrombosis, stroke, or deep venous thrombosis
  -  Received big surgery, had bone fracture or ulcer in 4 weeks
  -  Urine protein >++, or urine protein in 24 hours> 1.0g
  -  pregnant or lactating woman
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to apatinib or any of it components.

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

Clinical trial: Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

Summary: MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification [increase number of gene copies]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

Detailed description: If testing has not already been performed, the study will provide for the testing.

Eligibility: Inclusion Criteria:
  -  Diagnosis of non-small cell lung cancer
  -  Metastatic or locally advanced disease
  -  Prior platinum chemotherapy or immunotherapy
  -  Test result showing genetic change in MET tumor gene
  -  At least one tumor that can be measured on a radiographic scan
  Exclusion Criteria:
  -  Prior treatment with inhibitor of MET or HGF
  -  Prior positive test for EGFR mutation or ALK gene rearrangement
  -  Uncontrolled tumor in the brain

Relevance to patient case: not relevant