araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Study of Proteins in Tumor Samples From Patients With Non-Small Cell Lung Cancer

Summary: This research studies protein in tumor samples from patients with non-small cell lung cancer. Finding specific proteins in tumor tissue samples from patients with cancer may help doctors tell what type of lung cancer a patient has and plan better treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To validate a novel 4-protein signature's ability to subtype non-small cell lung cancer (NSCLC) in a treatment-naive, multi-institutional cohort, Cancer and Leukemia Group B (CALGB) 9761.
  SECONDARY OBJECTIVES:
  I. To estimate the NSCLC misclassification rate in a multi-institutional clinical-trial setting for stage 1 NSCLC (adenocarcinoma versus squamous cell).
  OUTLINE:
  Previously collected tissue samples are analyzed via hematoxylin and eosin (H&E) staining and immunohistochemistry (IHC).

Eligibility: Inclusion Criteria:
  -  Patients must have been registered on CALGB-9761
  -  Stage I disease
  -  Treatment-naive patients
  -  A representative paraffin block of the primary tumor must be available from patients on CALGB-9761 and submitted to the CALGB Pathology Coordinating Office
  -  A separate consent form is not required for this study, as permission for research to be performed on the tissue blocks is included in the consent form for CALGB 9761
  -  Institutional review board (IRB) review and approval at the institution where the laboratory work will be performed is required

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema

Summary: The PneumRx Lung Volume Reduction Coil (LVRC) has been shown to effectively improve quality of life, exercise capacity, and static lung volumes, in patients with emphysema. The mechanism of action for these effects is believed to be related to the restoration of elastic recoil to lung parenchyma that has been damaged by emphysema. The objective of this study is to evaluate several physiologic parameters which should provide measures directly related to the mechanism of action by which the coils produce these outcomes.


Eligibility: Inclusion Criteria:
  Subject > 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form
  Exclusion Criteria:
  Subject has a history of recurrent clinically significant respiratory infection Subject has uncontrolled pulmonary hypertension Subject has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc Subject is pregnant or lactating Subject has an inability to tolerate bronchoscopy Subject has clinically significant bronchiectasis Subject has giant bullae Subject has had previous LVR surgery, lung transplant or lobectomy Subject has been involved in other pulmonary drug studies with 30 days prior Subject has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Implantation of Endobronchial Valves Versus Intrabronchial Valves in Patients With Severe Heterogeneous Emphysema

Summary: Patients with advanced heterogeneous emphysema experience improvement in clinical outcomes in the same way following either implantation of endobronchial valves or intrabronchial valves.

Detailed description: Patient enrollment and data acquisition is to be carried out on a prospective basis. It is planned to enroll a total of 50 patients with advanced heterogeneous emphysema. After decision to undertake endoscopic lung volume reduction by valve implantation patients will be randomised to two treatment arms. 25 patients receive unilateral IBV treatment or unilateral EBV treatment in each case. All patients will undergo treatment at one study centre in Heidelberg.

Eligibility: Inclusion Criteria:
  -  pulmonary function: FEV1 < 45 %, RV > 150 %, TLC > 100 %
  -  heterogeneous emphysema
  Exclusion Criteria:
  -  homogeneous emphysema
  -  significant bronchiectasis
  -  severe concomitant diseases
  -  pregnancy

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy

Summary: to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management


Eligibility: Inclusion Criteria:
  -  A. Clinically and radiologically suspected lung adenocarcinoma
  -  B. Newly-diagnosed Stage I or II from the clinical work up including PET/CT
  -  C. Performance status of 0 to 1 on the ECOG scale
  -  D. Age 20 years or older
  -  E. Able to tolerable DECT imaging required by protocol
  -  F. Able to give study-specific informed consent
  Exclusion Criteria:
  -  A. Prior malignancy
  -  B. planning of Definitive RTx 나 neoadjuvant CCRTx
  -  C. Poor cardiopulmonary reserve

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Summary: MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility: Inclusion Criteria:
  -  Rectal adenocarcinoma
  Exclusion Criteria:
  -  Metastatic disease
  -  under 18y patient
  -  woman of childbearing age

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer

Summary: This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have received only one prior chemotherapy regimen for advanced NSCLC and this regimen must have been platinum-based. Primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. Secondary objectives are to evaluate clinical efficacy including median progression-free survival (PFS) and 1-year PFS rate, overall survival (OS), disease control rate (DCR) at 6 and 12 weeks, time to response (TTR), and duration of response (DR).


Eligibility: Inclusion Criteria:
  -  Proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung
  -  Positive for translocation or inversion events involving the ALK gene locus
  -  Patients must have had progressive disease after only one prior chemotherapy regimen. This regimen must have been platinum-based and may have included maintenance therapy.
  -  Evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  Exclusion Criteria:
  -  Current treatment on another therapeutic clinical trial.
  -  Prior therapy directly targeting ALK.
  -  Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
  -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc interval >470 msec.
  -  Pregnancy or breastfeeding.
  -  Use of drugs or foods that are known potent CYP3A inducers/inhibitors/substrates with narrow therapeutic indices.
  -  Known HIV infection
  -  Known interstitial lung disease or interstitial fibrosis
  -  Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Summary: The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Detailed description: Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Eligibility: Inclusion Criteria:
  -  Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
  -  Patients under 1st line treatment against lung adenocarcinoma.
  Exclusion Criteria:
  -  Patients not having the information required by the protocol.

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Summary: The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Detailed description: Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Eligibility: Inclusion Criteria:
  1. Histological or cytological diagnosis of lung adenocarcinoma histology with brain metastases
  2. 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 3 (poor PS caused by neurological symptom)
  4. Appraisable intracranial disease, the presence of at least one lesion, and the longest diameter > 5 mm by brain MRI
  5. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  6. Total bilirubin 1.5 x upper limit of normal (ULN)
  7. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
  8. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
  9. If received brain radiotherapy, patients included at least 8 weeks after the end of radiotherapy.
  Exclusion Criteria:
  1. Mixed non-adenocarcinoma cell lung cancer histology
  2. Previous treatment with pemetrexed or tarceva
  3. Be allergic to pemetrexed or tarceva

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma

Summary: The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.

Detailed description: This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
  -  No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
  -  Adequate organ and bone marrow function
  Exclusion Criteria:
  -  Prior chemotherapy or radiation therapy for NSCLC
  -  Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
  -  Patients with known hypersensitivity to other recombinant human antibodies
  -  History of stroke or transient ischemic attack (TIA).
  -  History of myocardial infarction or unstable angina within the past 12 months.
  -  Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
  -  Women who are pregnant or breast-feeding

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Detection of Chromosomal Aberrations in Non-small Cell Lung Cancer (NSCLC) Using Fluorescent in Situ Hybridization (FISH) (ALK Test)

Summary: The purpose of the study is the identification of chromosomal aberrations in non-small cell lung cancer (NSCLC) .
  The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ALK FISH stained lung samples.

Detailed description: The ALK Break Apart FISH test detects chromosomal aberrations via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. The FDA approved ALK kit is designed to detect rearrangements involving the ALK gene (2p23). Results from the ALK Kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for the pathologist in the identification of patients eligible for treatment with XALKORI® (crizotinib).

Eligibility: Inclusion Criteria:
  -  Well stained slides with bright FISH signals
  Exclusion Criteria:
  -  Very old slides that were already bleached

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK)

Summary: Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

Detailed description: Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.
  FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning.
  The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population.
  Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

Eligibility: Inclusion Criteria:
  -  The only inclusion criterion was the availability of tissue for biomarker studies.
  Exclusion Criteria:
  -  Disease Progression

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Pulmonary Rehabilitation Before Lung Cancer Resection

Summary: This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).


Eligibility: Inclusion Criteria:
  -  Patient is scheduled to undergo a surgery for non small cell lung cancer
  -  Moderate to severe COPD
  -  Current or ex smoker of ten or more years
  Exclusion Criteria:
  -  Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

Summary: This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.


Eligibility: Inclusion Criteria:
  -  Heterogeneous emphysema with upper lobe predominance in both lungs
  -  FEV1 between 20% and 45% predicted
  -  Residual volume (RV) > 150% predicted
  -  Post-rehabilitation 6-minute walk test > 140 meters
  Exclusion Criteria:
  -  More than 3 COPD related hospitalizations requiring antibiotics in past 12 months
  -  FEV1 < 20% predicted
  -  DLCO < 20% predicted or immeasurable DLCO
  -  Body mass index (BMI) < 18kg/m2 or > 32 kg/m2
  -  History of any of the following:
  -  Left ventricular ejection fraction (EF) ≤ 40%
  -  Stroke
  -  Myocardial infarction or acute coronary syndrome in previous year
  -  Hospitalization due to left ventricular failure in previous 3 years

Relevance to patient case: not relevant
Patient case: 64-year-old female with Lung adenocarcinoma. Genetic variant: ALK Fusion. Other conditions: Emphysema.

Clinical trial: Phase Ib Study of LDK378 and AUY922 in ALK-rearranged Non-small Cell Lung Cancer

Summary: The primary purpose of the study is to estimate the maximum tolerated dose of the combination of LDK378 and AUY922. This study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of LDK378 and AUY922 in ALK-rearranged non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  locally advanced or metastatic NSCLC that has progressed during or following therapy with an ALK inhibitor
  -  tumor must carry an ALK rearrangement in 15% or more of tumor cells as measured by FISH
  -  disease that can be evaluated by RECIST v1.1 and measurable disease
  Exclusion Criteria:
  -  central nervous system (CNS) metastases that are symptomatic or require increasing steroids or CNS-directed therapy to control CNS disease
  -  history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis
  -  clinically significant cardiac dysfunction
  -  inadequate end organ function as defined by specified laboratory values
  -  use of medications known to be strong inhibitors or inducters of CYP3A4/5 that cannot be discontinued at least 1 week prior to start of treatment
  -  use of medications that are mainly metabolized by CYP3A4/5 or CYP2C9 that cannot be discontinued at least 1 week prior to start of treatment
  -  clinically significant, uncontrolled impaired gastrointestinal function or GI disease
  -  prior treatment with a HSP90 inhibitor
  -  radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities
  -  pregnant or nursing women
  -  history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.

Relevance to patient case: possibly relevant