araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

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: definitely relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients

Summary: Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.


Eligibility: Inclusion Criteria:
  1. patients who were histologically and cytologically confirmed NSCLC at stage III or IV
  2. harbored ALK fusion gene and took crizotinib
  3. age:18~75years
  4. Eastern cooperative oncology group performance status(ECOG PS): 0~2 points
  5. the expected lifetime is more than 12 weeks after being recruited
  Exclusion Criteria:
  1. patients who also suffered from other malignant tumor
  2. uncontrolled systemic diseases,central nervous system (CNS) metastasis
  3. clinically active interstitial lung diseases
  4. severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points）
  5. taking drugs that interact with crizotinib

Relevance to patient case: definitely relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

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: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Doctor-Patient Communication in Lung Cancer Care

Summary: The purpose of this study is to better understand communication between patients with lung cancer and their doctors. The investigators are also interested in patient's perceptions of the quality of communication with his/her doctor and how these perceptions may impact patient outcomes. The doctor is participating in this study and has given us permission to approach his/her eligible patients for study participation.


Eligibility: Inclusion Criteria:
  -  Patients with confirmed lung cancer diagnosis or mass suspicious of lung cancer seen at MSK within past 0-3 months at time of consent as per clinician report and/or EMR
  -  Lung cancer treatment plan at MSK to include surgery, chemotherapy, radiation and/or immunotherapy within three months of the time of consent
  -  Participating physician approves his/her patient's participation in this study per physician report.
  -  Former (at least 100 cigarettes in lifetime and quit more than 30 days prior to enrollment) or current smoker (lifetime smoker who reports cigarette smoking within the past 30 days) as per self report or EMR;
  -  English fluency (determined through EMR or clinician report), as we do not have the resources to translate the consultations from other languages or the surveys to other languages;
  -  Patients must 18 years old or older
  Physician Inclusion Criteria:
  -  An MSK attending physician (radiologists, medical oncologists, and surgeons), who is a member of the Thoracic Disease Management Team currently treating thoracic patients at MSK as per self report
  Exclusion Criteria:
  -  Patient unable to comply with study procedures as determined by principal investigator.
  Physician Exclusion Criteria:
  -  Inclusion on protocol face-page (e.g., Bernard Park, MD)

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Perfusion CT Imaging in Lung Cancer With SBRT

Summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility: Inclusion Criteria:
  -  Gender: male or female
  -  CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
  -  Patient will sign a consent form prior to study entry
  -  Lung cancer and lung metastases are biopsy proven
  Exclusion Criteria:
  -  Patients who are unable to give valid informed consent
  -  Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Sleep Apnea in Lung Cancer: A Prospective Study

Summary: The study seeks to determine the prevalence of sleep disordered breathing in a population of patients diagnosed with lung cáncer.

Detailed description: Obstructive sleep apnea hypopnea syndrome (OSAHS) is an important medical condition which causes significant morbidity and mortality. The prevalence of OSAHS in Spain is 4-6% in men and 2-4% in women and rises steadily with age. Snoring and smoking have been independently linked, and smoking may be a risk factor for developing OSAHS. This is particularly true of heavy smokers (> 2 packs/day), those at greatest risk for LC. Associations between OSAHS and some forms of cancer have been described in humans, especially in those experiencing nocturnal hypoxemia, and intermittent hypoxia has been linked to the progression of cancer in animal models. LC is currently the leading cause of cancer deaths in developped nations. A link between OSAHS and LC, therefore, is plausible.
  Sleep disordered breathing may be common among patients recently diagnosed of lung cancer and may contribute to tumor progression.
  Objectives: a) To perform home sleep testing in patients recently diagnosed with lung cancer in order to determine the prevalence of sleep disordered breathing in this patient population. b) To include biological samples obtained from all participants, including surgically treated patients with stage I / IIp LC through the program in the CIBERES Pulmonary Biobank Platform. Biological samples will be preserved under different storage conditions for subsequent determination of molecular biomarkers. c) To follow-up lung cancer patients with and without sleep disordered breathing in order to determine the potential influence OSAHS might have on their prognosis.
  Prospective screening for sleep disordered breathing will be performed by home sleep testing in 100 subjects diagnosed with lung cancer, irrespective of stage at diagnosis, who give their consent. A modified epidemiologic questionnaire for sleep disordered breathing will also be administered. Patients identified as suffering from OSAHS will be referred to sleep clinic. Biologic samples and lung function studies will be obtained in all participating patients.
  All patients with lung cancer will undergo follow-up for at least three years or until their demise, and those identified with OSAHS will also be followed in sleep clinic. The prevalence of OSAHS in this patient population will be determined. A link between OSAHS, and especially intermittent nocturnal hypoxemia, and tumor progression will be sought.

Eligibility: Inclusion Criteria:
  -  All patients with recently diagnosed lung cancer, inlcuding all stages of disease.
  Exclusion Criteria:
  -  Patients unable to comply with home sleep testing.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Summary: The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility: Inclusion Criteria:
  -  1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
  -  2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
  Exclusion Criteria:
  -  1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  -  2. Pregnancy and/or breast feeding
  -  3. Current participation in any interventional trial

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Predictors of Pulmonary Hypertension in Patients With Advanced Lung Diseases

Summary: First, the aim of the study was to evaluate the usefulness of echocardiographic parameters for detecting pulmonary hypertension (PH) in patients with advanced lung disease referred for lung transplantation. Second, to assess the prevalence of PH and to identify which hemodynamic, echocardiographic, pulmonary functional test, exercise capacity and biochemical parameters (especially NT-proBNP) have an impact on survival in a cohort of patients with severe lung diseases referred for lung transplantation.


Eligibility: Inclusion Criteria:
  -  advanced lung disease
  -  qualification for lung transplantation
  -  written informed consent
  -  pulmonary capillary wedge pressure < 15 mmHg
  Exclusion Criteria:
  -  cancer,
  -  history of idiopathic pulmonary hypertension,
  -  primary valvular heart diseases,
  -  coronary artery disease,
  -  collagen vascular disease,
  -  history or evidence of left ventricular dysfunction,
  -  atrial fibrillation,
  -  increased liver enzyme levels ( 3 times the upper laboratory limit),
  -  renal dysfunction (estimated glomerular filtration rate < 60 ml/min/1.73m2)
  -  patients who didn't write the personal informed consent
  -  any specific therapy for PH.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Summary: Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.


Eligibility: Inclusion Criteria:
  1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
  2. Non-small cell lung cancer patients.
  3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
  4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
  5. Expected survival time is greater than 1 month.
  Exclusion Criteria:
  Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Acquired Resistant Mechanism of the First-generation EGFR TKIs

Summary: Patients with advanced non-small-cell lung cancer (NSCLC) harboring sensitive epithelial growth factor receptor (EGFR) mutations invariably develop acquired resistance to EGFR tyrosine kinase inhibitors (TKIs). Identification of actionable genetic mutations can be helpful for guiding the subsequent treatment. This study aimed to analyze the genetic profile of NSCLC harboring acquired resistance to the first-generation EGFR TKIs using next generation sequencing (NGS).


Eligibility: Inclusion Criteria:
  -  Histologically proven stage IIIB or IV non-small cell lung cancer
  -  patients harboring sensitive EGFR mutations and received first-generation EGFR-TKIs who developed acquired drug resistance
  -  patients who can provide pre-treatment (EGFR TKIs) tumor tissues
  -  patients with tumor lesions to be re-biopsy after drug resistance
  -  patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.
  Exclusion Criteria:
  -  History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
  -  patients with other systemic diseases

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

Summary: The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer


Eligibility: Inclusion Criteria:
  -  Patients aged 18 years or older
  -  Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
  -  Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
  -  Existence of at least 1 measurable lesion by RECIST v1.1
  -  Adequate hematological, renal and liver function
  -  Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
  -  Life expectancy longer than 6 months
  Exclusion Criteria:
  -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
  -  Any unresolved toxicities from prior systemic therapy
  -  Known sensitizing EGFR mutations or EML4-ALK translocation positive mutations
  -  Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
  -  Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy
  -  Use of prohibited concomitant medication
  -  Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
  -  Fertile men or women of childbearing potential not using adequate contraception.
  Other inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: PDL-1 Expression on Circulating Tumor Cells in Non-small Cell Lung Cancer

Summary: Immunotherapy is probably, since the development of therapies targeting EGFR mutations or ALK rearrangement, the most attractive therapeutic perspective in the management of metastatic lung cancer. Among the compounds tested, the inhibitors of the immune checkpoint PROGRAMME DEATH 1 / PROGRAMME DEATH LIGAND 1 (PD-1/PD-L1) have been tested in numerous clinical trials with recently published positive results leading to the approval of one drug in the USA and an expanded access program for two drugs in France. PROGRAMME DEATH LIGAND 1 (PD-L1) expression by tumor cells is strongly associated with the response to such molecules so that the participation in various clinical trials is currently reserved for patients expressing this biomarker and therefore justifies a new invasive biopsy (bronchoscopic or CT-guided) representing a considerable drag on the access to these treatments. Circulating tumor cells (CTCs) isolated by Isolation by Size of Tumor Cells (ISET) offer a direct and non-invasive access to the tumor. It has already been demonstrated that molecular characterization (EGFR, ALK) on these blood samples is possible. We propose to demonstrate the feasibility of the analysis PDL-1 expression in these cells by immunocytochemistry.
  Myeloid-Derived Suppressor Cells (MDSCs) are immature myeloid cells that inhibit T cell functions and thus promote tumor growth. These cells frequently express PD-L1. We propose to test whether MDSCs level and its evolution during treatment with PD1 inhibitor is correlated to the response to these drugs.
  The main objective of this study is to demonstrate the feasibility of the analysis of PD-L1 expression on CTC


Eligibility: Inclusion Criteria:
  -  Stage IV non-small cell lung cancer patient prior to start immunotherapy treatment
  -  Patients with World Health Organization (WHO) performance status 0-3
  -  Patients who were informed and had non opposition form signed by investigator
  -  Patients with healthcare insurance system affiliation
  Exclusion Criteria:
  -  Prior malignancy within 5 years of study entry
  -  Refusal to participate
  -  Patient under legal protection

Relevance to patient case: not relevant