araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

Summary: This study is primarily designed to assess the safety and tolerability of AZD4547 at increasing doses in patients with advanced solid malignancies and for whom no standard medication options are available. It also assesses the blood levels and action of AZD4547 in the body over a period of time.


Eligibility: Inclusion Criteria:
  -  Minimum life expectancy of 12 weeks
  -  The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
  -  In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
  -  Expansion, 5 groups of advanced cancer
  -  Solid tumours,FGFR1 and/or FGFR2 gene amplified
  -  Squamous NSCLC, FGFR1 gene low & high amplified
  -  Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
  -  Aged at least 25 years
  Exclusion Criteria:
  -  Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
  -  An inability to be able to take the study medication
  -  A bad reaction to AZD4547 or any drugs similar to it in structure or class.

Relevance to patient case: possibly relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

Summary: The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.


Eligibility: Inclusion Criteria:
  -  Patients with histologically/cytologically confirmed advanced solid tumors with FGFR1 or FGFR2 amplification or FGFR3 mutation, for which no further effective standard anticancer treatment exists
  -  Adequate bone marrow function
  -  Adequate hepatic and renal function
  -  Adequate cardiovascular function
  -  Contraception.
  -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be nursing.
  -  For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
  -  History and/or current evidence of ectopic mineralization/ calcification including but not limited to the soft tissue, kidneys, intestine, myocard and lung with the exception of calcified lymphnodes and asymptomatic coronary calcification
  -  Current evidence of corneal disorder/ keratopathy incl. but not limited to bullous/ band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis etc., confirmed by ophthalmologic examination.
  -  History or current evidence of cardiac arrhythmia and/or conduction abnormality
  -  Women who are pregnant or nursing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer

Summary: The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

Detailed description: In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Eligibility: Inclusion Criteria:
  -  Histopathologic diagnosis of non small-cell lung cancer
  -  Clinical stage IV
  -  ECOG functional status 0 or 1
  -  No renal function alteration (GFR >50%)
  -  No hepatic function alteration (ALT and AST less than 2 times its normal value)
  -  Leucocytes more than 2,000/mcl
  -  Hemoglobin more than 10mg/dL
  -  Platelets more than 100,000/mcl
  Exclusion Criteria:
  Non-advanced disease

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

Summary: Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female.
  The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
  2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
  3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
  4. Never smoker (less than 100 cigarette for the life time)
  5. 18 year or older
  6. ECOG 0-2
  7. No history of biologic or immunotherapy
  8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
  9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)
  Exclusion Criteria:
  1. symptomatic brain metastasis
  2. previously treated with EGFR tyrosine kinase inhibitor
  3. previously treated with antifolate agents
  4. poor oral absorption
  5. patients with active infection
  6. uncontrolled diabetes mellitus
  7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
  8. pregnant or nursing patients
  9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD)

Summary: The main purpose of this project is to establish the additional value of eccentric versus concentric exercise to optimize muscle function in patients with severe COPD. With this pilot project the investigators expect that an eccentric endurance training protocol adapted to severe COPD patients will lead to gains in muscle strength, the primary outcome, and cellular adaptation (muscle morphology and oxidative capacity, mitochondrial respiratory capacity) when compared to a concentric training approach.
  This information will be essential if the investigators want to design and power a randomized clinical trial that will allow assessing effectiveness of this novel rehabilitation approach.

Detailed description: Chronic obstructive pulmonary disease (COPD) is a major respiratory illness that is both preventable and treatable. Dyspnea is the most important symptom that COPD patients experience and this can have a major impact on their daily live. While COPD is characterized by a spectrum of disease severity, most patients experience poor exercise intolerance attributable to ventilatory limitation as well as peripheral muscle fatigue, ultimately leading to severe disability.
  Endurance exercise is an important component of pulmonary rehabilitation and is aimed at preventing this decline in functional capacity. The effects of pulmonary rehabilitation are largely attributable to the exercise training component involving concentric muscle contractions, traditionally trough dynamic, large muscle exercise on a cycle ergometer or treadmill. However, many patients are unable to partake and benefit from such rehabilitation because of locomotor muscle weakness and severe ventilatory limitation that prevent them from exercising at intensities sufficient to provoke improvements in cardioventilatory and skeletal muscle function. Eccentric exercise is known for its unique physiologically fundamental characteristics: the lower metabolic demand for a same power output and greater muscle gains compared to the concentric exercise. For this reason, eccentric endurance training has been proposed as a novel adjunctive rehabilitative countermeasure for certain chronic diseases (such as coronary disease and COPD) and can play an important role for patients with advanced disease.

Eligibility: Inclusion Criteria:
  -  male patients with severe COPD (FEV1/FVC < 0.70 and FEV1 ≤ 50% predicted of normal)
  -  Patients aged 40 to 75 years old in whom exercise is not contraindicated
  -  Current and ex-smokers
  -  Patients who do not require oxygen therapy
  Exclusion Criteria:
  -  Patients presenting neurological or orthopedic problems, morbid obesity, acute medical condition or recent exacerbations (in the last four weeks)
  -  Patients with recent or current participation in a rehabilitation program
  -  Patients who are currently taking Coumadin or Plavix

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Internet-Based Clinical Information and Blood Sample Collection From Patients With Non-Small Cell Lung Cancer Who Never Smoked Cigarettes

Summary: RATIONALE: Gathering health information about patients with non-small cell lung cancer who never smoked cigarettes may help doctors learn more about the disease. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.
  PURPOSE: This research study is studying internet-based clinical information and blood sample collection from patients with non-small cell lung cancer who never smoked cigarettes.

Detailed description: OBJECTIVES:
  -  To assess the feasibility of an internet-based protocol to collect clinical information and biological specimens from 2,000 never smokers with non-small cell lung cancer.
  -  To perform genome-wide association studies to identify alleles that predispose to lung cancer in patients that never smoked cigarettes.
  OUTLINE:
  Patients complete an internet-based questionnaire using the REDCap (Research Electronic Data Capture) survey to determine eligibility. The survey consists of a detailed smoking questionnaire and questions to collect information regarding diagnosis, sex, age, ethnicity, treatment history, and any history of previous malignancies. Blood samples are then collected from eligible patients for DNA and other laboratory analyses. Patients' pathology reports are also reviewed.

Eligibility: Inclusion Criteria:
  -  18 years or older
  -  histologically and/or cytologically proven diagnosis of non-small cell lung cancer
  -  never smoker, defined as having smoked less than 100 cigarettes over one's life-time
  -  completed survey and inclusion form
  -  signed informed consent
  Exclusion Criteria:
  -  previous history of cancer (other than lung cancer, except for superficial skin cancers)
  -  living outside the United States
  -  patients who cannot read English (as materials will only be written in English)
  -  unable to understand the protocol or to give informed consent

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Early Detection of Lung Tumors by Sniffer Dogs - Evaluation of Sensitivity and Specificity

Summary: Some groups reported that sniffer dogs can be applied to detect lung cancer in the exhaled breath of patients. Therefore, breath samples (BS) of patients are collected. Five sniffer dogs are trained to distinguish between the BS of patients with lung cancer and healthy individuals (controls). In a prospective, randomized blinded study the dog's ability to differentiate between BS of i) patients with lung cancer, ii) patients with inflammatory airway disease, but no evidence of cancer and iii) healthy individuals is tested.

Detailed description: All breath samples (BS) are collected in patients on the basis of radiologic findings before any intervention (bronchoscopy, biopsy or surgery) has been performed. The allocation to study groups is made following diagnostic work up and surgery.
  Three study groups are defined using the following inclusion and exclusion criteria:
  -  lung cancer: male & female, age 18-80, competent, confirmed lung cancer in diagnostic work up and surgery, no history or present other tumor disease
  -  healthy individual: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, no pathological lung function tests
  -  chronic obstructive lung disease: male & female, age 18-80, competent, no history or present other tumor disease including lung cancer, pathological lung function tests
  For each patient, i) history, ii) present medication, iii) lung function tests are documented. For the lung cancer patients, the tumor stage following surgery is documented.
  Five sniffer dogs are trained using BS of lung cancer patients and healthy individuals. After completion of the training the ability of the dogs to differentiate between the groups is tested:
  -  5 BS are presented in 1 experiment:
  -  Test I: lung cancer vs healthy individual
  -  Test II: lung cancer vs chronic obstructive pulmonary disease
  -  Test III: lung cancer vs healthy individuals & bronchitis
  -  for every experiment 1 BS of a lung cancer patient is used
  -  the lung cancer sample is placed randomly in one of the five test tubes
  -  the other test tubes are used for BS of healthy individuals or chronic obstructive pulmonary disease patients or both
  -  neither the dog handler nor the dog know the loading of the test tubes
  -  experiments are repeated 5 to 10 times
  For analysis, the sensitivity and specificity of the dog's reaction is determined.
  The patient's medication, smoking habits, age and gender are analysed to rule out confounders or bias.

Eligibility: Inclusion Criteria:
  -  age 18-80
  -  competent
  -  confirmed lung cancer
  Exclusion Criteria:
  -  history of other cancers

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Pazopanib and Paclitaxel for Non-Small Cell Lung Cancer

Summary: Lung cancer is the leading cause of cancer worldwide with approximately 1.2 million new cases each year. Non-small cell lung cancer (NSCLC) accounts for greater than 80% of all lung carcinomas in Western countries. Surgical resection is the treatment of choice for patients with early stage disease (Stage I and II), but at least 50% of these patients will relapse locally and/or develop distant metastases. Furthermore, 70% of patients with NSCLC are non-resectable at the time of their diagnosis due to either locally advanced or metastatic disease. The long-term prognosis for patients with NSCLC remains poor with the overall 5-year survival rate less than 15%. The low survival rate may be attributed to the high incidence of unresectable disease at presentation and the inability of systemic therapy to cure metastatic disease. There is a clear need for improvement in the treatment of NSCLC.

Detailed description: The primary objective of this study is to evaluate the objective response rate of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1). A subject is defined as a responder if he/she sustains a complete response (CR) or a partial response (PR) for at least 4 weeks at any time during treatment. A subject without a post-baseline assessment of response will be considered a non-responder.
  A secondary objective of this study is to evaluate the safety and tolerability of pazopanib in combination with paclitaxel in the treatment of subjects with advanced NSCLC. Safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), exposure, withdrawals due to AEs, dose reductions or interruptions, and changes from baseline in vital signs and clinical laboratory parameters.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of Stage IIIB (with confirmed malignant pleural effusion) or Stage IV NSCLC.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  -  No prior systemic first-line therapy for Stage IIIB/IV NSCLC with chemotherapy or any other biologic therapy. Prior surgery and/or localized irradiation for NSCLC are permitted. Palliative radiation therapy must have ended 14 days prior to first dose of pazopanib. Subject with recurrence after previous NSCLC that has been treated with surgery with or without adjuvant chemotherapy/radiation for curative intent are eligible, provided 12 months have passed since this treatment ended.
  Exclusion Criteria:
  -  Appropriate for doublet therapy as first line therapy. At discretion of investigator.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Summary: Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from Phase I/II studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.
  Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.
  We propose to conduct a study to determine how well water soluble iodinated contrast material when injected directly into the tumor can be visualized on CT scan and integrated into radiation therapy treatment planning.


Eligibility: Inclusion Criteria:- Either 1. Established primary lung cancer/ cancer metastatic to lung, OR 2. Lesion suspicious for malignancy in lung, according to the following criteria:
  A. Histopathologically confirmed lung cancer or cancer metastatic to lung, OR B. Plan for biopsy of suspicious lung mass based on imaging (growth on serial CT scan or nodule/mass with focal hypermetabolism on FDG-PET scan), OR C. Known metastatic cancer, with metastases to the lung based on imaging
  -  Age > 18 years old
  -  Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix IV)
  -  No prior surgery, chemotherapy, or radiation for the current lung tumor
  -  Both men and women and members of all races and ethnic groups are eligible for this trial.
  Exclusion Criteria:- Prior radiotherapy to thorax
  -  Allergy to iodine
  -  Contraindication to receiving radiotherapy, unless undergoing surgery
  -  Women who are pregnant

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation

Summary: The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

Detailed description: One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.
  During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

Eligibility: Inclusion Criteria:
  -  patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation
  Exclusion Criteria:
  -  patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure

Relevance to patient case: not relevant