araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation

Summary: The purpose of this study is to determine the value of novel non-invasive medical imaging methods for detecting the spread of head and neck squamous cell carcinoma to the lymph nodes in the neck by comparing their results to findings at the time of surgery.


Eligibility: Inclusion Criteria:- Adult patients with newly diagnosed (biopsy-proven), untreated squamous cell carcinoma (SCC) of the head and neck who will undergo neck dissection as part of primary surgical therapy.
  Exclusion Criteria:- A prior adverse reaction to the contrast/tracer agents being used in the imaging methods being studied.
  - Pregnancy.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours

Summary: Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer [18]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.

Detailed description: The proposed clinical trial will be a Phase I/II imaging, open label, single site study. In Phase I, one 18F-FAZA PET scan will be conducted in patients with known squamous cell carcinoma of the Head & Neck, SCLC, NSCLC, lymphoma, GGM, neuroendocrine tumours or renal cell carcinoma. In Phase II, three 18F-FAZA PET scans will be done on patients with the above tumours as follows: one pre-treatment, one mid course and one post-treatment.

Eligibility: Inclusion Criteria:
  -  Male or female greater than or equal to 16 years of age.
  -  If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  -  Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion >1 cm in diameter.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Alimta, Carboplatin and Radiation Therapy for Non Small Cell Lung Cancer

Summary: To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer

Detailed description: To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.
  To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.

Eligibility: Inclusion Criteria:
  -  Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions
  Exclusion Criteria:
  -  Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Randomized Trial of Fluticasone in Bronchial Premalignancy

Summary: The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

Detailed description: Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. The purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of >10 pack-years and patients cured of head and neck cancer or lung cancer. Participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. After 6 months, biopsies are taken from the same locations. Efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and hTERT expression.

Eligibility: Inclusion Criteria:
  -  signed informed consent
  -  age over 18
  -  metaplasia index > 15%
  -  over 25 pack years smoking history or history of lung- or head&neck cancer
  -  male/female of non-childbearing potential or using approved contraception
  Exclusion Criteria:
  -  use of inhaled/systemic corticosteroid drugs in the preceding 12 months
  -  contraindications for bronchoscopy/use of fluticasone
  -  major illness
  -  Baseline FEV1<1000ml
  -  Previous participation in clinical study
  -  nodules > 1cm on CT

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

Summary: The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Detailed description: This is a modified phase I Single arm, open, non randomized trial of NGR-hTNF in advanced solid tumors for the definition of an optimal biological

Eligibility: Inclusion Criteria:
  -  Patients >18 years old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. Tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included.
  -  ECOG Performance status 0 - 2
  -  Patients may have had prior therapy providing the following conditions are met:
  -  Chemo, radio, hormonal or immunotherapy: wash-out period of 28 days
  -  Surgery: wash-out period of 14 days
  -  Adequate baseline bone marrow, hepatic and renal function, defined as follows:
  -  Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
  -  Bilirubin < 1.5 x ULN
  -  AST and/or ALT < 2.5 x ULN in absence of liver metastases
  -  AST and/or ALT < 5 x ULN in presence of liver metastases
  -  Serum creatinine < 1.5 x ULN
  -  Absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "Technical data sheet human albumin")
  -  Normal cardiac function and absence of uncontrolled hypertension
  -  Patients must give written informed consent to participate in the study
  Exclusion Criteria:
  -  Concurrent anticancer therapy
  -  Patients may not receive any other investigational agents while on study
  -  Clinical signs of CNS involvement
  -  Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  -  Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
  -  Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  -  Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Summary: The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.


Eligibility: Inclusion Criteria:
  -  Man or woman at least 18 years old.
  -  Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
  -  Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
  -  Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
  -  Measurable and non-measurable disease.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  Exclusion Criteria:
  -  History or known presence of Central Nervous System (CNS) metastases.
  -  History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
  -  Nasopharyngeal carcinoma.
  -  Prior systemic treatment for metastatic and/or recurrent SCCHN
  -  Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
  -  Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
  -  Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
  -  Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Summary: Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.

Detailed description: Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement

Eligibility: Inclusion Criteria:
  -  Patients with histological confirmation of non-small-cell lung carcinoma.
  -  Complete surgical resection of the disease.
  -  Tumoral tissue available for molecular analysis.
  -  N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
  -  Men or women age 18 years or older.
  -  Patients with a performance status of 2 or less according to the ECOG classification.
  -  Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
  -  Complete recovery from surgery within 6 weeks.
  -  Patients who have given written informed consent before initiating any specific study screening procedure.
  Exclusion Criteria:
  -  Patients who have received previously chemotherapy or radiotherapy for the study disease.
  -  Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
  -  Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
  -  Women who are pregnant or in the period of lactation.
  -  Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
  -  Patients under treatment with investigational agents.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease

Summary: The purpose of this protocol is to obtain biologic samples from the blood and lungs from patients with lung diseases in order to study the causes and indications of these disorders, learn how these lung disease manifest and progress, and how the lung disease can be treated.

Detailed description: The lung diseases are disorders associated with functional and/or structural derangements to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this protocol is to obtain biologic materials from the blood and lungs from these patients in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other protocols such as those involving investigational new drugs. As such, this protocol is part of the "infrastructure" for all of our human lung-related studies such as genomic/gene expression studies of airway epithelium and alveolar macrophages in all individuals with chronic obstructive lung disease (COPD), asthma, bronchogenic carcinoma, and pulmonary fibrosis compared to normal non-smokers and smokers, and studies of mediators in bronchoalveolar lavage fluid.
  This protocol, to be carried out at Weill Cornell Medical College - Qatar and Hamad Medical Corporation, Qatar, parallels a similar approved protocol IRB #0005004440, entitled, "Evaluation of the Lungs of Individuals with Lung Disease with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy", ongoing at Weill Cornell Medical College - New York.

Eligibility: Inclusion Criteria:
  Inclusion/Exclusion criteria for Part A
  -  Must provide informed consent
  -  Males and females, age 18 years and older
  -  Evidence of lung disease by at least one of the following:
  1. symptoms consistent with pulmonary disease;
  2. chest X-rays and/or chest CT consistent with lung disease;
  3. pulmonary function tests consistent with lung disease;
  4. lung biopsy consistent with lung disease;
  5. family history of lung disease;
  6. diseases of organs with known association with lung disease; and
  7. individuals suspected of having lung disease based on history and/or physical examination
  -  Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care
  Exclusion Criteria:
  -  Patient refuses consent.
  Patients enrolled in Part A of the protocol will not undergo screening procedures/tests. These patients are undergoing a fiberoptic bronchoscopy as dictated by their standard clinical care and additional samples will be taken for research purposes.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

Summary: The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer [SCLC])
  -  Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
  -  Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  -  Accessible for treatment and follow-up
  Exclusion Criteria:
  -  Brain metastases
  -  Malignant pleural effusion
  -  Autoimmune disease
  -  Motor neuropathy of autoimmune origin
  -  SCLC-related paraneoplastic syndromes
  -  Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
  -  Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
  -  Grade 2 peripheral neuropathy (motor or sensory)
  -  Known HIV or hepatitis B or C infection
  -  Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
  -  Inadequate hematologic function defined by an absolute neutrophil count <1,500/mm^3, a platelet count <100,000/mm^3, or hemoglobin level <9 g/dL.
  -  Inadequate hepatic function defined by a total bilirubin level >2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
  -  Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
  -  Inadequate creatinine clearance defined as less than 50 mL/min.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors. This compound is also an inhibitor of the anaplastic lymphoma kinase (called ALK) tyrosine kinase and ROS receptor tyrosine kinases. This research study is the first time PF-02341066 will be given to people. PF-02341066 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced malignancies (except leukemias), histologically proven at diagnosis; Histologically confirmed advanced malignancies that are known to be sensitive to PF-03241066 inhibition, e.g. ALK, c-MET and ROS
  -  Solid tumors must have measurable disease (Recommended Phase 2 Dose Cohort patients with non-measurable disease may enter on a case-by-case basis); not required for DDI sub-studies.
  -  Adequate blood cell counts, kidney function, liver function and Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 (for the Recommended Phase 2 Cohort, a ECOG score of 2 may be allowed on a case-by-case basis)
  Exclusion Criteria:
  -  Major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort
  -  Prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma
  -  Active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Relevance to patient case: definitely relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: GliaSite 1-3 Mets Study

Summary: This study has been designed to compile information on the efficacy of the GliaSite RTS combined with radiosurgery in the treatment of newly diagnosed metastatic brain tumors.

Detailed description: Data relevant to the evaluation the effectiveness of the GliaSite RTS for a resected dominant brain metastases will be collected. The GliaSite RTS is a radionuclide applicator and liquid radionuclide (Iotrex) designed to deliver intracavitary radiation therapy for resected brain tumors. In this case, it will irradiate the resected margins. Brain metastases not surgically removed will be then treated with radiosurgery

Eligibility: Inclusion Criteria:
  -  Have 1-3 newly diagnosed supratentorial metastatic brain lesions with at least one being dominant and eligible for surgical resection as visualized on enhanced MRI scan
  -  Have histological evidence of metastatic carcinoma on intraoperative pathology (frozen section) or final pathology report
  -  Have a Karnofsky Performance Status (KPS) >=70
  -  Have systemic disease which is judged to be stable and has been staged within the last 6 weeks
  -  Have a life expectancy of >= 6 month, based upon extent of systemic disease
  -  Be at least 18 years of age Give informed consent (or have legal representative give informed consent)
  Exclusion Criteria:
  -  Be receiving or have plans to receive conventional or investigational systemic agents for the metastatic brain tumor.
  -  Be receiving or have plans to receive external beam radiation therapy to the brain.
  -  Have received prior conventional or investigational systemic agents, including the use of Gliadel Wafers or Temodar, for the treatment of the brain metastasis.
  -  Be pregnant or breast-feeding.
  -  Have uncontrolled hypertension, unstable angina pectoris, evidence of uncontrolled cardiac dysrhythmia.
  -  Have other serious concurrent infection or other medical illness which would jeopardize the ability of the patient to safely undergo resection and brachytherapy.
  -  Have histology of lymphoma or small-cell lung cancer.

Relevance to patient case: not relevant
Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

Clinical trial: Saliva mRNA Expression Profiling for Early Stage Non-Small Cell Lung Cancer Screening

Summary: This is a pilot study to test the feasibility of using gene expression from saliva to identify patients with early-stage non-small cell lung cancer (NSCLC).
  The primary objective of this study is to compare gene expression profiles from saliva from healthy controls and patients with early-stage non-small cell lung cancer.
  To be eligible, patients with non-small cell lung cancer, must not yet have received treatment for their cancer (surgical removal, chemotherapy, or radiation therapy). Health control participants may participate if they meet eligibility criteria listed below.
  Eligible enrollees will be asked to submit a one time saliva sample and complete a study questionaire.


Eligibility: Inclusion Criteria:
  1. Patients with untreated stage I-II NSCLC OR Healthy control subjects: with a > 20 pack year history of cigarette smoking OR Never smokers (defined as less than 100 cigarettes over subject's lifetime)
  -  The investigators recognize that pathologic confirmation is not always available prior to surgical resection of a lung mass. To account for this, subjects with a suspicious lung mass concerning for lung cancer, can be enrolled on this trial, and submit a saliva sample prior to surgical resection (ideally within 45 days of planned surgery).
  2. Adults age 40-79
  3. Ability to understand the investigational nature of the study and sign the informed consent in accordance with institutional and FDA guidelines
  Exclusion Criteria:
  1. No active pulmonary infection, i.e. bronchitis or pneumonia for 6 months
  2. No use of steroid inhalers for > 6 months
  3. No other prior malignancy is allowed except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancers from which the patient has been disease-free for 5 years

Relevance to patient case: not relevant