araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Exocrine Pancreatic Function Testing in Cystic Fibrosis

Summary: Purpose The purpose of this study is to develop and validate multimodal testing of exocrine pancreatic function (EPF). The investigators will be testing exocrine pancreatic function in patients with cystic fibrosis (CF). Exocrine pancreatic function and imaging will be correlated to age group, genotype, nutritional status and quality of life. Earlier detection of exocrine pancreatic failure in the non classical form of cystic fibrosis may be of therapeutically benefit.
  Hypotheses Endoscopic short test can be applied in diagnosing and monitoring exocrine pancreatic function in patients with cystic fibrosis.
  New functional testing of exocrine pancreatic function is superior to traditional testing with fecal elastase.
  MRI and ultrasound methods can give volume output estimate in cystic fibrosis patients.
  Contrast enhanced ultrasound can quantify reduced or delayed pancreatic perfusion and parenchymal changes in cystic fibrosis patients.
  Elastography/ CEUS can be used in prediction and monitoring of fibrosis development and development of hepatocellular carcinoma in the liver of cystic fibrosis patients.
  Immunohistochemical quantification of secretin/ cholecystokinin (CCK) producing cell in duodenum can be utilized as a model hormonal signaling in cystic fibrosis patients with exocrine pancreatic function.

Detailed description: Study design: Observational, cohort studies.
  Patient characterization: Age, gender, and Genetic status from electronical records.
  Exocrine function testing (EPF): Secretin stimulated ultrasound and short endoscopic secretin test (EST). Faecal Elastase.
  Imaging: Transabdominal ultrasound of the liver and pancreas. secretin stimulated MRI. Contrast enhanced ultrasound (CEUS) of the pancreas using SonoVue contrast.
  Endpoints:
  Study 1: Exocrine pancreatic function by duodenal bicarbonate/ Enzymes related to Genetics and F elastase.
  Study 2: Ultrasound parenchymal changes of the pancreas related to Genetics and EPF.
  Study 3/4: Pancreatic secretion by ultrasound, MRI and EST related to EPF Study 5; Perfusion of the pancreas by CEUS related to EPF
  Study 6: Genotype-phenotype conciderations of the CF pancreas.

Eligibility: Inclusion Criteria:
  -  Diagnosis cystic fibrosis. Age over 15 years. Assigned to routine control at department of lung diseases, Haukeland university hospital.
  Exclusion Criteria:
  -  Unable to concent, allergies to Sonovue ultrasound contrast, pregnant or breastfeeding, contraindications against endoscopy.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Resectability of Pancreatic Head Cancer by Contrast-enhanced MDCT:a Multi-center Study

Summary: The purpose of this multicenter and double-blind clinical trial is to prospectively assess the sensitivity, specificity, negative predictive value, positive predictive value, and accuracy in respectability of pancreatic head cancer with contrasted-enhanced MDCT and its various post processing techniques, taking operational and pathological records as the gold standard.


Eligibility: Inclusion Criteria:
  -  Patients with (or suspected) pancreatic head cancer
  -  Being examined by contrasted-enhanced MDCT
  -  Receiving surgical treatment (including palliative surgery) in all research centers
  Exclusion Criteria:
  -  Patients having (or suspected) pregnancy or breast-feeding
  -  Patients having allergic reactions to iodinated contrast agents or Hypersensitivity reactions to allergens(including drugs)
  -  Patients receiving ERCP before contrasted-enhanced MDCT examination
  -  Patients without surgery because of a high degree of surgical risk

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Study to Evaluate the Efficacy and Safety of Simtuzumab Combined With Gemcitabine for Metastatic Pancreatic Adenocarcinoma

Summary: This study will compare the efficacy of simtuzumab (GS-6624) versus placebo in combination with gemcitabine in adults with pancreatic cancer. The treatment phase of this study will be comprised of 2 sequential parts: an open label treatment phase and a double-blinded treatment phase.


Eligibility: Inclusion Criteria:
  -  Initial diagnosis of metastatic pancreatic cancer must have occurred ≤6 weeks prior to the completion of screening.
  -  The presence of measurable metastatic pancreatic cancer documented by contrast enhanced CT (or MRI) scan in addition to 1 of the following:
  1. Histological diagnosis of pancreatic adenocarcinoma confirmed by pathologist OR
  2. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreatic origin in conjunction with either:
  1. The presence of a mass in the pancreas OR
  2. A history of resected pancreatic carcinoma
  -  Measurable disease per RECIST (ver. 1.1)
  -  ECOG Performance Status of 0 or 1.
  -  Adequate hepatic, hematologic and renal functions.
  Exclusion Criteria:
  -  A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas.
  -  A diagnosis of pancreatic islet neoplasms.
  -  Subject has undergone major surgery other than diagnosis surgery within 4 weeks of randomization
  -  Presence of biliary obstruction requiring external drainage
  -  Brain metastases.
  -  Unstable cardiovascular function within the last 6 months of screening
  -  Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
  -  Known HIV infection.
  -  Uncontrolled hypertension at Screening
  -  History or presence of any form of cancer, other than pancreatic cancer, within the 3 years prior to enrollment
  -  Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed.
  -  Uncontrolled systemic fungal, bacterial or viral infection
  -  Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma

Summary: The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.
  The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.


Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
  -  Patient eligible for chemotherapy treatment.
  -  Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
  -  ECOG performance status 0-2.
  -  A minimum age of 18 years old.
  Exclusion Criteria:
  -  Known to be HIV positive on antiretroviral therapy
  -  Prior organ allograft
  -  Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer

Summary: The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models the proteomic expression profile associated with exposure to Aurora and Polo-like kinase inhibitors. The identification of proteomic expression patterns in patients with NSCLC would be an important step in defining the possible role of these agents as potential targeted therapies for this clinically important disease. This study proposes to evaluate resected non-small cell lung cancer specimens for these proteomic expression profiles.


Eligibility: Inclusion Criteria:
  -  Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer
  -  Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
  -  Age ≥ 18 years.
  -  Subject meets criteria for thoracic surgery as determined by the thoracic surgeon.
  -  Able to provide written informed consent.
  Exclusion Criteria:
  -  Subjects undergoing or who have undergone thoracic surgery for metastatic disease from other primary sources such as colorectal cancer, sarcoma, melanoma, breast cancer, bladder cancer, prostate cancer, esophageal cancer, pancreatic cancer, or gastric cancer will be excluded.
  -  Subjects who have received prior preoperative lung cancer anticancer therapy will be excluded.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Summary: 1. Trial design: Prospective observational study
  2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
  3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
  -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
  4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
  5. Duration of Trial Recruitment: 2 years


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  19~80 year old male or female
  -  Histologically proven advanced or metastatic NSCLC
  -  Failed to 1st line chemotherapy
  -  Tumor tissue for genetic analysis
  -  Evaluable target lesion by RECIST v1.1
  -  ECOG performance from 0 to 3
  -  Expected survival more than 12 weeks
  Exclusion Criteria:
  -  Previous treatment of EGFR-tyrosine kinase inhibitors
  -  Severe hypersensitivity to erlotinib
  -  Residual toxicities (above grade 2) after previous chemotherapy
  -  Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer

Summary: The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.


Eligibility: Inclusion Criteria:
  -  Exocrine pancreatic adenocarcinoma cytologically or histologically confirmed
  -  Locally advanced and non-resectable with invasion of the superior mesenteric artery (stage III) or metastatic (stage IV) as defined by TNM 2002 classification (UICC 2002)
  -  resistant to a first or second line chemotherapy with gemcitabine
  -  Patient aged between 18 to 70 years
  -  Signed Informed Consent Form
  -  Life expectancy ≥ 12 weeks
  -  Accurate measurement of tumor volume by imagery (in at least one dimension)
  -  Presence of one or several tumor markers (CEA and CA 19.9)
  -  ECOG Prognostic Score : 0, 1 or 2
  -  Patient beneficiary of a Social Security Insurance
  Exclusion Criteria:
  -  Patient with an endocrine or acinar pancreatic tumor
  -  Patient with known or suspected cerebro-meningeal metastases
  -  Haemoglobin level greater than 13 g/L
  -  Patient hypersensitive to L-asparaginase or have had prior exposure to any form of L-asparaginase
  -  Splenic vein thrombosis < 3 months or under active treatment
  -  Anti-vitamin K treatment
  -  Hepatic Insufficiency unrelated to pancreatic cancer
  -  Renal insufficiency unrelated to pancreatic cancer
  -  Pancreatitis or pancreatitis history unrelated to pancreatic cancer
  -  Insulin-dependant diabetes mellitus unrelated to pancreatic cancer
  -  Current or prior coagulopathy disorders unrelated to pancreatic cancer
  -  ECOG Prognostic Score 3 or 4
  -  History of grade 3 blood transfusion reaction (life threatening situation)
  -  Presence of rare and dangerous anti-erythrocyte antibodies preventing from getting a compatible packed Red Blood Cells for the patient
  -  Patient already included in another clinical trial
  -  Pregnancy, breast-feeding or absence of secured contraception
  -  Unwillingness to sign the informed consent form

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Serum DCAMKL1 Pre and Post Treatment in Patients With Pancreatic Cancer

Summary: The investigators believe DCAMKL-1 is a stem cell tumor marker and is elevated in patients with pancreatic cancer. The investigators would like to analyze its expression pre and post treatment, to gauge the correlation between current pancreatic cancer therapies and the expression of DCAMKL-1


Eligibility: Inclusion Criteria:
  -  pancreatic cancer
  Exclusion Criteria:
  -  age < 18, history of other types of cancer

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Prospective Random Comparing Study on EUS-guided Pseudocyst Drainage by Naso-pancreatic Tube and Stents

Summary: EUS-guided pseudocyst drainage has been used world widely. Now, most endoscopists tend to place several stents to drain the content of cyst into GI tract. In the investigators experience, a modified naso-pancreatic tube drainage was more safer, easier and cheaper than placement of stents. Moreover, none of pseudocysts(total 19) drained by this modified naso-pancreatic tube drainage method were found recurrent with a follow up period from 3 months-34 months. So, the investigators designed this prospective random comparing study to confirm the result.


Eligibility: Inclusion Criteria:
  1. Adults with ages from 18-80 years old.
  2. The pseudocysts were formed more than 3 months.
  3. The size of pseudocyst is more than 5 cm.
  4. The patient has the symptoms related with the pseudocyst.
  5. The distance between gastric and the wall of the pseudocyst is less than 1 cm from CT image.
  6. The consent form has been signed.
  Exclusion Criteria:
  1. The patient can't accept the endoscopic procedure.
  2. The patient has blood coagulation dysfunction.
  3. The patient has mental disorders.
  4. The patient has mild or severe cardiorespiratory insufficiency.
  5. The patient has hypertension and can't be controlled to safe level.
  6. Diabetics whose blood sugar level can't be controlled to safe level.
  7. Patients with alcohol dependence
  8. Pregnant and lactating women.
  9. The patients the investigator don't think suitable for this study.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Summary: Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Detailed description: The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
  The inclusion criteria included:
  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.

Eligibility: Inclusion Criteria:
  1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  Exclusion Criteria:
  1. Patients receiving other anti-cancer drugs;
  2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
  3. Patient with inadequate Blood system,liver function and renal function.
  4. Brain metastasis is of symptoms
  5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
  6. Chronic enteritis or intestinal obstruction
  7. Bone marrow failure
  8. Mental disease difficult to control
  9. Participated other clinic trial within 3 months
  10. Pregnant or lactation patients
  11. The researcher evaluate the patient is not suitable for this trial.

Relevance to patient case: not relevant