araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Japanese BAY80-6946 Monotherapy Phase I Study

Summary: This study will be conducted as an open label, single centre, Phase I study of PI3K (phosphatidyl inositol 3 kinase) inhibitor BAY80-6946 in Japanese patients with advanced or refractory solid tumours. The eligible subjects will be dosed intravenously at Day 1, Day 8 and Day 15 with three weeks on and one week off in each treatment cycle.


Eligibility: Inclusion Criteria:
  -  Cancer patients
  -  Japanese patients, who are at least 20 years of age
  -  Histological or cytological documentation of non-hematologic, malignant solid tumours, excluding primary brain or spinal tumours, with no past or current involvement in the central nervous system (CNS)
  -  At least one measurable lesion or evaluable disease according to RECIST (version 1.1)
  -  Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1
  -  Life expectancy of at least 12 weeks
  -  Advanced or refractory solid tumours not amenable to standard therapy, at the first screening examination/visit
  Exclusion Criteria:
  -  Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia).
  -  Radiotherapy to target lesions during study or within 4 weeks of first study treatment
  -  Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment
  -  Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, and/or HbA1c>/= 6.5%
  -  Past and current histories of cardiac disease congestive heart failure > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
  -  Active and clinically serious infections >Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03)
  -  Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management
  -  Patients undergoing renal dialysis
  -  Pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

Summary: The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.

Detailed description: XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
  2. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
  3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
  4. ECOG Performance Status of 0 to 2
  5. Life expectancy of at least 3 months after registration
  6. Written informed consent
  7. Age of 20 to 74 years with either gender
  8. Adequate Major organ functions within 14 days before registration
  Exclusion Criteria:
  1. Positive HER2 status
  2. Previous history of fluoropyrimidines therapy within 6 months prior to registration
  3. Previous treatment with platinum agents
  4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
  5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
  6. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
  7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
  8. Active hepatitis
  9. Heart disease that is serious or requires hospitalization, or history of such disease within past year
  10. Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
  11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
  12. Chronic diarrhea (watery stool or ≥4 times/day)
  13. Active gastrointestinal bleeding
  14. Body cavity fluids requiring drainage or other treatment
  15. Clinical suspicion or previous history of metastasis to brain or meninges
  16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
  17. Unwillingness to practice contraception
  18. Poor oral intake
  19. Psychiatric disorders which are being or may need to be treated with psychotropics
  20. Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Summary: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Eligibility: Inclusion Criteria:
  -  any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

Summary: This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.

Detailed description: The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility: Inclusion Criteria:
  -  Recurrent endometrial carcinoma
  -  Disease progression following one or two lines of prior treatment with platinum containing chemotherapy
  -  Tumor tissue available at time of screening for PI3K analysis
  -  Adequate performance status
  -  Adequate glucose control, bone marrow, kidney, liver, and heart function
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemo regimens for endometrial carcinoma
  -  Prior therapy with an agent known to be a PI3K, and or mTOR and or AKT inhibitor
  -  Active brain metastases

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: A Phase I Study of E7050 in Subjects With Solid Tumors

Summary: The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.


Eligibility: Inclusion Criteria
  1. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
  2. Histological or cytological diagnosis of solid tumors.
  3. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
  4. Adequate organ function.
  5. Subjects who have no carryover of effect from prior therapy or no adverse drug reactions (excluding alopecia) that may affect the safety evaluation of the investigational drug.
  6. Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
  7. Expected to survive for 3 months or longer after starting administration of the investigational drug.
  Exclusion Criteria
  1. Females who are pregnant or breastfeeding.
  2. Brain metastases with clinical symptoms or which requires treatment.
  3. Serious complications or disease history.
  4. Subjects who cannot take oral medication.
  5. Using antiplatelet/anticoagulant drugs.
  6. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
  7. Scheduled for surgery during the study period.
  8. Known to be HIV, HBV or HCV positive.
  9. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years.
  10. History of drug or alcohol dependency or abuse within 2 years.
  11. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  12. Received any other investigational product or device within 4 weeks before administration.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Summary: This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.

Detailed description: This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Eligibility: Inclusion Criteria:
  -  Patient with palpable thyroid nodule suspicious for thyroid neoplasm
  -  Patient selected to undergo fine needle biopsy for cytologic diagnosis
  -  Male (18 years of age or older)
  -  Female (18 years of age or older)

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Summary: The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual post-marketing use.

Detailed description: Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Eligibility: Inclusion criteria:
  -  Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric ulcer
  -  Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for duodenal ulcer
  -  Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric MALT lymphoma
  -  Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for idiopathic thrombocytopenic purpura
  -  Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for early gastric cancer
  Exclusion Criteria:
  - H.pylori negative at the time when the triple therapy is started

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Summary: There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping.
  The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

Detailed description: Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.
  Laparoscopic SNNS:
  1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy
  2. Sentinel node basin identification and dissection
  3. Sentinel nodes picking in back table
  4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)
  5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed.
  Sample size: 100 cases
  Study duration: 5 years( 2year enrollment, 3 year follow-up)

Eligibility: Inclusion Criteria:
  -  Age 20-80
  -  Informed consent
  -  No other malignancies
  -  cT1N0 stage gastric cancers < 4cm
  -  no allergic history of isotope
  Exclusion Criteria:
  -  Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Genotype-drive Study of Irinotecan-Cisplatin Combination for Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.

Detailed description: Open label single arm phase II study of cisplatin and irinotecan in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 40 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 8 cycles/14 days of irinotecan 125 mg/m2 on Day 1 and cisplatin 50 mg/m2 on Day2. This study will also include genotype investigations of UGT1A1 and ERCC1 expression in order to assess determinants of efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.

Eligibility: Inclusion Criteria:
  -  Histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction)
  -  Stage III or Stage IV disease, according to American Joint Committee on Cancer criteria
  -  Patients with UGT1A1*28 genotype 6/6 or 6/7
  -  Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale
  -  Previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment
  -  Adequate organ function including the following:
  Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 10 g/dL.
  Hepatic: bilirubin < or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin > or equal to3g/dL.
  Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).
  Exclusion Criteria:
  -  No Prior palliative chemotherapy for advanced disease
  -  Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment
  -  Known or suspected brain metastasis
  -  Second primary malignancy

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

Summary: The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Detailed description: Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers.
  Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country.
  Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence.
  In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Eligibility: Inclusion Criteria:
  -  Histologically proven adenocarcinoma of stomach
  -  T3 or T4
  -  N1 or N2
  -  M0
  -  No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor.
  -  No involvement of the esophagus with > 2cm
  -  An age of 18-90 years
  -  A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
  -  No previous chemotherapy, radiotherapy for any malignancy.
  -  No previous surgery for gastric cancer
  -  No evidence obstructive or bleeding symptoms.
  -  Adequate renal and hepatic function
  -  Written informed consent
  Exclusion Criteria:
  -  Synchronous or metachronous malignancy diagnosing within 5 year
  -  Pregnancy or lactation in female patients
  -  Any immunosuppressive condition (acquired or iatrogenic)
  -  Any infectious toxic or mental condition preventing neoadjuvant therapy

Relevance to patient case: not relevant
Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Summary: This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.

Detailed description: Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer.
  Gastric cancer is the most frequent cancer in Korea.
  The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery.
  However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients.
  Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis.
  The incidence and adverse event will be examined to define the optimal prophylactic method of VTE in surgical patients with gastric cancer.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed as gastric cancer
  -  Elective and curative under general anesthesia
  -  ECOG score 0-2
  -  ASA score 3 or less than 3
  -  Informed consents
  Exclusion Criteria:
  -  2nd primary cancer
  -  VTE history within one year
  -  Anticoagulation history
  -  Allergic to heparin
  -  Pregnancy or expected pregnancy

Relevance to patient case: not relevant