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

Clinical trial: A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Summary: This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.


Eligibility: Inclusion Criteria:
  -  Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
  -  Measurable disease as determined by RECIST 1.1
  Exclusion Criteria:
  -  Primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions
  -  Clinically significant cardiac disease or impaired cardiac function

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 in Patients With Head and Neck Cancer

Summary: RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
  -  To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.
  OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Eligibility: DISEASE CHARACTERISTICS:
  -  Treated on protocol ECOG-E5397
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Pharmacogenomic Study (Adjuvant Chemotherapy)

Summary: To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.
  To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.


Eligibility: Inclusion Criteria:
  -  gastric cancer patients treated with adjuvant chemotherapy
  Exclusion Criteria:

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 Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

Summary: Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:
  1. ME-NBI is useful in distinguishing EGC from other gastric lesions
  2. ME-NBI is useful in further differential diagnosis among EGCs.


Eligibility: Inclusion Criteria:
  -  patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
  Exclusion Criteria:
  -  advanced gastric cancer or any other malignancy;
  -  patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
  -  inability to provide informed consent;
  -  inability to provide histology of resected specimens after endoscopic treatment or surgery.

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

Clinical trial: Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

Summary: The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.

Detailed description: The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.
  With respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.
  Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.
  So far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors.

Eligibility: Inclusion Criteria:
  -  H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer
  -  Gastric tumor is completely removed through endoscopic resection.
  Exclusion Criteria:
  -  Patients underwent gastrectomy before enrollment
  -  patients underwent endoscopic resection before enrollment
  -  Previous history of eradication for H. pylori
  -  Pregnancy
  -  Aged <20 yr old or aged >75 yr old
  -  Patients underwent additional gastrectomy due to incomplete endoscopic resection

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

Clinical trial: Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

Summary: Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.


Eligibility: Inclusion Criteria:
  -  ≥ 18 and ≤ 70 years of age
  -  Histological confirmed advanced or metastatic adenocarcinoma of the stomach
  -  Have failed for at least 2 lines of chemotherapy
  -  Life expectancy of at least 12 weeks.
  -  Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
  -  At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
  -  Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
  -  More than 4 weeks for operation or radiotherapy
  -  More than 4 weeks for cytotoxic agents or growth inhibitors
  -  Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin < 1.25× ULN, and serum transaminase ≤ 2.5× ULN).
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
  -  Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
  -  Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
  -  International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
  -  Abuse of alcohol or drugs
  -  Certain possibility of gastric or intestine hemorrhage
  -  Less than 4 weeks from the last clinical trial
  -  Prior VEGFR inhibitor treatment
  -  Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.

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 Gastric Cancer Foundation: A Gastric Cancer Registry

Summary: The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer via an online questionnaire with genomic data obtained from blood and tissue samples. The purpose of this registry is to gain better understanding of the causes of gastric cancer, both environmental and genetic; whether certain genomic data can predict outcomes of treatment and survival; as well as explore the issues that effect the quality of life of these patients after diagnosis and treatment.

Detailed description: Collect detailed clinical and epidemiological information on patients with gastric tumors via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood sample and paraffin block samples from previous surgery.

Eligibility: Inclusion Criteria:
  1. Patients are eligible if they have a histologically proven gastric tumor including gastroesophageal tumors
  2. 18 years of age or older
  3. Adequate English proficiency to complete online consent and questionnaire.
  Exclusion Criteria:
  1. Under 18 years of age
  2. No history of gastric cancer or gastric cancer in a family member.

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

Clinical trial: Perioperative Chemotherapy for Potentially Resectable Gastric Cancer

Summary: Stage I：Neoadjuvant therapy
  -  Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to surgery alone;Capecitabine plus oxaliplatin is non-inferiority to Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
  Stage II: Perioperative therapy
  -  Perioperative Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin is superior to adjuvant Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin alone;Capecitabine plus oxaliplatin regimen is noninferiority to Tegafur,Gimeracil and Oteracil Potassium Capsules plus oxaliplatin
  -  A regimen of Tegafur，Gimeracil and Oteracil Potassium Capsules plus oxaliplatin(SOX) and Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic gastric cancer. The investigators assessed whether the addition of a perioperative regimen of SOX or XELOX regimen to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced gastric cancer.


Eligibility: Inclusion Criteria:
  -  Age 18 -75
  -  Histologically or cytologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction)
  -  ECOG performance status ≦2
  -  Tumor stage T3/4NxM0
  -  No distant metastasis (M0)
  Exclusion Criteria:
  -  History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product
  -  Inadequate hematopoietic function： WBC≦4,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3
  -  Inadequate organ function which is defined as below:
  Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 1.2 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);
  -  Symptomatic peripheral neuropathy
  -  Receiving a concomitant treatment with other fluoropyrimidines
  -  Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method.
  -  Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication:
  -  Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
  -  History of ventricular arrhythmia or congestive heart failure.
  -  Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary fibrosis, heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes.

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

Clinical trial: Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Summary: There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.

Detailed description: In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up >3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;

Eligibility: Inclusion Criteria:
  -  Follow-up period > 3 years,
  -  weight stable in the last year
  Exclusion Criteria:
  -  Reoperation or take-down of original operation,
  -  consumptive diseases,
  -  protein-calorie malnutrition,
  -  organ failures,
  -  pancreatic surgery,
  -  cell or organ transplantation,
  -  type 1 diabetes,
  -  cognitive impairment or Alzheimer disease,
  -  refusal to participate in the protocol

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

Clinical trial: Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes

Summary: Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.

Detailed description: Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.

Eligibility: Inclusion Criteria:
  1. Diagnosed with Type 2 diabetes
  2. Diagnosed with gastric cancer
  Exclusion Criteria:
  1. Type 1 diabetes
  2. Unresectable cancers

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

Clinical trial: Qualitative Research for Stage 4 Stomach Cancer and Their Caregivers

Summary: Find A Cure Panel is looking for people with Stage 4 stomach/gastric cancer or the caregivers of people with Stage 4 stomach/gastric cancer to participate in anonymous and qualitative research that will take an estimated 60 minutes of your time.
  This is opinion based, experiential research and is NOT a drug trial.
  Note that Stage IV is also known as "advance disease" or metastatic stomach/gastric cancer.
  If you are interested in participating, please email FACP at: info@findacurepanel.com


Eligibility: Inclusion Criteria:stage 4 stomach cancer patients and caregivers -
  Exclusion Criteria:loved one must still be living

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

Clinical trial: Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

Summary: The purpose of this study is to evaluate the safety and the effect of perioperative chemotherapy in the treatment of advanced gastric cancer.

Detailed description: To evaluate the security and the relapse-free survival time/rate(1,2,3 yrs) of perioperative chemotherapy with ECX (epirubicin + cisplatin + capecitabine) and XP (capecitabine + cisplatin）in advanced gastric cancer

Eligibility: Inclusion Criteria:
  -  Male and female aged 18 to 70 years old.
  -  The preoperative evaluation: gastric cancer patients, ≥ T2 or N +; or staging II, IIIA, IIIB.
  -  Karnofsky score ≥ 70, life expectancy > 6 months.
  -  Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma, leiomyosarcoma and other mesenchymal tumors.
  -  the blood and biochemical indicators of the subjects must meet the following criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3; GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the upper limit of normal, serum creatinine< 1.25 times the upper limit of normal and creatinine clearance rate ≥ 60ml/min, LVEF ≥ 60%.
  -  have not received prior chemotherapy, radiotherapy and biological therapy.
  -  signed informed consent.
  -  must accept the standard D2 or D2 + radical gastrectomy.
  -  with good compliance.
  Exclusion Criteria:
  -  pregnancy, breast-feeding women.
  -  allergy with chemotherapy drugs or metabolic disorder.
  -  the history of organ transplants (including bone marrow transplantation and autologous peripheral stem cell transplantation).
  -  had long received systemic steroid treatment (Note: short-term users of withdrawal > 2 weeks can be selected.)
  -  The existence of the peripheral nervous system disorders or significant neurological disorders and a history of central nervous system disorders.
  -  patients with severe infection requires treatment.
  -  patients associated with dysphagia, active peptic ulcer, incompleteness intestinal obstruction, active gastrointestinal bleeding, perforation.
  -  severe liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrollable diabetes.
  -  with other malignancies which were not cured.
  -  EKG abnormalities or heart disease with apparent clinical symptoms, including congestive heart failure, coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction. Coronary heart disease with symptoms, uncontrollable arrhythmia, hypertension, and heart attack within 12 months or III or IV grade myocardial infarction.

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 Diagnosis of Biliary Tract Neoplasm by Diffusion Weighted Imaging and Magnetic Resonance Cholangiopancreatography

Summary: Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

Detailed description: The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases.People with suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis.Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.

Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（＞37U/mL）
  -  No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
  -  Age ≥ 16
  Exclusion Criteria:
  -  Previous Biliary Tract Neoplasm surgery
  -  Contraindication for MRI (such as pacemaker or inner ear implant)
  -  Claustrophobia
  -  Age < 16

Relevance to patient case: not relevant