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

Clinical trial: The Oncopanel Pilot (TOP) Study

Summary: The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.
  The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

Detailed description: Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.
  Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.

Eligibility: Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:
  -  Advanced colorectal cancer and eligible for standard KRAS testing,
  -  Advanced non-small cell lung cancer and eligible for standard EGFR testing,
  -  Advanced melanoma and eligible for standard BRAF testing,
  -  Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
  -  Being considered for potential eligibility in clinical trial.

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

Clinical trial: S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy

Summary: After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).


Eligibility: Inclusion Criteria:
  -  Patients who voluntarily provide written informed consent prior to entering into this study
  -  Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
  -  Patients who underwent radical resection with wide lymph node dissection
  -  TNM stage (6th AJCC) of IIIB or IV on post-operative staging
  -  Patients who can be randomized within 6 weeks after surgery
  Exclusion Criteria:
  -  Aged < 20 years or ≥ 76 years
  -  Eastern Cooperative Oncology Group (ECOG) performance status >2
  -  Patients who underwent surgery for neoplasm in stomach in the past
  -  History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
  -  Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
  -  Residual cancer on post-operative staging (R1 and R2 resection)
  -  Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
  -  Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
  -  Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
  -  Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
  -  History of hypersensitivity to the investigational products (S1 and Oxaliplatin)

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

Clinical trial: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Summary: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
  1. Main purpose
  1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
  2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
  2. Secondary purpose
  1. To observe tumor clinical benefit rate (CR+PR+SD).
  2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility: Inclusion Criteria:
  -  Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  -  Failed routine chemotherapy
  -  Neoplasms can be evaluated by imaging
  -  ECOG《2
  Exclusion Criteria:
  -  Have systematic chemotherapy in 2 weeks
  -  Be allergic to ultrasonic microbubbles and chemotherapeutics
  -  Uncontrolled high blood pressure, cardiovascular disease
  -  Active bleeding
  -  Have serious mental and psychological disease

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

Clinical trial: Non-Interventional Study of Xeloda (Capecitabine) in Patients With Gastric Cancer

Summary: This observational study will collect prospective data on the safety and tolerability of Xeloda in patients with advanced gastric cancer from every day clinical practice. Documentation of treatment for each patient is to continue until the end of treatment per oncologist's assessment.


Eligibility: Inclusion Criteria:
  -  Patients aged >/=18 years, with metastatic gastric cancer who are available for prospective documentation of their treatment (first-line chemotherapy)
  -  Informed consent
  Exclusion Criteria:
  -  Contraindications to Xeloda per the Summary of Product Characteristics (SmPC)

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 II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

Summary: To investigate the anti-tumor activity of single agent BYL719, INC280, LDK378 and MEK162


Eligibility: Inclusion Criteria:
  -  Advanced (stage IIIB or stage IV) NSCLC
  -  Must have specific molecular alterations
  Exclusion Criteria:
  -  Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 4 weeks prior to study entry to control their CNS disease
  -  Radiation therapy within ≤ 4 weeks prior to study entry, with the exception of limited field palliative radiotherapy for bone pain relief.
  -  Any other malignancies within the last 5 years before study entry
  -  Major surgery ≤ 2 weeks prior to study entry or who have not recovered from side effects of such therapy
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: NGS Genome Analysis in Personalisation of Lung Cancer Treatment

Summary: The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.
  Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.


Eligibility: Inclusion Criteria:
  -  patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  -  Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  -  man and women
  -  age ≥ 18 years
  -  Patients have signed a written informed consent form
  -  Patients are affiliated to s social health insurance
  Exclusion Criteria:
  -  Survival time ≤ 3 months
  -  Patients with cerebral metastases
  -  Patients could not benefit from treatment for others diseases
  -  Pregnancy or breast-feeding
  -  Incapacity to sign the consent form for psychiatric, behavioural disorders
  -  Private individuals of freedom or under tutelage

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

Clinical trial: Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

Summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the ATU.


Eligibility: Inclusion Criteria:
  -  The participant has histologically or cytologically confirmed gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) after prior chemotherapy.
  -  Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-fluorouracil (5-FU) and capecitabine). Prior trastuzumab use in human epidermal growth factor receptor 2 positive (HER2+) participants is accepted too.
  -  The participant is eligible for treatment by chemotherapy and has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  Exclusion Criteria:
  -  Participant has a known allergy to any of the treatment components.

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

Clinical trial: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors

Summary: This is a three-part, open-label, safety, tolerability, and PK study of FPA144. Patients will be enrolled in Part 1 (A or B, dose escalation) or Part 2 (dose expansion) of the study, but not both.

Detailed description: Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted. Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients.
  Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment.

Eligibility: Inclusion Criteria:
  -  Life expectancy of at least 3 months
  -  ECOG performance status of 0 to 1
  -  Adequate hematological and organ function, confirmed by lab values
  -  Tumor tissue for determination of FGFR2b overexpression and FGFR2 amplification (optional for Part 1A patients)
  Exclusion Criteria:
  -  QTc segment >470 msec
  -  Treatment with any anticancer therapy or investigational drugs </=14 days (</=28 days for patients in Korea) prior to first dose of FPA144
  -  Presence of any condition that may increase the risk associated with study participation or interfere with interpretation of study results

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 TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer

Summary: The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.


Eligibility: Key Inclusion Criteria:
  -  Patients who are diagnosed as gastric cancer.
  -  No prior treatment for gastric cancer.
  -  Negative or unknown for HER2 testing.
  -  ECOG performance status of 0 or 1.
  Key Exclusion Criteria:
  -  Unmanageable diarrhea.
  -  Current peripheral sensory neuropathy or paresthesia.
  -  Pregnant or lactating female.

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

Clinical trial: Prognosis and Risk Factors of Gastric Cancer in Patients With Intestinal Metaplasia

Summary: This prospective cohort study aims to assess the incidence of gastric cancer in patients with intestinal metaplasia in body of stomach or angular incisure.
  As secondary objectives, among the patients included in the cohort, the study will:
  -  assess the incidence of low grade dysplasia,
  -  assess the incidence of high grade dysplasia in patients with low grade dysplasia,
  -  identify risk factors of progression to dysplasia and gastric cancer.

Detailed description: This is a French nationwide prospective study. 2000 patients will be enrolled by 3500 gastroenterologists, either in private or public healthcare settings.
  All patients will undergo an endoscopy with gastric sampling in order to biopsy:
  -  1 sample each in anterior and posterior surfaces of antrum
  -  1 sample in lesser curvature
  -  1 sample each in anterior and posterior surfaces of body of stomach
  Patients will be contacted every 12 months and followed up for 3 years by their gastroenterologist. The follow-up will be performed according to the 2012 European Guideline on Management of Precancerous Conditions and Lesions in the stomach (Endoscopy 2012, Jan; 44(1): 74-94). Patients will also receive a 6-monthly phone call from their gastroenterologist in order to know if any gastric symptom has appeared. At any time, patients should contact their gastroenterologist to inform them about new gastric symptoms.
  During follow-up, the frequency of gastroscopy with biopsy depends on the stage of lesions:
  -  patients with intestinal metaplasia: gastroscopy at 36 months.
  -  patients with dysplasia: an annual gastroscopy will be performed.
  In case of low grade dysplasia confirmed by pathologist at inclusion, patients will undergo 1 year later another endoscopy with gastric sampling in order to biopsy:
  -  4 circumferential samplings of antrum
  -  1 sampling of curvature
  -  4 circumferential samplings of body of stomach

Eligibility: Inclusion Criteria:
  -  Age > 18 years.
  -  Gastroscopic examination with biopsy in the 6 months preceding inclusion, with intestinal metaplasia in body of stomach or angular incisure.
  -  Patient does not oppose to participate to the study.
  Exclusion Criteria:
  -  Progressive concomitant disease with life expectancy less than 3 years.
  -  Gastric cancer at the time of inclusion.
  -  Patient with previous oesophageal cancer.
  -  Patient with previous gastric surgery.
  -  Anticipated obstacles to follow-up during the study (e.g., understanding difficulties, homelessness).

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

Clinical trial: Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer

Summary: The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？

Detailed description: Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.

Eligibility: Inclusion Criteria:
  -  cT1a：ulcer（+）and lesion diameter>3cm and differentiated type. Any ulcer and lesion diameter d>2cm and poorly differentiated type.
  -  cT1b: Submucosal injection (+)
  Exclusion Criteria:
  -  metastasis
  -  recrudescence

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

Clinical trial: Comparison of Delta-Shaped and Billroth II After TLDG

Summary: To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

Detailed description: Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Eligibility: Inclusion Criteria:
  -  carcinoma located in the lower 1/3 of gastric body or antrum of stomach
  -  diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan
  -  diameter of the tumor <3cm
  -  no pyloric obstruction
  Exclusion Criteria:
  -  diameter of the tumor ≥3cm
  -  associated with obstruction, bleeding, emergency surgery or surgical intervention
  -  tumor with extensive metastasis
  -  patient had previously undergone gastrostomy

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 With Herceptin For Potentially Resectable HER-2 Positive Gastric Cancer With Liver Metastasis

Summary: Stage I：preoperative therapy
  -  Capecitabine plus oxaliplatin with herceptin is superior to surgery alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis; Stage II: Perioperative therapy
  -  Perioperative Capecitabine plus oxaliplatin with herceptin is superior to adjuvant Capecitabine plus oxaliplatin alone for patients with potentially resectable HER-2 positive gastric cancer with liver metastasis;

Detailed description: The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with herceptin to improves R0 resection rate and survival among patients with potentially resectable HER-2 positive gastric cancer with liver metastasis.

Eligibility: Inclusion Criteria:
  -  1.Pathological tissue were gastric cancer by gastric and liver biopsy.
  2.Immunohistochemistry confirmed HER-2 (+)or FISH(+).
  3.gastric cancer with liver metastasis were not able to resectable lesions.
  4.Patients•had not received radiotherapy past and not other organ metastasis and peritoneal metastasis.
  5.ECOG performance status 0-1.
  6.Inadequate hematopoietic function： Hemoglobin≥90g/L; ANC≥1,500/mm3;Platelet≥100,000/mm3 7.Inadequate organ function which is defined as below: Total bilirubin≤1.5 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≤1.5 pper limit of normal range (ULN), Serum albumin≥30g/L.
  8.expectancy must be more than 3 months. 9.the random blood or urine pregnancy test in fertile woman must be the negative results in pregnancy test in 7 days.
  10.Patients for male and female used reliable contraception contraceptive method until the end of study 30 days later.
  11.The operation can complete the D2 operation(LNM≥15).
  12.LVEF≥50%
  Exclusion Criteria:
  -  1. Patients with other extrahepatic metastasis Include peritoneal metastasis.
  3. Patients with other malignancy in 5 years.
  4. Patients with peripheral nerve disease,two hydrogen pyrimidine dehydrogenase( DPD )deficiency,upper digestive tract obstruction or from malabsorption syndrome.
  5.Patients with hypertension failed to control, active bleeding, 3~4 proteinuria, heal the wound, romboembolism, heart failure, clinical symptoms of heart disease.
  6.Patients have obvious peripheral nervous system disorders,mental disorders and disorders of the central nervous system history.
  7.Patients have history of organ transplantation.
  8.Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
  9.Patients combined antitumor drug outside the research program.

Relevance to patient case: not relevant