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

Clinical trial: Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

Summary: Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed description: There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.
  However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.
  The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Eligibility: Inclusion Criteria:
  -  Elective surgery
  -  American Society of Anesthesiologists (ASA) scores < 3
  -  20 < Age < 80
  -  Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
  -  Informed consent
  -  No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
  -  No systemic inflammatory disease
  Exclusion Criteria:
  -  Emergency operation

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 Substitution of 5-FU (Fluorouracil) by Capecitabine in Scheme of Chemo-radiotherapy in Patients With Squamous Cell Carcinoma of the Anal Canal.

Summary: The squamous cell carcinoma (SCC) of the anal canal is an uncommon neoplasia which corresponds to 1-5% of intestinal tumors. However the risk of SCC of the anal canal has been growing recently. The standard treatment of anal cancer stage II-III is multimodal and consists of combined chemotherapy (infusional 5-fluorouracil and mitomycin) and radiotherapy. This scheme currently used was proposed in 1974, and since then no other effective treatment has been developed.
  The purpose of this study is to determine the efficacy and toxicity of the combination of capecitabine and mitomycin with radiotherapy in patients with carcinoma of the anal canal. For this will be selected 51 patients to be treated with chemo-radiotherapy.
  The primary endpoint will be local control rate after 6 months of the end of radiotherapy and chemotherapy, defined by the rate of radiological and clinical neoplasia.


Eligibility: Inclusion Criteria:
  -  Invasive anal canal SCC histologically confirmed, T2-4 N0 M0, T (anyone) N1-3 M0 - according to TNM staging system.
  -  Age ≥ 18 years.
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
  -  Adequate medullar function, defined as: Absolute neutrophil count ≥ 1,5×109/L; platelets ≥100×109/L; hemoglobin ≥10g/dl.
  -  Serum AST (aspartato aminotransferase) and ALT (alanine aminotransferase) < 3 × ULN (upper limit of normal).
  -  Serum Creatinine ≤ 1,5 ULN and clearance of creatinine estimated (Cockcroft- Gault) ≥ 50 ml/min.
  -  Signed written informed consent.
  Exclusion Criteria:
  -  Major surgical procedure within 4 weeks of the beginning of the treatment.
  -  History of severe systemic or psychiatric disease.
  -  Previous treatment for anal canal carcinoma or other cancer.
  -  For female patients, current pregnancy and/or lactation
  -  Unstable angina or acute myocardial infarction within 6 months.
  -  Concomitant use of oral anticoagulants
  -  HIV positive with result of CD4 ≤ 200.
  -  Previously pelvic radiotherapy.

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 Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer

Summary: Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.


Eligibility: Inclusion Criteria:
  -  Age, between 19 and 75
  -  Histologically proven advanced gastric cancer
  -  R0 resection after D2 gastrectomy
  -  Stage III (according to the AJCC 7th criteria)
  -  ECOG status 0 to 2
  Exclusion Criteria:
  -  Malignancy history other than gastric cancer
  -  Previous chemotherapy history for gastric cancer
  -  Previous radiotherapy history for gastric cancer
  -  Pregnancy or breast milk feeding
  -  Grade 3 or more of neuropathy
  -  Active infection
  -  Severe hepatic dysfunction
  -  Severe renal dysfunction
  -  Severe bone marrow dysfunction
  -  Significant neurologic or psychologic disease
  -  Inadequate condition for receiving chemotherapy due to significant systemic disease
  -  Patients who receives drugs which can be interacted with S-1

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

Clinical trial: Functional Jejunal Interposition Improve Nutritional Status After Total Gastrectomy

Summary: The purpose of this study is to find out whether the nutritional status of patients undergoing Functional Jejunal Interposition is better than those with Roux-en-Y After Total Gastrectomy for Gastric Cancer. To find a better reconstruction for patients who received total gastrectomy.

Detailed description: Surgery is the only curative way for gastric cancer to date. Methods of Resection and reconstruction are closely related to prognosis and nutritional status. Therefore, it is essential to choose. At present, more and more clinical centers tend to choose Roux-en-Y (RY) reconstruction after total gastrectomy, which are prone to a variety of complications, and seriously affects the quality of life, such as malnutrition. There is argument over whether functional jejunal interposition is better than those with Roux-en-Y After total gastrectomy for gastric cancer. How to improve the nutritional status of the patients following total gastrectomy with gastrointestinal reconstruction arouses people's attention. The purpose of this study was to evaluate differences of the nutritional status in patients undergoing functional jejunal interposition and Roux-en-Y after total gastrectomy.

Eligibility: Inclusion Criteria:
  -  Untreated patients with curative resectable gastric cancer (A)a clear pathological diagnosis (B)the surgeon and radiologist assess the possibility of removal (C)no previous history of other malignancies. (D)the patient has signed an informed consent form (E)cardiopulmonary and kidney function is normal (F)ECOG body condition scores 0 to 1 (G)does not require emergency surgery
  Exclusion Criteria:
  - (A) pregnant or lactating women; (B) of the liver, lung, bone, and other distant metastasis; (C) positive supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc.; (D) massive ascites, cachexia; (E) with other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poor merger control hypertension, diabetes; (F) mental disorder or disease; (G) 4 weeks prior to enrollment participated or are participating in other clinical trials of patients; (H) had undergone surgery, and its influence has not been eliminated for patients; (I) a history of stomach or esophagus cancer, including stromal tumors, sarcoma, lymphoma, carcinoid; (J) combined with active infection in patients (infection caused by fever above 38 ℃); (K) in patients with poor compliance or poor patient compliance investigators to consider; (L) Some researchers believe that other clinical, laboratory conditions patients should not participate in the 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: Intraductal Papillary Mucinous Neoplasm With Malignant Change

Summary: Purpose:
  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012.
  Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

Detailed description: 1. Purpose
  -  To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
  2. Enroll criteria
  -  Patient who is suspected to have pancreas IPMN on imaging
  -  Interval between imaging study and surgery is less than 2 months
  -  Who is scheduled for surgery due to IPMN

Eligibility: Inclusion Criteria:
  -  Patients who is suspected to have IPMN by imaging study or clinician
  -  Time interval between imaging study and surgery less than 2 months
  Exclusion Criteria:
  -  Patients who have pathology results not by surgery
  -  Who is less than 20 years old
  -  Who cannot voluntarily agree study design

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

Clinical trial: Omentectomy in Radical Gastrectomy for Gastric Cancer Trial

Summary: In patients with gastric cancer, traditionally a complete omentectomy is performed as part of a radical gastrectomy with a modified D2 lymph node dissection. The omentectomy increases operation time significantly, especially in laparoscopic procedures. Patients remain more vulnerable for peritoneal infections and intestinal adhesions following omentectomy. Furthermore one can debate whether a complete omentectomy is indicated from an oncologic viewpoint. In the present study we prospectively evaluated the presence of tumor load in the greater omentum of patients with potentially curative gastric cancer.


Eligibility: Inclusion Criteria:
  -  an in potentially curative gastric cancer
  -  age > 18 year
  Exclusion Criteria:
  -  palliative resection
  -  age < 18 year

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

Clinical trial: Intracorporeal Versus Extracorporeal Roux-en-Y Esophagojejunostomy During Laparoscopic Total Gastrectomy for Gastric Cancer

Summary: -  To date, Roux-en-Y esophagojejunostomy transabdominal extracorporeally by circular stapler was the most common used method during laparoscopy-assisted total gastrectomy for gastric cancer, even though it was not totally laparoscopic surgery in which intracorporeal anastomosis should be performed.
  -  To gain potential clinical benefits from a smaller length of minilaparotomy and an easier anastomosis technique than extracorporeal anastomosis, intracorporeal Roux-en-Y anastomosis using a transorally inserted anvil (OrVil™) during totally laparoscopic total gastrectomy was adopted by experienced surgeons recently.
  -  However, the safety of intracorporeal Roux-en-Y esophagojejunostomy using a transorally inserted anvil (OrVil™) has not yet been evaluated. Thus, the study comparing the safety of intracorporeal versus extracorporeal Roux-en-Y esophagojejunostomy by circular stapler based on a well designed randomized controlled trial is needed.


Eligibility: Inclusion Criteria:
  -  Age from over 18 to under 75 years
  -  Primary gastric adenocarcinoma confirmed pathologically by endoscopic biopsy
  -  Tumor located at middle or upper third of stomach while laparoscopic total gastrectomy is the planning surgery
  -  Tumor invasion is less than 3cm above the esophagogastric junction
  -  Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  -  ASA (American Society of Anesthesiology) score class I, II, or III
  -  Written informed consent
  Exclusion Criteria:
  -  Women during pregnancy or breast-feeding
  -  Severe mental disorder
  -  History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  -  Conversion to open surgery before reconstruction

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

Clinical trial: Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

Summary: The purpose of this trial is to explore the clinical utility of the three investigational agents in HR+, HER2- breast cancer. LEE011 (CDK4/6 inhibitor), BKM120 (PI3K-pan class I-inhibitor) and BYL719 (PI3K-alpha specific class I inhibitor) in combination with fulvestrant.
  This is a multi-center, open-label Phase Ib/II study. The Phase Ib portion of the study is a dose escalation to estimate the MTD and/or RP2D for three regimens: LEE011 with fulvestrant; LEE011 and BKM120 with fulvestrant; LEE011and BYL719 with fulvestrant.
  The Phase II portion of the study will be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant, and LEE011 and BYL719 with fulvestrant in patients with ER+/HER2- locally advanced or metastatic breast cancer.
  Approximately 216 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.


Eligibility: Inclusion Criteria:
  -  Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer
  -  Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting (Phase Ib)
  -  Unlimited number of lines of endocrine therapy and one line of cytotoxic chemotherapy in the metastatic setting (Phase II)
  Exclusion Criteria:
  -  HER2-overexpression in the patient's tumor tissue
  -  Inadequate bone marrow function or evidence of end-organ damage
  -  Severe or uncontrolled medical issues
  -  Diabetes mellitus
  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: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

Summary: Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear.
  Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield.
  Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy.
  Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.


Eligibility: Inclusion Criteria:
  -  Age equal to or above 18 years
  -  Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
  -  Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
  -  Surgical resectable (T1-3, N0-1, M0)
  -  Informed consent
  Exclusion Criteria:
  -  Previous or coexisting cancer
  -  Previous surgery of the stomach
  -  ASA classification (American Society of Anaesthesiologists) score 4 or higher

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

Clinical trial: Copanlisib Pharmacodynamic Study

Summary: This study aims to analyze what the study drug does to the body and its relationship to drug levels and safety after patients with advanced cancer have been treated with copanlisib in different dose groups.


Eligibility: -  Histologically confirmed diagnosis of the following NHL: follicular lymphoma all grades, lymphoplasmacytic lymphoma / Waldenström macroglobulinemia, transformed indolent lymphoma, diffuse large B-cell lymphoma, Burkitt lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma, relapsed or refractory, with 1 or more prior chemo-immunotherapy- or immunotherapy-based regimen(s) OR
  -  Advanced and / or refractory solid tumors with high prevalence (≥30%) of PIK3CA or PTEN alteration: Breast and uterine cancers (endometrium cancers but also non-endometrial uterine cancers), lung (squamous cell only), cervical, head and neck, prostate, and ovarian cancers
  -  Biopsy-accessible tumor
  -  Male or female patients equal 18 or more years of age
  -  NHL patients must have at least 1 bi-dimensionally measurable lesion according to the modified Cheson criteria. Patients with solid tumors must have at least 1 solid tumor lesion measurable by computed tomography or magnetic resonance imaging according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria
  -  Eastern Cooperative Oncology Group performance status 2 or <
  -  Life expectancy of at least 3 months
  -  Adequate bone marrow, liver, and renal functions as assessed by laboratory requirements conducted within 7 days before the first dose of study drug
  -  Left ventricular ejection fraction > or equal the lower limit of normal for the institution
  Exclusion Criteria:
  -  Previous or concurrent cancer that is distinct in primary site or histology from NHL or the solid tumor, for which the patient is enrolled into this study, within 5 years before treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, in situ breast cancer, in situ prostate carcinoma if Gleason score < or equal to 6 and prostate-specific antigen <10 ng/mL, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]
  -  Known lymphomatous involvement of the brain or leptomeningeal involvement; solid tumor patients with central nervous system (CNS) metastases if treatment completed <3 months before enrollment or lesions unstable or progressing on magnetic resonance imaging scans performed within 1 month of enrollment or unstable symptoms of the CNS metastases
  -  Any illness or medical condition that is unstable or could jeopardize the safety of the patient or his / her compliance in the study
  -  Current diagnosis of type 1 or type 2 diabetes mellitus with HbA1c < or equal to 8.5% or fasting blood glucose < or equal to 160 mg/dL

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

Clinical trial: DNA Methylation Biomarkers and Metastasis of Gastric Carcinoma

Summary: Gastric carcinoma (GC) is the second leading cause of cancer death throughout the world. In previous multi-center study, we have found that the prevalence of GDNF family receptor alpha 1(GFRA1), serum response factor (SRF), and ZNF382 methylation alterations were inversely and coordinately associated with GC metastasis and the patients' overall survival throughout discovery and testing cohorts in China, Japan and Korea. The present cohort study is to investigate whether methylation of those genes can predict the metastasis and prognosis of GC.

Detailed description: Background: Metastasis is the leading cause of death for gastric carcinoma (GC). Currently, GC prognosis is primarily determined based on the clinical data and pathological stages of patients at the time of diagnosis and treatment. However, successful management of GC patients is still hampered by lack of highly sensitive and specific biomarkers capable of predicting prognosis and likelihood of metastasis. GFRA1 hypomethylation along with SRF and ZNF382 hypermethylation were found to be potential synergistic biomarkers for the prediction of GC metastasis in our previous multi-center study. In addition, p16 and E-cadherin were also correlated with GC metastasis in Chinese cohort. To investigate the predictive value of those genes' methylation on metastasis potential in GC, we carried out the prospective cohort study.
  Methods: 198 early stage GC patients without lymph node or distal metastasis were included in the present study. Baseline information of E-cadherin, GFRA1, p16, SRF and ZNF382 methylation status of the GC from 191 cases was obtained by MethyLight. The follow-up examination was carried out in a double-blind study with a 6-month interval. The association between gene methylation and metastasis of GC was analyzed with SPSS16.0 software. All P-values were two-sided.

Eligibility: Inclusion Criteria:
  -  Histological diagnosis of gastric adenocarcinoma;
  -  Early stage GC without lymph node and distal metastasis;
  -  Availability of frozen, fresh GC and corresponding surgical margin samples;
  -  Available of methylation status of gene CpG island in the extracted DNA sample.
  Exclusion Criteria:
  -  GC with lymph node or distal metastasis;
  -  Quality of the prepared DNA is not good enough for detection of gene methylation;
  -  GC cases were subjected to the neoadjuvant chemotherapy.

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

Clinical trial: Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study

Summary: To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.


Eligibility: Inclusion Criteria:
  -  Participation in previous study (NCT01559779)
  Exclusion Criteria:
  -  Pregnancy/lactation
  -  Major chronic disease develop since previous examination with possible impact on outcomes

Relevance to patient case: not relevant