araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

Summary: Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility: Inclusion Criteria:
  -  Adult (age more than 19)
  -  Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
  -  Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer
  Exclusion Criteria:
  -  Patient who denied clinical trial
  -  Diabetes Mellitus(DM) patient with DM complication
  -  Hyperlipidemia patient with vascular co-morbidity
  -  Impaired renal function or renal failure (GFP<90%)

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Summary: This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Detailed description: Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure.
  Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

Eligibility: Inclusion Criteria:
  -  Patients with clinically suspected/confirmed CBDS
  -  CBD caliber 5-15 mm
  Exclusion Criteria:
  -  History of bile duct surgery
  -  History of bile duct tumor
  -  History of bile duct stricture
  -  Severe comorbidity
  -  Unstable vital signs
  -  Pregnancy
  -  Coagulopathy

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Study of LXH254 and LTT462 in NSCLC

Summary: To characterize safety and tolerability of LXH254 and LTT462 combination and identify a recommended dose and regimen.


Eligibility: Inclusion Criteria:
  -  Patients must have advanced or metastatic NSCLC
  -  Presence of KRAS or BRAF mutation in tumor tissue
  -  All patients participating in this clinical trial must have progressed following standard therapy or, in the opinion of the Investigator, no effective standard therapy exists, is tolerated, appropriate or is considered equivalent to study treatment.
  -  ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
  Exclusion Criteria:
  -  Dose expansion - Group 1: Prior treatment with a RAFi (including any BRAFi and pan-RAFi), MEKi and/or ERKi. Group 2: Prior treatment with an ERKi and/or a pan-RAFi.
  -  History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
  -  Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
  -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
  -  Patients with Gilbert's syndrome or other heritable diseases of bile processing.
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma positive EBUS-TBNA specimen
  Exclusion Criteria:
  -  other diagnosis

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Tumor Characteristics, Pre-transplant Treatments and Immunosuppression After Liver Transplantation for Hepatocellular Carcinoma

Summary: Recurrence after liver transplantation for hepatocellular carcinoma (HCC) represents an important cause of mortality for this surgical population. In addition to tumor characteristics, It has been suggested that pre-treatment and sirolimus-based immunosuppression may affect recurrence and survival. With data from the European Liver Transplant Registry (ELTR) database, the aim of this study is to investigate the impact of tumor characteristics, pre-transplant treatment and immunosuppression regimens on survival after liver transplantation for HCC.


Eligibility: Inclusion Criteria:
  -  Hepatocellular carcinoma within transplantation criteria
  Exclusion Criteria:
  -  Disseminated disease

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Percutaneous Microwave Ablation Under Ultrasound Guidance for Liver Cancer: a Multicenter Analysis

Summary: Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. This study is designed to investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA as a primary treatment will be enrolled from at least ten Chinese institutions with different levels of MWA experience. All the patients will be closely followed up until June 2019. Clinicopathologic data, recurrence and survival estimates, complications and prognosis-relative factors will be measured.


Eligibility: Inclusion Criteria:
  -  absence of ascites or the depth of ascites on US detection less than 4 cm;
  -  a normal serum total bilirubin level or less than 60 µmol/L;
  -  a normal albumin level or not less than 30 g/L;
  -  for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
  -  for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
  Exclusion Criteria:
  Contraindications include patients who have
  1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state;
  2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L);
  3. high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden;
  4. acute or active inflammatory and infectious lesions at any organ;
  5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction;
  6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma

Summary: Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.
  Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.


Eligibility: Inclusion Criteria:
  -  The sex of the subject is not limited, the age is from 18 to 70 years old;
  -  Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
  -  Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
  -  Karnofsky score ≥ 80 points;
  -  No evidence of distant metastasis;
  -  Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.
  Exclusion Criteria:
  -  The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
  -  Previously received immunotherapy;
  -  Previously received chemotherapy;
  -  Previously received radiation therapy;
  -  Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
  -  Evidence of distant metastases or other malignancies at the same time.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: A Study of Varlitinib in Japanese Subjects With Advanced or Metastatic Solid Tumours

Summary: The purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in Japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in Japanese subjects with advanced or metastatic biliary tract cancer. Also to evaluate pharmacokinetics (PK) of varlitinib, capecitabine and its metabolite.


Eligibility: Inclusion Criteria:
  -  Study I: Subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage
  -  Study II: Subjects with advanced (unresectable) or metastatic biliary tract cancer (IHCC, EHCC, gallbladder cancer or ampullary carcinoma)
  Exclusion Criteria:
  -  Subjects with concurrent multiple primary cancers.
  -  Subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease
  -  Subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Central Obesity and Hepatocellular Carcinoma

Summary: Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.
  In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.


Eligibility: Inclusion Criteria:
  -  absence of ascites or the depth of ascites on US detection less than 4 cm;
  -  a normal serum total bilirubin level or less than 60 µmol/L;
  -  a normal albumin level or not less than 30 g/L;
  -  for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
  -  for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.
  Exclusion Criteria:
  1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
  2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
  3. high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
  4. acute or active inflammatory and infectious lesions at any organ
  5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
  6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Summary: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Detailed description: This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Eligibility: DISEASE CHARACTERISTICS:
  Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
  Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
  Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
  No lymphomas or neuroendocrine tumors.
  No peritoneal carcinomatosis.
  PRIOR/CONCURRENT THERAPY:
  Biologic Therapy: More than 4 weeks since immunotherapy.
  Chemotherapy:
  No prior chemotherapy for newly diagnosed disease.
  More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
  Endocrine Therapy: More than 4 weeks since hormonal therapy.
  Radiotherapy:
  No prior radiotherapy for newly diagnosed disease.
  No prior abdominal or pelvic radiotherapy.
  More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
  Surgery:
  Prior resection allowed.
  Biliary decompression or gastric bypass allowed.
  PATIENT CHARACTERISTICS:
  Age: 18 and over.
  Performance status: ECOG 0-2.
  Hematopoietic:
  ANC greater than 2,000/mm(3).
  Platelets greater than 100,000/mm(3).
  Hepatic: AST/ALT no greater than 2.5 times normal.
  Renal:
  Creatinine less than 1.5 mg/dL.
  Creatinine clearance at least 60 mL/min,
  Cardiovascular:
  No myocardial infarction within 6 months.
  No unstable angina.
  No congestive heart failure (NYHA class III/IV).
  OTHER:
  HIV seronegative.
  No medical or psychiatric contraindication to protocol therapy.
  No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
  No pregnant or nursing women.
  Adequate contraception required of fertile patients.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer

Summary: RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer.
  PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed.

Detailed description: OBJECTIVES: I. Study the safety of autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) in patients with resected pancreatic adenocarcinoma. II. Examine the immune response to HSPPC-96 in this group of patients.
  OUTLINE: This is a dose escalation study. Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) subcutaneously once a week for 4 weeks. Five patients are initially enrolled at each of two dose levels. An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96. Patients are followed at weeks 1, 4, and 12 after treatment.
  PROJECTED ACCRUAL: A maximum of 16 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS: Histologically proven, resected, stage I or II pancreatic adenocarcinoma
  PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Lymphocyte count at least 700/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No clinically significant heart disease Other: No other serious illness No active infections requiring antibiotics within past 2 weeks Not pregnant or nursing Fertile patients must use effective birth control No known immunodeficiency No active bleeding
  PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiation therapy Surgery: Must undergo Whipple procedure or distal pancreatectomy at Memorial Hospital Must not have undergone splenectomy Other: No investigational treatment within 2 months of surgery No immunosuppressive therapies

Relevance to patient case: not relevant