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

Clinical trial: Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy

Summary: Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. Clinical study on postoperative feeding after pancreaticoduodenectomy is very limited. Method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
  1. To evaluate whether early enteral nutrition may be a suitable alternative to total parenteral nutrition
  2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy

Detailed description: Pancreaticoduodenectomy is associated with a high incidence of postoperative complications. These postoperative complications could delay postoperative resumption of adequate oral intake. The use of TPN significantly increases postoperative complications, especially those associate with infections. However, method of Nutritional support (Enteral feeding or total parenteral support)after pancreaticoduodenectomy is controversial.
  1. To evaluate whether early enteral nutrition may be decreased the postoperative complications
  2. To evaluate whether enteral feeding improve nutritional status after pancreaticoduodenectomy
  3. To determine the optimal method for postoperative nutritional support

Eligibility: Inclusion Criteria:
  -  Periampullar carcinoma
  -  Pancreaticoduonectomy
  -  KARNOFSKY PERFORMANCE SCALE > 70
  -  No history of Major operation
  Exclusion Criteria:
  -  Creatinine level>3mg/L
  -  Ascitis/portal hypertension
  -  New York Heart Association class>3
  -  COPD
  -  Preoperative Radiotheraly/chemotherapy
  -  Unresectable primary cancer
  -  Palliative surgery

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

Clinical trial: QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma

Summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease
  -  Mutant-type KRAS tumor at screening
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1
  -  Adequate hematology, renal, hepatic, and coagulation function
  Exclusion Criteria:
  -  History or known presence of central nervous system metastases
  -  History of other malignancy
  -  Prior irinotecan-based chemotherapy for advanced/metastatic disease
  -  Prior death receptor agonists, or other systemic IGF-1R agonists in any setting
  -  Uncontrolled cardiovascular disease

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

Clinical trial: PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
  -  Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  -  Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  -  Men or women 18 years of age or older
  -  Adequate hematologic, renal, hepatic, metabolic, and coagulation function
  Exclusion Criteria:
  -  History of prior or concurrent central nervous system (CNS) metastases
  -  Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  -  Clinically significant cardiac disease
  -  Clinically significant peripheral sensory neuropathy
  -  Active inflammatory bowel disease
  -  Recent gastroduodenal ulcer to be active or uncontrolled
  -  History of interstitial lung disease
  -  Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  -  Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  -  Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

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

Clinical trial: Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project

Summary: Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven colorectal cancer
  -  Unresectable stage IV disease
  -  K-Ras wild type tumour
  -  Patients scheduled to undergo chemotherapy with irinotecan and cetuximab
  Exclusion Criteria:
  -  Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
  -  Poorly controlled diabetes
  -  Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
  -  Symptomatic brain metastases
  -  Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception

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

Clinical trial: Reconstruction Following Pancreaticoduodenectomy: A Randomized Clinical Trial of Pancreaticojejunostomy vs Pancreaticogastomy

Summary: Pancreaticoduodenectomy (PD or Whipple procedure) involves the removal of the head of the pancreas and is the primary modality for treatment of peri-ampullary cancers (arising from the common bile duct, Ampulla of Vater, duodenum, neuroendocrine cells of the pancreas, and most commonly the exocrine pancreas). In Canada, cancer of the pancreas is the 11th cancer in terms of new cases/year, and the 5th leading cause of cancer related deaths/year. Following PD the remaining pancreas is re-connected to a portion of the gastrointestinal tract; the pancreas is very soft and difficult to sew and connect safely. The primary cause of complications following PD is related to leak occurring at this connection. Of patients that develop a leak, over half need a second operation, and up to 40% will die. The two main organs that the pancreas may be re-connected to are the jejunum or the stomach. The investigators will compare the rates of pancreatic leakage in two groups of patients randomized to reconnection to either the jejunum or stomach following PD. The goal of this study is to determine which of these methods is safer. The results may change practice patterns across North America and the world. It may in the future prevent many cases of avoidable leakage and the resulting morbidity of this including death. This will therefore reduce the morbidity and mortality of this group of cancer patients.


Eligibility: Inclusion Criteria:
  -  Suspected pancreatic or periampullary neoplasm that appears to be resectable based on preoperative imaging (CT scan and/or MRI) and are deemed medically fit to undergo PD.
  Exclusion Criteria:
  -  Patients less than 18 years of age will be excluded.
  -  As well, patients with distant metastasis, local unresectability, and/or gastric involvement will be excluded.
  Other exclusion criteria include:
  -  female subjects who are pregnant or nursing
  -  current use of an investigational drug
  -  currently receiving chemotherapy or radiotherapy.

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

Clinical trial: Endoscopic Ultrasound Staging of Periampullary Neoplasms: Retrospective

Summary: The purpose of this retrospective study is to determine the degree to which a biliary stent affects EUS staging accuracy of ampullary tumors.


Eligibility: Inclusion Criteria:
  -  Patients will be identified retrospectively through an existing Indiana University Medical Center EUS database and pathology database.
  -  Patients with and without biliary stents will be included.
  Exclusion Criteria:
  -  Patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.

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

Clinical trial: Comparison of AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive Non Small Cell Lung Cancer (NSCLC) Patients

Summary: The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
  -  Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
  -  Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).
  Exclusion Criteria:
  -  Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
  -  Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
  -  Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
  -  Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month

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 Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803

Summary: RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.

Detailed description: OBJECTIVES:
  -  To determine the association between polymorphisms in drug metabolizing enzymes and lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent prostate cancer receiving lapatinib ditosylate on clinical trial ECOG-E5803.
  -  To determine the association between mutations in EGFR, HER-2 and Kras; protein expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and progression-free survival.
  OUTLINE: Tissue and blood samples collected from patients enrolled on clinical trial ECOG-E5803 are analyzed for correlative studies. Samples are assessed for HER2, EGFR, MAPK, and Akt; EGFR mutations and polymorphisms in CYP3A4; Ras mutations; recently identified mutations in HER2-neu and Kras; and additional polymorphisms in the lapatinib ditosylate metabolic pathway by automated quantitative IHC. Predictors of efficacy and toxicity are analyzed, including markers in the EGFR pathway as predictors of progression-free survival.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of prostate cancer
  -  Recurrent disease
  -  Received lapatinib ditosylate on clinical trial ECOG-E5803
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Combination Study of BMS-754807 and Erbitux® in Subjects With Advanced or Metastatic Solid Tumors

Summary: The study is expected to identify a safe dose of BMS-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for Phase II studies. The study is also intended to collect first data on the effects of the combination of BMS-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective


Eligibility: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
  Inclusion Criteria:
  -  ECOG status 0 - 1
  -  Dose escalation: Subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. Colorectal cancer subjects must be confirmed KRAS wild type
  -  Dose expansion: CRC (KRAS-WT) and head & neck cancer subjects only
  1. must be able to provide 2 fresh tumor biopsy samples
  2. must have failed one prior cetuximab-containing treatment
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Prior treatments with anti-EGFR (except cetuximab) or anti-IGF-1R agents, experimental or licensed
  -  Any condition requiring chronic use of steroids
  -  Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms)
  -  History of glucose intolerance
  -  History of cetuximab infusion reactions
  -  Women of child-bearing potential unwilling or unable to use acceptable contraception methods

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

Clinical trial: Vitamin K-absorption From Dairy

Summary: Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Eligibility: Inclusion Criteria:
  -  Healthy men and women between 20 and 45 years old
  -  Subjects of normal body weight and height according to BMI < 30
  -  Subjects of Caucasian race
  -  Subject has given written consent to take part in the study
  Exclusion Criteria:
  -  Subjects with (a history of) metabolic or gastrointestinal disease
  -  Subjects presenting chronic degenerative and/or inflammatory disease
  -  Abuse of drugs and/or alcohol
  -  Subjects receiving corticoid treatment
  -  Subjects using oral anticoagulants

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

Clinical trial: 4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

Summary: The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.


Eligibility: Main Inclusion Criteria:
  -  Advanced stage hepatocellular carcinoma
  -  Patients exhibiting progressive disease under Sorafenib treatment
  -  Child-Pugh class A and B. Only patients with Child-Pugh index class B of not more than 7 will be included
  -  ECOG performance status 0, 1 or 2
  -  Precedent first-line treatment with Sorafenib minimum continuous dosing of 400 mg per day for at least 8 weeks
  Main Exclusion Criteria:
  -  Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) - any cancer curatively treated > 3 years prior to entry is permitted
  -  Renal failure requiring hemo- or peritoneal dialysis
  -  Known central nervous system (CNS) tumors including symptomatic brain metastasis
  -  Child-Pugh index class B in combination with more than slight ascites or hepatic encephalopathy > Grade I
  -  Pregnant or breastfeeding women
  -  Sorafenib intolerance
  -  Major surgery within the last 4 weeks

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

Clinical trial: Epidemiologic Study of KRAS Mutation in Brazilian Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Summary: The purpose of this study is to characterize the demographic and clinical aspects, and describe the frequency and type of KRAS mutation in a Brazilian population sample with advanced non-small cell lung cancer (NSCLC).


Eligibility: Inclusion Criteria:
  -  Histological or cytological confirmation of locally advanced or metastatic Non Small Cell Lung Cancer (IIIB-IV)
  -  Tumour sample (block of slides) available for KRAS analysis
  Exclusion Criteria:
  -  Confirmation of locally advanced or metastatic NSCLC (IIIB-IV) exclusively by cytology, with no tumour sample access.
  -  Previous treatment using a MEK inhibitor or any other regimen containing docetaxel (previous treatment with paclitaxel is accepted)

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

Clinical trial: Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Summary: The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.


Eligibility: Inclusion Criteria:
  -  Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
  -  Bile duct or gallbladder cancer invading CBD or distal CHD
  -  Pancreatic cancer with mid or distal CBD invasion
  -  Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
  -  First attempt of endoscopic biliary metallic stenting
  -  Negative history of biliary tract surgery
  -  Life expectancy at least longer than 4 months (Karnofsky score >60%)
  Exclusion Criteria:
  -  Ampullary cancer
  -  Klatskin tumor
  -  Combined intrahepatic bile duct cancer
  -  Patient with hemobilia
  -  Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days

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

Clinical trial: Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients

Summary: This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.

Detailed description: This is an observational, prospective, non-interventional, single arm, non-comparative, open label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects: 1500. Demographic information, complete medical history and tumour history related data will be captured in the first visit and if any information is missing, then only another visit will be scheduled. Data captured will be analysed and presented using statistical tools.
  OBJECTIVES:
  Primary objective:
  -  To record the prevalence of KRAS mutations in the Argentine mCRC population.
  Secondary objective:
  -  To record and evaluate certain subject and tumour characteristics for association with KRAS mutational status (country, gender, age, performance status, body mass index (BMI), ethnic origin, personal and family history of malignancy, personal and family history of familial polyposis coli, smoking status, exercise, diet, tumour characteristics/location, site of origin of the tissue sample sent for KRAS testing, first line therapy chosen).

Eligibility: Inclusion Criteria:
  -  Subjects who have signed written informed consent before any study-related procedure
  -  Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1
  -  Subjects with age above 21 years
  -  Subjects willing to provide information required by protocol
  -  No previous systemic treatment for mCRC
  Exclusion Criteria:
  -  Subjects with known pregnancy
  -  Subjects with previous systemic therapy for mCRC
  -  Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study
  -  Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent

Relevance to patient case: not relevant