araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Feasibility of Obtaining and Characterizing Circulating Tumorigenic Cells in Patients With Pancreatic Adenocarcinoma

Summary: The purpose of this study is to collect blood samples and study cancer cells found in these blood samples from patients with pancreatic cancer. Prior research has discovered that tumor cells can be collected from the blood of patients with pancreatic and other cancers.
  The physicians have developed techniques for isolating and analyzing cancer cells using a simple blood test. They will study how these cells relate to how chemotherapy works. They hope to use this information to guide choices of treatment for patients in the future.


Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC.
  -  Patient eligible for chemotherapy treatment.
  -  Prior surgery, chemotherapy and/or radiation therapy for pancreatic adenocarcinoma is permitted.
  -  ECOG performance status 0-2.
  -  A minimum age of 18 years old.
  Exclusion Criteria:
  -  Known to be HIV positive on antiretroviral therapy
  -  Prior organ allograft
  -  Any medical or psychiatric condition that may interfere with the ability to comply with protocol procedures

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Efficacy and Safety of Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Summary: This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS mutant colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Metastatic Colorectal Carcinoma with KRAS mutation.
  -  Received first line therapy and discontinued part or all of first line therapy.
  -  Estimated life expectancy > 3 months.
  -  Stage IV disease.
  -  Eastern Cooperative Oncology Group (ECOG) 0-2.
  -  Adequate hepatic and hematologic function
  -  No major operations within 4 weeks prior to treatment start.
  Exclusion Criteria:
  -  More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
  -  Experimental medical treatment within 30 days prior to study entry.
  -  Known or suspected cerebral metastases.
  -  History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment.
  -  Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).
  -  Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia.
  -  Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
  -  Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis.
  -  Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
  -  Prior irinotecan therapy for metastatic disease is not permitted.
  -  Systemic fungal, bacterial, viral, or other infection.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients

Summary: This phase Ib study includes two phases: dose escalation phase and safety expansion phase.
  During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients.
  During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced or metastatic pancreatic adenocarcinoma that have not been previously treated or have progressed despite chemotherapy
  -  Performance status of 0 or 1 per WHO classification
  -  Adequate hematologic , renal and liver function
  -  Adequate blood creatine kinase value (CK < 1.5ULN)
  Exclusion Criteria:
  -  Treatment with prior radiotherapy
  -  Pancreatic cancer that is potentially curable by surgery
  -  Women of childbearing potential unless they are using highly effective method of contraception Other protocol-defined inclusion/exclusion criteria may apply
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Interest of Saline MR Peritoneography for Pre-operative Assessment of Rectal Cancer

Summary: MR saline peritoneography could be useful to demonstrate the peritoneal outline of the pouch of Douglas. The investigators think that the localization of the rectal tumor in function of this anatomic mark could be decisive for pre-operative assessment.


Eligibility: Inclusion Criteria:
  -  Rectal adenocarcinoma
  Exclusion Criteria:
  -  Metastatic disease
  -  under 18y patient
  -  woman of childbearing age

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic Adenocarcinoma

Summary: This is an open-label, single centre, single-arm phase II study which aims to assess the efficacy and tolerability of triplet combination of capecitabine, oxaliplatin and irinotecan (Xeloxiri regimen) in treating patients with advanced unresectable pancreatic carcinoma. Clinical data from patients diagnosed with pancreatic adenocarcinoma will be collected and analyzed in this study. The patients' data will be collected and maintained in the Division of Medical Oncology of the University Department of Medicine, Queen Mary Hospital, Hong Kong.


Eligibility: Inclusion Criteria:
  -  Adults ≥ 18 years of age, male or female.
  -  Histopathologically or cytologically confirmed adenocarcinoma of the pancreas.
  -  ECOG performance status 0 to 2.
  -  Adequate bone marrow reserve.
  -  Absolute neutrophil count > 1x10^9/L.
  -  Total bilirubin <3 times the upper limit of the normal range.
  -  Life expectancy ≥ 12 weeks.
  -  Signed written informed consent form.
  Exclusion Criteria:
  -  Prior malignant disease other than pancreatic cancer.
  -  Patients suitable for surgical or locoregional therapies.
  -  Patients who have prior anticancer therapy for pancreatic cancer.
  -  Patients unable to swallow oral medications.
  -  Any evidence of brain metastasis (unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
  -  Active clinically serious infections (> grade 2 NCI / CTC Adverse Event version 3.0).
  -  History of allergy to platinum compounds.
  -  Patients who have chronic inflammatory bowel disease and/or bowel obstruction.
  -  Patients who have severe bone marrow failure.
  -  Patients undergoing renal dialysis.
  -  History of HIV infection.
  -  Seizure disorder requiring medication (such as steroids or anti-epileptics).
  -  Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception.
  -  Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

Summary: This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part.
  Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.
  Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.


Eligibility: Inclusion Criteria:
  -  Patients aged ≥ 18 years
  -  Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.
  -  Patients must have relapsed or progressed following standard therapy or patients for whom no standard anticancer therapy exists.
  -  Measurable disease as determined by RECIST v1.1. World Health Organization (WHO) Performance Status (PS) ≤ 2.
  -  Adequate organ function
  -  Negative serum pregnancy test
  Exclusion Criteria:
  -  Prior therapy with MEK- or IGF-1R- inhibitor
  -  History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or retinal degenerative disease
  -  Patients with known history of severe infusion reactions to monoclonal antibodies
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  History of thromboembolic event requiring full-dose anticoagulation therapy
  -  Clinically significant cardiac disease
  -  History of another malignancy within 2 years
  -  Pregnant or nursing (lactating) women
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: definitely relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers

Summary: This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).


Eligibility: Inclusion Criteria (AD group):
  -  Greater than 50 years of age
  -  Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  -  Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
  -  History of cognitive decline gradual in onset and progressive over a period of at least 6 months
  Inclusion Criteria (healthy volunteer group):
  -  35 to 55 years of age, inclusive
  -  MMSE of 29 or greater
  Exclusion Criteria (both groups):
  -  Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
  -  Diagnosis of other dementing / neurodegenerative disease
  -  Diagnosis of mixed dementia
  -  Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
  -  Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
  -  Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
  -  Clinically significant psychiatric disease
  -  History of epilepsy or convulsions
  -  Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  -  Current clinically significant cardiovascular disease
  -  Received investigational medication within the last 30 days

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Summary: Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.
  The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility: Inclusion Criteria:
  -  The patients diagnosed as biliary tact adenocarcinoma.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Summary: Depression and anxiety accompany with advanced cancer. The effect of anti-anxiety depression has not evaluated in special cancers. Mirtazapine is a drug anti-anxiety depression and has a high risk increase weight. So the investigators assume Mirtazapine would not only improve the anxiety and depression of metastasis pancreas cancer but also would improve the appetite of such patients which would improve dyscrasia of pancreas cancer patients. The drug may improve the quality of life in advanced pancreatic cancer which is of short survival.

Detailed description: The investigators design a phase II/III trial to compared Mirtazapine plus gemcitabine with gemcitabine in metastasis pancreatic cancer. The investigators planed to enroll 33 patients for each arm after randomization.
  The inclusion criteria included:
  1. Patients shall have normal organic function such as liver function, Cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  The investigators will evaluated the quality of life by SF-36 scale as primary outcome. The second outcomes include anxious and depression scores, objective response rate, progress free survival, overall Survival and chemotherapy induced nausea and vomiting.

Eligibility: Inclusion Criteria:
  1. Patients of pancreatic cancer shall have normal organic function such as liver function, cardiac function and renal function.
  2. Before enrolled, anxious and depression states will be evaluated by the Hamilton degree of depression and anxiety scale. Only patients with definite depression and/or anxiety will be considering participating this trial.
  3. Pancreatic cancer patients with ECOG 1～2 scores will be enrolled.
  4. Patients should be expected to live no shorter than 1.5 months
  Exclusion Criteria:
  1. Patients receiving other anti-cancer drugs;
  2. Patients who discontinue anti-cancer drugs less than 4 weeks, for patients who received Postoperative adjuvant chemotherapy less than 6 weeks. Shorter than 4 weeks after operation;
  3. Patient with inadequate Blood system,liver function and renal function.
  4. Brain metastasis is of symptoms
  5. Patient with arrhythmia,myocardial ischemia,serious atrioventricular block,inadequate cardiac function,serious valvular heart disease;
  6. Chronic enteritis or intestinal obstruction
  7. Bone marrow failure
  8. Mental disease difficult to control
  9. Participated other clinic trial within 3 months
  10. Pregnant or lactation patients
  11. The researcher evaluate the patient is not suitable for this trial.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: EUS Guided Celiac Neurolysis

Summary: -  Hypothesis:
  - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma.
  -  Rationale:
  -  Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.


Eligibility: Inclusion Criteria:
  -  1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
  -  2. Cytologic or histologic confirmation of pancreatic carcinoma
  -  3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
  -  4. EUS clinically indicated (for non-study purposes)
  Exclusion Criteria:
  -  1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
  -  2. Abdominal surgery within 1 month
  -  3. Prior celiac plexus or ganglia neurolysis.
  -  4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
  -  5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Slide Interpretation or Standard Surgical Pathology in Assessing Margin Status in Patients With Pancreatic Cancer Undergoing Surgery

Summary: This study is being done to investigate another way of evaluating margin status after pancreatectomy by using cytopathology (slide interpretation) as compared to the traditional method of surgical pathology

Detailed description: PRIMARY OBJECTIVES:
  I. To compare margin status on final pathology with margin status from cytopathologic evaluation.
  OUTLINE:
  Patients undergo cytopathologic sample collection during pancreatic resection during which slides are gently pressed against the cut edge of the pancreas, the surgical bed, and along the superior mesenteric artery, and finally against the tumor itself.

Eligibility: Inclusion Criteria:
  -  patients undergoing pancreatic resection for a presumed, although not necessarily biopsy-proven pancreatic malignancy,
  -  ages 18 years to 80 years old
  Exclusion Criteria:
  -  Pregnant women

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Ultrasound-assisted Treatment of Inoperable Pancreatic Cancer

Summary: The investigators primary aim is to increase chemotherapeutic drug uptake in inoperable tumours
  The specific sub-objectives of the studies are:
  -  To quantify tumour sizes and relate it to the patient survival over time, dependent of treatment method.
  -  To evaluate and compare the toxic effects and safety of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone.
  -  Develop and validate new ultrasound perfusion algorithms based on burst- replenishment for diagnosis and monitoring of therapy.
  -  To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
  -  To assess plasma and tissue concentrations of gemcitabine, its main metabolites and endogenous nucleotides in those patients where surgical resection can be performed on standard clinical indications.

Detailed description: The primary outcome is monitor for toxicity effect for the combination therapy.

Eligibility: Inclusion Criteria:
  -  Patients with inoperable pancreatic cancer (ICD-10 C25.0-3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate
  Exclusion Criteria:
  -  Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
  -  Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
  -  Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
  -  Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
  -  Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
  -  Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
  -  Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
  -  Patient is pregnant or is breast-feeding.
  -  Patient is allergic to or intolerant of gemcitabine
  -  Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
  -  Any reason why, in the opinion of the investigator, the patient should not participate.

Relevance to patient case: not relevant