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

Clinical trial: Fecal Microbiota Transplantation (FMT) for Severe Acute Pancreatitis(SAP)

Summary: Severe acute pancreatitis is an acute and rapid progress of the digestive system disease.Most patients with severe pancreatitis associated with intestinal mucosal barrier dysfunction.Intestinal microflora,an important part of the intestinal mucosal barrier, play an important role in the development process in the course of severe acute pancreatitis. At this stage of the study that infection of pancreas and other organs is the leading cause of death in patients with severe acute pancreatitis，and the main pathogens from intestinal micro-organisms， but the intestinal flora changes did not be mentioned. Fecal Microbiota Transplantation that has been used for treatment of inflammatory bowel disease and Clostridium difficile infection may be a new technology for regulation of intestinal mucosal dysfunction and intestinal flora unbalance.

Detailed description: Patients with acute pancreatitis will be assessed depending on APACHE II and CT score and all of them also will be separated into two parts depending on acceptation or refusal of FMT. Blood specimens from patients will be collected to analysis inflammatory factors，and fecal microbiota samples will be detection.

Eligibility: Inclusion Criteria:
  1. The diagnosis of acute pancreatitis: elevated serum amylase and/or lipase levels (more than 3-fold the upper reference limit) and evidence of pancreatitis on computed tomography (CT) of the abdomen;
  2. No chronic diseases of the digestive system ;
  3. No chronic diseases of the urinary system;
  4. No chronic metabolic disease;
  5. No chronic disease of immune system
  6. No chronic disease of mental disease
  7. no acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;
  8. No use of addictive drugs and immune inhibitors
  Exclusion Criteria:
  1. not to match the standard of AP
  2. with chronic diseases of the digestive system;
  3. with chronic diseases of the urinary system;
  4. with chronic metabolic disease;
  5. with chronic disease of immune system
  6. with chronic disease of mental disease
  7. with acute intestinal disease; taking antibiotics anti-inflammatory drugs and history of probiotics for one month;pregnancy and lactation women
  8. with use of addictive drugs and immune inhibitors
  9. exceed the age limits

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

Clinical trial: Risk Factors for the Development of Diabetes Mellitus After Distal Pancreatectomy

Summary: Glucose homeostasis changes after distal pancreatectomy are not well understood. This study aim to identify the incidence of and risk factors for, a change in glucose homeostasis in patients who underwent distal pancreatic resection.

Detailed description: The development of sophisticated surgical procedures, improved postoperative care, and the capacity for early diagnosis of disease, have prolonged life expectancy after pancreatic resection. For these patients, the endocrine function of the pancreas is a critical factor that influences quality of life. In this study, the investigators recruit patients who underwent distal pancreatectomy in Peking Union Medical College Hospital within the last 10 years. Demographic characteristics, operative parameters and short-term postoperative outcomes were collected in a prospective database maintained by the Pancreatic Surgical Centre, Peking Union Medical College Hospital. These patients are followed up regularly by outpatient visiting or telephone for long-term outcomes. The primary outcome of this study is new-onset diabetes mellitus; second outcomes include impaired fasting glucose, impaired glucose tolerance, exocrine insufficiency and disease recurrence. This study aim to determine the cumulative rates of endocrine insufficiency, and identify risk factors for DM development in a large cohort of patients undergoing distal pancreatectomy.

Eligibility: Inclusion Criteria:
  -  Patients undergoing distal pancreatectomy
  Exclusion Criteria:
  -  Patients undergoing pancreaticoduodenectomy, middle pancreatectomy and enucleation
  -  Patients with preoperative DM
  -  Patients with functioning insulinoma and multiple endocrine neoplasia type 1

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

Clinical trial: Predicting Effective Therapy in Pancreatic Cancer

Summary: The purpose of this phase II study is to develop a test to predict response of pancreatic cancer to different chemotherapy regimens.


Eligibility: Inclusion Criteria:
  -  Histological or cytological diagnosis of pancreatic adenocarcinoma, confirmed at MSKCC, AJCC stage IV disease at time of enrollment.
  -  Patient planning to receive treatment with FOLFIRINOX or gem/nab-P chemotherapy, with or without investigational agents.
  -  Prior surgery, chemotherapy and/or radiation therapy for AJCC Stage I-III pancreatic adenocarcinoma is permitted.
  -  ECOG performance status 0-2.
  -  A minimum age of 18 years old.
  Exclusion Criteria:
  -  Prior chemotherapy for AJCC stage IV pancreatic adenocarcinoma
  -  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: Relation Between Cachexia, Diabetes and periNeural Invasion in PANcreatic Cancer- Biomarkers Substudy

Summary: The purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.

Detailed description: In this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes.
  Patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (EUS) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn.
  Thus the investigators propose to identify the protein expression levels of Activin and Midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.
  Furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma.
  Follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.

Eligibility: Inclusion Criteria:
  1. Age over 18 years old
  2. EUS or surgery biopsy confirming the diagnosis of adenocarcinoma
  3. Informed consent
  Exclusion Criteria:
  1. obvious malabsorption
  2. artificial nutrition
  3. hyperthyroidism
  4. major depression
  5. other causes of malnutrition
  6. refusing to enter the study

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-RFA for Inoperable Pancreatic Ductal Adenocarcinoma.

Summary: This study will assess if endoscopic ultrasound radiofrequency application in patients with inoperable pancreatic cancer and chemotherapy confers survival benefit when compared to patients receiving best medical care and chemotherapy .

Detailed description: Prospective randomised clinical study in patients with adenocarcinoma of the pancreas.
  Patients will be randomised 1:1. Patients in the treatment group will receive standard chemotherapy plus 3 radiofrequency ablation procedures, each one month apart.
  Patients in the control group will receive standard chemotherapy and best medical care.

Eligibility: Inclusion Criteria:
  -  Patients above 18 years of age
  -  A cytological/ histological diagnosis of inoperable PDAC based on multidisciplinary review of cross-sectional imaging and cytology/ histology results.
  -  Patients who have been deemed unfit for surgical resection of the PDAC; subjects who are fit for surgical resection, but have declined surgery will also be considered for the study
  -  PDAC patients presenting with jaundice to be considered after a successful biliary drainage (bilirubin <50umol/L)
  -  Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2)
  -  Patients who have commenced chemotherapy are not excluded from the study
  -  Patients capable of giving informed consent
  -  Negative blood pregnancy test for women of childbearing potential
  -  Willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures.
  Exclusion Criteria:
  -  ECOG performance status 3 or 4
  -  Life expectancy less than 3 months
  -  Prior investigational drugs within the last 30 days
  -  Grade > 1 treatment-related toxicities (excluding alopaecia) at the time of screening
  -  Patients with clinically significant cancer ascites
  -  Known infection with human immunodeficiency virus (HIV)
  -  Patient with central nervous system (CNS) metastasis
  -  Major surgery within the last 30 days
  -  Patients with sepsis, obstructive jaundice or encephalopathy
  -  Evidence of spontaneous bacterial peritonitis or renal failure
  -  Pregnant or lactating women
  -  Any other condition (e.g., known or suspected poor compliance, etc.) that, in the judgment of the investigator, may affect the participant's ability to follow the protocol specific procedure

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

Clinical trial: The Role of ctDNA, PVT1 and ROS in Diagnosis and Treatment of Gastrointestinal and Hepatobiliary Pancreatic Cancer

Summary: This study aims to evaluate the role of ct-DNA, PVT1 and reactive oxygen species (ROS) as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.

Detailed description: Epidemiological surveys showed a significant increasing trend of gastrointestinal and hepatobiliary pancreatic cancer in recent years. How can make an early diagnosis of gastrointestinal and liver cancer as well as prognostic evaluation and efficacy monitoring, has become the hotspot. "liquid biopsy", which is meant to detect cancers by sequencing the DNA in a few drops of a person's blood. It may detect cancers early, even before symptoms arise, when there is just a few cells in the blood circulation.
  ct-DNA in cancer patients often bears similar genetic and epigenetic features to the related tumor DNA. There is evidence that some of the ct-DNA originates from tumoral tissue. Besides, ct-DNA can easily be isolated from the circulation and other body fluids of patients, makes it a promising candidate as a non-invasive biomarker of cancer.
  It is known that levels of cellular ROS correlate with the aggressiveness of tumour cells and prognosis of patients. Cancer cells with increased endogenous ROS stress are more sensitive to anticancer agents and high levels of ROS generated by chemotherapeutic agents can induce cell death. Hence, ROS levels before and after chemotherapy in cancer cells can be an early indicator of treatment efficacy, which has the potential to shed new light on the choice of cancer therapy.
  This study aims to evaluate the role of ct-DNA and ROS as biomarkers in the diagnosis, treatment and recurrence monitoring of gastrointestinal and hepatobiliary pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Patients with suspected of gastrointestinal and hepatobiliary pancreatic cancer
  -  Age from 18 - 80 years
  -  No serious organic and mental illness;
  Exclusion Criteria:
  -  Pregnancy
  -  No pathologic result
  -  Suffering other malignancies at the same time.

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

Clinical trial: Trial of NanoPac in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Summary: Open-label, dose-escalating, Phase IIa trial of NanoPac to treat subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas via direct intratumoral injection.

Detailed description: In this open-label, dose-escalating, Phase IIa trial, subjects with locally advanced pancreatic adenocarcinoma located in the tail or body of the pancreas will receive intratumoral (ITU) NanoPac (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
  Subjects will be enrolled in sequential cohorts of NanoPac at escalating doses, at a volume based on up to 20% of calculated tumor volume (with a maximum injection volume of 5 mL per subject). Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following DSMB review of the cohort data, the next cohort may begin enrolling, an additional three subjects at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted.
  The dose determined to be most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile as determined by the Data Safety Monitoring Board (DSMB), will enroll additional subjects to provide a cohort of up to 12 subjects at that dose level.
  Plasma samples will be taken at various time points on the day of NanoPac injection as well as once at each of the study visits, to characterize the pharmacokinetics (PK) of intratumoral NanoPac.
  Subjects will be followed for three months after NanoPac injection for safety, overall survival (OS), progression-free survival (PFS), CA-19-9 levels, carcinoembryonic antigen (CEA) levels, reduction in pain, and tumor response to therapy (as shown by imaging). A follow-up visit may be conducted at six months, as applicable.

Eligibility: Inclusion Criteria:
  -  Signed informed consent;
  -  Age 18 to 75 years;
  -  Histologically/cytologically confirmed locally advanced pancreatic adenocarcinoma; located in the tail or body of the pancreas with a diameter of at least 2 cm but no more than 4cm;
  -  Performance Status (ECOG) 0-1 at study entry; Life expectancy of at least 3 months;
  -  Adequate marrow, liver, and renal function; Platelet count ≥ 75 x 109/L and ANC ≥ 1.5 x 109/L;
  -  Effective contraception if the risk of conception exists.
  Exclusion Criteria:
  -  Prior radiation therapy for pancreatic cancer;
  -  Thrombotic or embolic events;
  -  Acute or subacute intestinal occlusion; History of inflammatory bowel disease;
  -  Known hypersensitivity to study drugs; Known drug or alcohol abuse;
  -  Pregnant or breastfeeding women;
  -  Previous or concurrent history of non-pancreatic malignancy except for metastatic pancreatic disease or non-melanoma skin cancer.

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

Clinical trial: Immunotherapy and Irreversible Electroporation in the Treatment of Advanced Pancreatic Adenocarcinoma

Summary: Compare the efficacy and tolerability of irreversible electroporation in combination with Nivolumab in patients with locally advanced pancreatic cancer.

Detailed description: Immunotherapy and irreversible electroporation in the treatment of advanced pancreatic adenocarcinoma. This is a II study in which all patients undergoing irreversible electroporation of locally advanced pancreatic adenocarcinoma will be treated with nivolumab post-operatively.

Eligibility: Inclusion Criteria:
  -  ≥ 18 years if age
  -  Diagnosed with stage III pancreatic cancer
  -  Tumor is measurable
  -  Glomerular Filtration Rate > 60 m/L/min/1.73 m(2)
  -  Willing and able to comply with the protocol requirements
  -  Able to comprehend and have signed the informed consent to participate
  Exclusion Criteria:
  -  Participating in another clinical trial for the treatment of cancer at time of screening
  -  Are pregnant or currently breast feeding
  -  Have a cardiac pacemaker or Implantable Cardioverter Defibrillator implanted that cannot be deactivated during the procedure
  -  Have non-removable implants with metal parts within 1 cm of the target lesion
  -  Had a myocardial infarction within 3 months prior to enrollment

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

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: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

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