araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Summary: Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.

Detailed description: Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.
  Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.
  -  Trial with medicinal product

Eligibility: Inclusion criteria: - Age > 18 years
  -  Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
  -  WHO-performance status 0-2
  -  Written informed consent
  -  Discussion in an intrdisciplinary conference
  Exclusion criteria: - Insufficient renal function (calculated creatinin clearance < 60ml(min)
  -  Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)
  -  Uncorrectable coagulopathy
  -  Severe cholestasis (bilirubin >100mmol/l)
  -  Distant metastases in liver, lungs or other organs
  -  Peritoneal carcinomatosis
  -  Unresectable tumor (s. 4.2.)
  -  Contraindication for Whipple procedure
  -  Uncontrolled infection
  -  Neurotphil count > Â°2
  -  Estimated life experience < 6 months
  -  HIV Infection
  -  Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
  -  Female patients in child-bearing age without adequate contraception

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: Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Summary: Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Detailed description: Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.
  Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.
  B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

Eligibility: Inclusion Criteria:
  -  Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.
  Exclusion Criteria:
  -  The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

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: Clinical Outcomes in Hereditary Cancer

Summary: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
  Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Detailed description: Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .
  Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

Eligibility: Inclusion Criteria:
  -  Included in DB0363-03
  -  Jewish religious preference at registration
  -  Archival material available for testing
  -  Adequate post-surgical follow-up
  -  Jewish religious preference at registration
  -  Archival material available for testing
  -  Adequate follow-up to determine time to progression
  Exclusion Criteria:
  -Subjects will not be included in the analyses if a DNA sample cannot be obtained.

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: Capecitabine and Oxaliplatin in Patients With Advanced or Metastatic Pancreatic Adenocarcinoma

Summary: There are limited treatment options available for patients with advanced pancreatic ductal adenocarcinoma (PDAC). The purpose of this study is to determine the effectiveness and safety of the drugs capecitabine and oxaliplatin in patients who have been diagnosed with advanced and metastatic PDAC treated in the first and second lines.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the response rate to capecitabine and oxaliplatin in patients with locally advanced or metastatic pancreatic adenocarcinoma Secondary
  -  To determine safety
  -  To determine overall survival
  -  To determine time to progression

Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  At most one prior chemotherapy regimen for unresectable or metastatic disease. Any adjuvant chemotherapy must have been completed more than 12 months prior to beginning protocol therapy
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  At least one measurable lesion according to RECIST criteria that has not been irradiated
  -  Adequate laboratory parameters as outlined in protocol
  -  Anticoagulation with coumadin is permitted, but PT/INR must be monitored closely, given the drug-drug interaction between coumadin and capecitabine
  -  Negative serum pregnancy test within 14 days prior to registration
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Life expectancy < 3 months
  -  Serious, uncontrolled, concurrent infection(s)
  -  Any prior oxaliplatin or fluoropyrimidine therapy
  -  More than one prior chemotherapy regimen for unresectable or metastatic disease
  -  Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil or platinum compounds
  -  Any active second malignancy
  -  Clinically significant cardiac disease or myocardial infarction within the last 12 months
  -  Evidence of CNS metastases or history of uncontrolled seizures, central nervous system disorders or psychiatric disability
  -  Other serious uncontrolled medical conditions
  -  Major surgery within 4 weeks of the start of study treatment, without complete recovery
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
  -  Known, existing uncontrolled coagulopathy

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: CT Pancreas Perfusion

Summary: 1. Pancreatic CT perfusion with a biofeedback breathing belt worn by the participant, and using novel post-processing techniques, is a reliable method which can be used to differentiate between pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis.
  2. Pancreatic CT perfusion can be used to monitor patients undergoing decompression treatment (endoscopic retrograde cholangiopancreatography with stent placement) for painful chronic pancreatitis, and the change in the pancreatic perfusion parameters correlate with the change in the pain parameters (pain scale and analgesic use).
  3. Pancreatic CT perfusion parameters can be calculated using surrogate scan data sets at specific time points to replace the continuous scanning.


Eligibility: Inclusion Criteria:
  1. a. Suspected pancreatic adenocarcinoma, age 35 to 99 years.
  2. a. Chronic pancreatitis with chronic pain, age 18 to 99 years. Must be a confirmed diagnosis by either CT, endoscopic ultrasound (EUS), or endoscopic retrograde cholangiopancreatography (ERCP).
  2b. To undergo endoscopic or surgical decompression with 0 to 10 days of first study visit CT perfusion scan.
  2c. To answer pain questionnaire before first CT perfusion scan.
  2d. To return within three weeks to three months after decompression treatment for another CT perfusion scan and complete the second pain questionnaire.
  3a. Autoimmune pancreatitis, age 18 to 99 years either with diffuse or focal swelling of the pancreas confirmed by CT, MRI, or EUS or
  3b. Irregular narrowing of the pancreatic duct on ERCP and either elevated serum immunoglobulin G4 (IgG4), or histological confirmation.
  Exclusion Criteria:
  1a. Pancreatic ductal adenocarcinoma tumors with vascular involvement but without vascular occlusion.
  1. b. Pancreatic ductal adenocarcinoma tumors less than 2 cm in size.
  2. a. Chronic pancreatitis with diffuse and extensive pancreatic calcification.
  3. a. Autoimmune pancreatitis with a prior pancreas surgery or steroid treatment for autoimmune pancreatitis .
  Any Cohort:
  4. Pregnant.
  5. Prior iodine contrast reactions.
  6. Iodine allergy.
  7. Decreased kidney function being a serum creatinine greater than 1.5mg/dl.
  8. Any contraindication to having a CT scan with iodine contrast.

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: The Prognostic Impact of Extracapsular Lymph Node Involvement in Ductal Pancreatic Adenocarcinoma

Summary: Extracapsular lymph node involvement (ECLNI) has been identified as a pathological variable associated with worse outcome in esophageal, gastric and colorectal cancer. No studies so far have studied its prognostic impact in ductal pancreatic adenocarcinoma (DPAC). The goal of the investigators is to determine the prognostic value of ECLNI in a prospective consecutive series of 145 patients with DPAC, who underwent resection of their primary tumor between 1998 and 2005.

Detailed description: Presence and extent of extracapsular lymph node involvement (ECLNI) will be scored by reviewing all original pathological slides.
  ECLNI is defined as metastatic adenocarcinoma extending through the nodal capsule into the perinodal fatty tissue.
  Observers: 1 experienced board-certified GI pathologist, blinded for follow-up results.
  Follow-up data are obtained by reviewing patients charts and by a telephone survey of the patient's GP/gastroenterologist in November 2007.
  Statistical analysis:
  -  Common closing date: 1/11/2007
  -  Kaplan-Meier survival analysis (Log-Rank, Wilcoxon)
  -  Cox logistic regression (uni/multivariate)

Eligibility: Inclusion Criteria:
  -  DPAC
  -  Primary resection
  Exclusion Criteria:
  -  Positive section margins
  -  non DPAC, other tumor
  -  Postoperative mortality
  -  Neoadjuvant chemo/radiotherapy

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: Phase I Study of U3P1287/01, Including Patients With Advanced Solid Tumors

Summary: This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.


Eligibility: Key Inclusion Criteria:
  -  Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  -  Men or women at least 18 years of age
  -  Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function
  Key Exclusion Criteria:
  -  Presence of untreated or symptomatic brain metastasis.
  -  Presence of ascites or pleural effusion requiring chronic medical intervention.
  -  Uncontrolled hypertension
  -  Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
  -  Recent major surgical procedure or not yet recovered from major surgery
  -  Recent participation in clinical drug trials.
  -  Participation in other investigational procedures.
  -  Unresolved toxicities from prior anti-cancer therapy
  -  Patient who is pregnant (e.g. positive human choriogonadotropin [HCG] test) or nursing.

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: Permission to Collect Blood Over Time for Research

Summary: To determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. The ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.


Eligibility: Inclusion Criteria:
  -  Male or female, >= 18 years old. There are no ethnic restrictions.
  -  Active cancers of the GI tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed TNM staging by the American Joint Committee on Cancer; stage III disease if diagnosed within 2 months and all stage IV disease
  -  Ability to understand and the willingness to sign a written informed consent document.
  -  Existing staging CT imaging study
  Exclusion Criteria:
  -  Life expectancy < 6 months
  -  History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  -  Known pregnancy or positive urine pregnancy test in pre-menopausal women
  -  On anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors)
  -  No CT imaging studies, or contraindications to undergoing CT imaging
  -  Existing or anticipated need for a tunneled central venous catheter
  -  Clinic visitation to Stanford Cancer center for secondary consultation purposes only
  -  Inability to give informed consent

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: Minimally Invasive Detection of Lymphatic Micrometastases in Pancreatic Cancer

Summary: The major goal of this project is to reduce unnecessary pancreatic resections, namely resection in those patients with non-regional lymph node metastatses that cannot be cured with surgical resection. By combined minimally invasive methods for non-surgical biopsy and highly sensitive molecular assays for cancer cells, we believe we can increase the ability to detect distant lymph node metastases prior to surgical resection, and direct those patients for more appropriate therapy (including possible neo-adjuvant chemotherapy with or without surgery). We hypothesize that the combination of EUS-FNA and polymerase chain reaction (PCR) of a multimarker panel will increase the sensitivity for malignant lymph nodes compared with EUS-FNA cytology in patients with pancreatic ductal adenocarcinoma.


Eligibility: Inclusion Criteria:
  -  Patients with a mass in the pancreas suspicious for adenocarcinoma without biopsy proven distant metastases.
  -  Patients who are scheduled for clinically indicated EUS
  Exclusion Criteria:
  -  Patients who are medically unfit for endoscopic sedation or surgery due to severe comorbid disease such as uncontrolled coronary disease, or oxygen dependant pulmonary disease.
  -  Patients who have any other malignancy other than basal cell carcinoma within the past 5 years.

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: Recurrence and Distant Metastases in Hepatocellular Carcinoma Treated by Transcatheter Arterial Chemoembolization

Summary: This project will include at least 40 patients with hepatocellular carcinoma (HCC) who will receive transcatheter arterial chemoembolization (TACE) as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.

Detailed description: Transcatheter arterial chemoembolization (TACE) is the traditional method for the palliative management of patients with hepatocellular carcinoma (HCC). This method will cause tissue hypoxia in area of embolization. Several proangiogenic factors will be induced by the condition of hypoxia. This may have the possibility to promote the proliferation of the residual cancer cells. However, there is no study to clarify this issue. This project will determine the serial changes of serum proangiogenic factors (vascular endothelial growth factor, angiopoietin 2), antiangiogenic factor (endostatin) and cathepsin L before and after TACE. These data will be compared with the clinical courses of the patients to obtain the most suitable way in the management of these patients.
  This project will include at least 40 patients with HCC who will receive TACE as a sole method for the management. The serum is collected before and at the 3rd and 7th day after TACE. The serum levels of vascular endothelial growth factor, angiopoietin 2, endostatin and cathepsin L are determined. All patients will be evaluated according to the TNM system for the cancer staging before and 3 months after each session of treatment. The vascularity of tumor, the drug and the dose used for embolization, and the area of infarction will be recorded.

Eligibility: Inclusion Criteria:
  -  patients with hepatocellular carcinoma treated by transcatheter arterial chemoembolization
  Exclusion Criteria:
  -  patients with hepatocellular carcinoma unable to be treated by transcatheter arterial chemoembolization

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: Anastomotic Techniques in Pancreaticoduodenectomy

Summary: There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.
  Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior


Eligibility: Inclusion Criteria:
  1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
  2. resectable tumour
  Exclusion Criteria:
  1. chronic pancreatitis/benign tumours-
  2. tumours extending into the body of the pancreas
  3. tumours with metastasis beyond regional lymph nodes
  4. requirement for sub total pancreatectomy
  5. prolonged hypotension - < 80 mm of hg for more than 30 min

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: Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

Detailed description: OBJECTIVES:
  Primary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.
  Secondary
  -  Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.
  OUTLINE: This is a multicenter study.
  Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.
  PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility: All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

Relevance to patient case: not relevant