araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

Summary: The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
  The experimental part of the study is combining these drugs together in FOLFOX-A.

Detailed description: More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed pancreatic ductal adenocarcinoma.
  -  Metastatic or locally advanced disease.
  -  No prior treatment for pancreatic cancer
  -  Radiographically measurable disease.
  -  No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
  -  Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  -  Preexisting neuropathy > grade 1.
  -  No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  -  ECOG performance status 0 or 1.
  -  Age ≥ 18 years of age.
  -  Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
  -  Required Initial Laboratory Values:
  -  Neutrophils ≥ 1,500/μl
  -  Platelet count ≥ 100,000/μl
  -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
  -  Total bilirubin ≤ 1.5 x ULN
  -  AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN
  Exclusion Criteria:
  -Patients with known brain metastases

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: DGT Versus TPS in Patients With Initial PD Cannulation by Chance; Prospective Multi-center Study

Summary: In patients with pancreatic duct cannulation initially by chance, double guide wire technique and trans pancreatic sphincterotomy facilitate biliary cannulation and show the similar success rates. The incidence of post-procedure pancreatitis was similar in the two groups, but post-procedure hyperamylasemia was significantly higher in the DGT group.

Detailed description: This was a prospective, randomized study conducted in three tertiary referral hospital in Korea. Three endoscopists performed the ERCP who had ERCP experience more than ten years From October 2010 to August 2012, ERCPs were performed on patients with pancreatobiliary diseases at Soonchunhyang University Seoul Hospital, Hanyang University Guri Hospital and Kosin University Gospel Hospital. Bile duct cannulation was attempted for various reasons (removal of bile duct stones, biliary stenting, cytology of bile, biopsy of the bile duct, etc.).
  Patients who satisfied the following inclusion criteria were enrolled in this study: (1) initially pancreatic duct cannulation by chance, (2) successful insertion of the guidewire into the pancreatic duct to at least half of the presumed total length of the pancreatic duct,, and (3) age 20 years or older. Exclusion criteria were: (1) refusal the ERCP, (2) previous endoscopic sphincterotomy or endoscopic papillary balloon dilatation, (3) acute pancreatitis at the time of the procedure, (4) pregnancy and (5) anatomical change due to past surgery; total gastrectomy, Billroth II operation, Whipples's operation etc. Patients who satisfied the inclusion criteria were randomly assigned to either the double-guidewire technique (DGT) group or the transpancreatic precut sphincterotomy (TPS) group; A randomization list for group allocation was generated by using computer-based pseudo-random number generators. We compared both techniques , for a maximum of ten extra attempts which are CBD cannulation by each methods. We obtained the written informed consent from all enrolled patients.

Eligibility: Inclusion Criteria:
  -  ERCP patient, over 20 years old, pancreatic duct cannulation patients by chance
  Exclusion Criteria:
  -  refuse the ERCP, post procedure state(EST, subtotal gastrectomy, Whipples' Op except gastroduodenostomy), use another method, under 20 years old.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: 18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Summary: The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. We will assess the uptake of this novel radiopharmaceutical in subjects with breast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring antiangiogenesis treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. Evaluate 18F FPPRGD2 PET/CT or PET/MRI for prediction and early assessment of response to anti-angiogenesis therapy in patients with non-small cell lung cancer (NSCLC), breast cancer, glioblastoma multiforme (GBM) and other cancers.
  OUTLINE:
  Patients undergo 18F FPPRGD2 PET/CT or PET/MRI at baseline, 1 week, and 6 weeks (or standard of care follow-up) and 18F FDG PET/CT at baseline and 6 weeks (or standard of care follow-up) .
  After completion of study imaging, patients are followed up at 12 months.

Eligibility: Inclusion Criteria:
  -  Provides written informed consent
  -  Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment
  -  Able to remain still for duration of each imaging procedure (about one hour)
  Exclusion Criteria:
  -  Pregnant or nursing

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: EUS-guided Intratumoral Gemcitabine in Locally Advanced Unresectable Pancreatic Cancer

Summary: Pancreatic cancer is the 11th most common type of cancer but it is the fourth leading cause of cancer death. The only effective treatment for pancreatic cancer includes surgery. However, only 20% of the patients have surgically treatable disease. Also, the 5-year survival for the surgically treated patients is only 15%.
  About 40% of the patients present with advanced disease with distant metastasis, and the remaining 40% present with locally advanced unresectable cancer with the tumor invaded into surrounding major vessels. For those with locally advanced disease, systemic chemotherapy with or without radiotherapy provides palliation of the symptoms but cannot cure the disorder. Systemic chemotherapy is given through peripheral vessels.
  The investigators hypothesized that direct injection of the chemotherapeutic drug into the tumor may help to boost the effect of systemic chemotherapy and radiotherapy in those with locally advanced pancreatic cancer.

Detailed description: In this study, gemcitabine will be injected directly into the tumor by means of endoscopic ultrasound (EUS) in the eligible patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically verified pancreatic adenocarcinoma who have locally advanced unresectable tumor
  Exclusion Criteria:
  -  Early stage resectable pancreatic cancer with the intact surrounding major vessels on imaging
  -  Pancreatic cancer with distant metastasis
  -  Unwilling to sign informed consent

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Chemoimmunotherapy and Radiation in Pancreatic Cancer

Summary: The goal of this study is to evaluate the safety of combination treatment that includes chemotherapy, radiation therapy, and immunotherapy in patients with pancreatic cancer.

Detailed description: This study is for borderline resectable and advanced pancreatic cancer patients. Patients will receive chemotherapy with gemcitabine and immunotherapy with daily tadalafil during the first 21 days of treatment. On study day 22, patients will receive the first of three planned doses of radiation therapy and continue daily tadalafil. Patients are then evaluated to determine if they are candidates for pancreaticoduodenectomy. Patients who are not candidates will continue daily tadalafil and receive gemcitabine chemotherapy. Patients who have surgery will resume daily tadalafil and gemcitabine chemotherapy following recovery from surgery. Patients will receive up to four cycles of gemcitabine.

Eligibility: Inclusion Criteria:
  -  Pancreatic adenocarcinoma
  -  Locally advanced unresectable disease, or borderline resectable disease
  -  ECOG (Eastern Cooperative Oncology Group)Performance Status 0 or 1
  -  Ability to provide consent and comply with study protocol
  -  Women of child-bearing potential must have a negative pregnancy test and avoid pregnancy during the study
  Exclusion Criteria:
  -  Age < 18
  -  History of other malignancy in previous 2 years except carcinoma in situ of the cervix or bladder, or non-melanoma skin cancer
  -  Previous chemotherapy or radiation therapy for pancreatic cancer or previous radiation to the target field
  -  Clinically active autoimmune disease or active infection
  -  History of heart attack within 90 days or stroke within 6 months, hypertension requiring change in blood pressure medications in the last 4 weeks, hypotension, uncontrolled arrhythmias, heart failure (NYHA >= Class 2 in last 6 months), unstable angina, or angina during sexual activity
  -  Use of nitrates or nitroglycerin
  -  History of hereditary degenerative retinal disorders including retinitis pigmentosa
  -  Chronic systemic corticosteroid use at supra-physiologic doses
  -  Use of recreational drugs called 'poppers' like amyl nitrite and butyl nitrite
  -  Blood test results (neutrophils < 1000 /uL (microliter); hemoglobin < 9 gm /dL; platelet count < 1000 cells / uL; significant coagulopathy; significant liver or renal dysfunction

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of Veliparib (ABT-888) in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Locally Advanced, Unresectable Pancreatic Cancer

Summary: This is a Phase I Study of veliparib (ABT-888) in combination with Gemcitabine and Intensity Modulated Radiation Therapy in Patients with Locally Advanced, Unresectable Pancreatic Cancer.
  Primary Objectives:
  -  Determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer.
  -  Determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer

Detailed description: Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a dose escalation schema. The starting dose of veliparib is 20 mg BID based upon safety/efficacy data available. Dose escalation will continue in 20 mg increments until the maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.

Eligibility: Inclusion Criteria:
  -  Patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.
  -  Age 18 years or older
  Exclusion Criteria:
  -  Patients who have had prior anti-cancer treatment for their disease
  -  Patients who are currently receiving any other investigational agents
  -  Metastatic disease
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Magnetic Resonance Imaging Study of Acute Pancreatitis

Summary: To quantitatively analyze the T2* values of the head, body, and tail of normal pancreas, and observe the value of GRE T2*-weighted MRI in the diagnosis of acute pancreatitis and the relationship between the T2* value and the severity of AP.

Detailed description: 1. We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".
  2. We apply for an account and register our study on the clinicalTrials.
  3. In patients with acute pancreatitis, imaging is recommended to confirm the clinical diagnosis, investigate the etiology, and grade the severity of the disease . MR had the excellent resolution of soft tissue，and it has earned an ever more important role in the diagnosis of AP. With the continuous development of MR scanning techniques, the sequence of a multi-echo gradient recalled echo (GRE) T2*-weighted imaging (T2*WI), which acquires a spin echo signal, T2* relaxation acquires a gradient echo signal, is a relatively new MRI technique. The sequence of a GRE T2*WI requires high uniformity of the magnetic field, plus it can provide the T2* value, which can indirectly reflect changes in tissue biochemical components, thus it can be used for the early diagnosis quantitative diagnosis of some diseases .
  4. This calculation process for T2* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.
  5. AP is a process of inflammation diffusion, in which cell edema will lead to hydrogen proton increase. In the inflammatory exudation process, T2* value will change. So we conduct our research. In this study, we will observe pancreas in the normal pancreas and AP, and discuss the relationship between T2* value and that of AP graded by the MR severity index (MRSI) and Acute Physiology And Chronic Healthy Evaluation II (APACHE II) scores.
  6. However, until now, there is no research on the sequence applied in the patients with AP.

Eligibility: Inclusion Criteria:
  -  acute onset of abdominal pain;
  -  pancreatitis at first onset;
  -  three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and
  -  abdominal MR examination.
  Exclusion Criteria:
  -  inability to cooperate when MR imaging was performed;
  -  a history of chronic pancreatitis;
  -  AP due to pancreatic carcinoma;
  -  hypoproteinemia;
  -  with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;
  -  with iron deposition disorder (e.g. diabetes or blood system diseases).

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

Summary: This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Detailed description: This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Eligibility: Inclusion Criteria:
  1. Patients with the following indications:
  i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
  -  For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
  -  For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
  2. ECOG Performance Status of 0-2
  3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
  4. Willingness and ability to comply with all study procedures
  5. Written informed consent obtained prior to any screening procedures
  6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Analgesia and Pancreatic Cancer Surgery

Summary: Long-term survival for patients with pancreatic carcinoma is low, even following resection, the 5-year survival rate of patients ranges from 10 to 25%1. Most treatment failure is due to local recurrence, distant metastasis or both within one to two years after surgery2-4.
  Surgery has been suggested to accelerate the development of preexisting micro metastases and to promote the establishment of new metastases5. Release of catecholamine and proinflammatory products secondary to surgical stress is believed to promote cancer progression6. Maintenance of proper anesthetic depth is beneficial to attenuate surgical stress. However, general anesthesia including numerous induction agents, volatile anesthetics and opioids, is associated with immunosuppression especially on the cell-mediated immunity which has a crucial role in prevention of micrometastasis5,7. Therefore, regional anesthesia and analgesia which effectively attenuating surgical stress while efficiently reducing general anesthetics consumption, seem to provide promising advantages to prevent perioperative cancer progression. Currently, most studies available in humans are retrospective and observational to evaluate regional anesthesia and prostate, colorectal, breast and cervical cancer-related outcomes8-12. Only one randomized study investigating major abdominal cancer surgery is available13. However, it is not specific to an individual cancer type and perioperative cell-mediated immunity is not evaluated.
  In this study, we aimed to identify whether epidural block beneficial to early surgical and late cancer-related outcomes in patients receiving pancreatic cancer surgery. Perioperative cell-mediated immunity functions including natural killer cells, helper and cytotoxic T-lymphocytes were also investigated.


Eligibility: Inclusion Criteria:
  -  Pancreatic cancer expected to receive curative Whipple operation
  Exclusion Criteria:
  -  palliative operation
  -  preoperative chemotherapy or radiotherapy
  -  patients with metastasis
  -  contraindications for epidural catheter placement
  -  prior spine surgery

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

Summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.
  Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.
  In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility: Inclusion Criteria:
  -  Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
  -  Available histopathological diagnosis of the malignancy.
  Exclusion Criteria:
  -  Patients with inoperable tumors.
  -  Patients with second primary tumor.
  -  Patients with pathological blocks not enough for future slicing.

Relevance to patient case: not relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Summary: The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.


Eligibility: Inclusion Criteria:
  -  subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
  -  subject must have adequate renal function
  -  ECOG performance status of 0-2
  -  women of child-bearing age and men must agree to use contraception prior to and during the study
  Exclusion Criteria:
  -  subjects receiving any other investigational agents
  -  significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
  -  pregnant or breastfeeding women

Relevance to patient case: not relevant