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

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

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: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: Everolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma

Summary: RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
  PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory multiple myeloma.

Detailed description: OBJECTIVES:
  Primary
  -  To assess the response rate in patients with relapsed or refractory multiple myeloma treated with everolimus.
  Secondary
  -  To evaluate the toxicity of everolimus in patients with multiple myeloma.
  -  To study the tumor cells and blood from patients entering this trial for laboratory correlates.
  OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  Patients undergo bone marrow aspirate, biopsy, and blood sample collections periodically. Samples are assessed for the following: cyclin D1, phospho-AKT, phospho-p70 S6 kinase, and phospho-S6 by western blot; checkpoint regulators PTEN, p53, pRB, and p27 by immunoblotting; p53, Rb, p16, PTEN, p27, and cyclin D1 by DNA analysis; caspases 3 and 9 by immunoblotting and Annexin/PI by flow cytometry; unknown molecular markers by protein profiling; and microvessel density.
  After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of multiple myeloma, meeting 1 of the following criteria:
  -  Monoclonal protein in the serum of ≥ 1 g/dL
  -  Monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours
  -  Measurable light chains by free light chain assay of ≥ 10 mg/dL
  -  Measurable plasmacytoma
  -  Must have received prior therapy and have relapsed or refractory disease
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2
  -  Life expectancy ≥ 12 weeks
  -  ANC ≥ 1,000/mm³
  -  Platelet count ≥ 75,000/mm³
  -  Hemoglobin ≥ 8.0 g/dL
  -  Total bilirubin ≤ 2.0 mg/dL (if total bilirubin is elevated, direct bilirubin must be normal)
  -  AST ≤ 3 times upper limit of normal (ULN)
  -  Creatinine ≤ 1.5 times ULN
  -  Calcium < 11 mg/dL
  -  No uncontrolled infection
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  No HIV positivity
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  At least 3 weeks since prior cytotoxic chemotherapy
  -  At least 2 weeks since prior biologic therapy or radiotherapy
  -  At least 2 weeks since prior corticosteroids
  -  Concurrent chronic corticosteroids allowed for treatment of disorders other than myeloma
  -  No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational

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

Clinical trial: Gemcitabine With Antiangiogenic Peptide Vaccine Therapy in Patients With Pancreatic Cancer

Summary: The purpose of this study is to evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose.

Detailed description: Vascular endothelial growth factor receptor 2(VEGFR2) is essential target for tumor angiogenesis, and VEGFR2-169 induces specific Cytotoxic T lymphocytes (CTL) against VEGFR2 expressed targets. VEGFR2-169 shows strong anti-tumor effects restricted to HLA-A*2402 in vitro, and this peptide induces CTL from cancer patients. 60% in Japanese population have HLA-A*2402. VEGFR2-169 is suitable for clinical trial, and gemcitabine has been approved against pancreatic cancer. Gemcitabine is reported to improve immune-response, therefore synergistic effect between vaccine therapy and chemotherapy will be expected. In this clinical trial, we evaluate the safety, tolerability and immune response of different doses of VEGFR2-169 emulsified with Montanide ISA 51 in combination with gemcitabine and to determine the recommended phase II dose of peptide.

Eligibility: Inclusion Criteria:
  DISEASE CHARACTERISTICS
  1. locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  2. measurable disease by CT scan
  PATIENT CHARACTERISTICS
  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. Laboratory values as follows
  -  2000/mm3 < WBC < 15000/mm3
  -  Platelet count > 75000/mm3
  -  Bilirubin < 3.0 mg/dl
  -  Aspartate transaminase < 150 IU/L
  -  Alanine transaminase < 150 IU/L
  -  Creatinine < 3.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent
  Exclusion Criteria:
  1. Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
  2. Breastfeeding
  3. Active or uncontrolled infection
  4. Concurrent treatment with steroids or immunosuppressing agent
  5. Prior chemotherapy of gemcitabine
  6. Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
  7. Serious or nonhealing wound, ulcer, or bone fracture
  8. Active or uncontrolled other malignancy
  9. Ileus
  10. Interstitial pneumonia
  11. Decision of unsuitableness by principal investigator or physician-in-charge

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

Clinical trial: Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer

Summary: The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Detailed description: Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Eligibility: Inclusion Criteria:
  DISEASE CHARACTERISTICS
  1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer 2. Measurable disease by CT scan PATIENTS CHARACTERISTICS
  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. Laboratory values as follows 2,000/mm3 < WBC < 15000/mm3 Platelet count ≥ 750,000/mm³ Total Bilirubin ≤ 1.5 x Aspartate transaminase < 150 IU/L Alanine transaminase < 150 IU/L Creatinine ≤ 3.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent
  Exclusion Criteria:
  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breast-feeder
  3. Active or uncontrolled infection
  4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  5. Serious or aggravated wound
  6. Active or uncontrolled other malignancy
  7. Steroids or immunosuppressing agent dependant status
  8. Interstitial pneumonia
  9. Ileus
  10. Decision of unsuitableness by principal investigator or physician-in-charge

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

Clinical trial: Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

Summary: The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Detailed description: Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Eligibility: Inclusion Criteria:
  DISEASE CHARACTERISTICS
  1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
  2. Measurable disease by CT scan
  PATIENTS CHARACTERISTICS
  1. ECOG performance status 0-2
  2. Life expectancy > 3 months
  3. Laboratory values as follows:
  -  2,000/mm3 < WBC < 15000/mm3
  -  Platelet count ≥ 750,000/mm³
  -  Total Bilirubin ≤ 1.5 x
  -  Aspartate transaminase < 150 IU/L
  -  Alanine transaminase < 150 IU/L
  -  Creatinine ≤ 3.0 mg/dl
  4. HLA-A*2402
  5. Able and willing to give valid written informed consent
  Exclusion Criteria:
  1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
  2. Breast-feeder
  3. Active or uncontrolled infection
  4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
  5. Serious or uncured wound
  6. Active or uncontrolled other malignancy
  7. Steroids or immunosuppressing agent dependent status
  8. Interstitial pneumonia
  9. Ileus
  10. Decision of unsuitableness by principal investigator or physician-in-charge

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

Clinical trial: Tight Glycemic Control by Artificial Pancreas

Summary: This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.

Detailed description: This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.

Eligibility: Inclusion Criteria:
  -  This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
  Exclusion Criteria:
  -  weight loss greater than 10% during the previous 6 months
  -  signs of distant metastasis
  -  respiratory, renal,or heart disease
  -  Patients provided written informed consent prior to enrollment

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

Clinical trial: Effect of an Artificial Pancreas in Patients Undergoing Pancreatic Resection

Summary: This study evaluated that strict control of perioperative blood glucose following pancreatic resection by using an artificial pancreas would improve postoperative surgical site infection.

Detailed description: This study recruited 50 patients undergoing elective pancreatic resection for pancreatic diseases. Perioperative blood glucose concentration was continuously monitored using an artificial pancreas system. We prospectively divided into two groups: one for whom glucose levels were controlled using a manual injection of insulin according to the commonly used sliding scale and another that received programmed infusion of insulin determined by the control algorithm of the artificial pancreas.

Eligibility: Inclusion Criteria:
  -  patients undergoing elective pancreatic resection for pancreatic diseases.
  Exclusion Criteria:
  -  weight loss greater than 10% during the previous 6 months
  -  sign of distant metastasis
  -  respiratory, renal, or heart disease

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 Single-Patient Study Using AGS 006

Summary: Argos Therapeutics, Inc., (Argos) proposes to study AGS-006 in a subject with newly diagnosed resectable pancreatic cancer. The AGS 006 immunotherapeutic may potentially offer a desired additional option to conventional treatments for pancreatic carcinoma.

Detailed description: Single-patient, open-label clinical study:
  -  Events during Pre-Treatment Period:
  1. Resection of pancreatic cancer,
  2. RNA acquisition from tumor specimen,
  3. RNA amplification,
  4. Infectious disease testing,
  5. Autoimmune disease testing,
  6. Two blood draws for immune response monitoring,
  7. Production leukapheresis, and
  8. Dendritic cell electroporation with RNA and immunotherapeutic production;
  -  Events during Induction Period:
  1. Administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses,
  2. Two Induction Period blood draws (Week 6 and Week 12) for immune response monitoring, and
  3. One leukapheresis (Week 14) for immune response monitoring;
  -  Events during Booster Period:
  1. Dose every 3 months until progression or 2 years after first AGS treatment,
  2. Potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and
  3. One blood draw 2 weeks following dosing at Week 36 (1st booster dose) (approximately Week 38); and,
  -  Events during study Close-Out:
  1. Close-Out upon progression or 28 days following immune response monitoring 2 years after first dose

Eligibility: Inclusion Criteria:
  -  A male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply:
  1. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
  2. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
  3. Voluntary informed consent given to participate in the study.
  Exclusion Criteria:
  1. Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
  2. Active autoimmune disease including, but not limited to:
  3. Active, acute, or chronic clinically significant infections including human immunodeficiency virus (HIV) and viral hepatitis.
  4. Known hypersensitivity to dimethyl sulfoxide (DMSO).
  5. Body weight less than 30 kg.

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

Clinical trial: Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms

Summary: Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography [PET] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography [FDG-PET] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group [ECOG] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and PYK2 kinase activities.


Eligibility: Inclusion Criteria:
  -  Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic malignancies who have tumor appropriate for serial biopsy.
  -  Adequate organ function, including bilirubin less than 1.5 x ULN, and [Eastern Cooperative Oncology Group] ECOG performance status of 0-2.
  Exclusion Criteria:
  -  Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant cardiac or pulmonary disorders.

Relevance to patient case: possibly relevant
Patient case: 48-year-old male with Pancreatic cancer. Genetic variant: CDK6 Amplification. Other conditions: None.

Clinical trial: DNA Microarray Study of Pancreas Cancer

Summary: Pancreas cancer and precancerous cysts can be difficult to diagnose. Sometimes biopsies do not show cancer when cancer is actually present. We hypothesize that genetic differences exist in tissue that is malignant compared to nonmalignant. When patients present with a pancreas mass or cyst, we biopsy it by fine-needle aspiration during upper endoscopy with ultrasound guidance. We would like to use tissue obtained via endoscopic ultrasound guided fine needle aspiration to perform DNA microarray analysis, and compare the differences in gene expression level in the benign tissue compared to cancerous tissue in order to improve our diagnostic capabilities. DNA microarray measures gene expression level rather than germline mutations. The true diagnosis will be based on cytology, surgical pathology, or clinical followup. The performance of the microarray test as a diagnostic test will be compared to the performance of cytology.


Eligibility: Inclusion Criteria:
  -  Adults aged 18 or older who are able to give informed consent who present for an endoscopic ultrasound to evaluate a pancreas mass or cyst or for suspicion of cancer.
  Exclusion Criteria:
  -  Unable to give informed consent, pregnant or nursing, contraindication to endoscopic ultrasound, no mass or cyst found on ultrasound

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

Clinical trial: Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Summary: Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
  Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
  HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

Detailed description: HLA-A*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.
  These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Eligibility: Inclusion Criteria:
  -  Heterozygote or homozygote of HLA-A*2402 allele
  -  Inoperable or recurrent pancreatic cancer with or without any prior therapy
  -  Difficult to continue the prior therapy due to treatment-related toxicities
  -  ECOG performance status 0-2
  -  Evaluable primary or metastatic lesion with RECIST criteria
  -  Clearance period from prior therapy more than 4 weeks
  -  Life expectancy more than 3 months
  -  Laboratory values as follows 2,000/μL<WBC<15,000/μL Platelet count>100,000/μL AST<150IU/L ALT<150IU/L Total bilirubin<3.0mg/dl Serum creatinine<3.0mg/dl
  Exclusion Criteria:
  -  Pregnancy (refusal or inability to use effective contraceptives)
  -  Breastfeeding
  -  Active or uncontrolled infection
  -  Systemic use of corticosteroids or immunosuppressants
  -  Uncontrollable brain metastasis and/or meningeal infiltration
  -  Unhealed external wound
  -  Possibilities of complicated paralytic ileus or interstitial pneumonitis
  -  Decision of not eligible determined by principal investigator or attending doctor

Relevance to patient case: not relevant