araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer

Summary: To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.


Eligibility: Inclusion Criteria:
  -  Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy.
  -  Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus.
  -  No or minimal smoking history (</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report)
  -  Age 18 years or older
  -  Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf.
  -  Enrollment on any other study, regardless of therapy is allowed.
  -  Enrollment on any other tumor or tissue banking study is allowed.
  -  Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery.
  Exclusion Criteria:
  -  Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease.
  -  Previous surgery for head and neck cancer unrelated to current disease.
  -  Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed)
  -  Patients who have started induction chemotherapy prior to consideration for study eligibility.
  -  Another active cancer except nonmelanomatous skin cancer.
  -  History of cervical penile or anal cancer.
  -  Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania.
  -  History of smoking in the past last 12 months 10 years
  -  History of 10 pack-years of cigarette smoking based on documented history and/or subject report
  -  Presence of sidespread leukoplakia or erythroplakia.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Testing Spectrosense EVA System for Detection of Pancreatic Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

Summary: Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Pancreatic Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven Pancreatic cancer.


Eligibility: Pancreatic cancer Group
  Inclusion Criteria:
  -  Age from 18 years old
  -  Pancreatic cancer positive biopsy
  -  Before any treatment
  -  Signed Informed Patient Consent
  Exclusion Criteria:
  -  Age under 18 years old
  -  Neoadjovant treatment
  -  Post surgery for Pancreatic cancer
  -  A history of any other cancer type, except skin cancer that is not melanoma
  Healthy Group
  Inclusion Criteria:
  -  Healthy patients
  -  No history of Pancreatic cancer
  -  Signed Informed Patient Consent
  Exclusion Criteria:
  -  History of Pancreatic cancer
  -  Pancreatic cancer background in the family
  -  A history of any other cancer type, except skin cancer that is not melanoma

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: The Cancer of the Pancreas Screening-5 CAPS5)Study

Summary: Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.

Detailed description: The Sub Investigator at each site will be responsible for internal monitoring at their site. The site sub Investigator and study team will report any serious adverse events to Principal Investigator and annually report adverse events.

Eligibility: Inclusion Criteria:
  -  Hereditary Pancreatitis or
  -  Peutz-Jeghers Syndrome or
  -  Strong family history of pancreas cancer on one side of the family tree or
  -  Confirmed germline mutation carrier (BRCA2, FAMMM, PALB2, BRCA1, HNPCC, PRSS1/2, or CTRC
  -  Endoscopic evaluation of pancreas scheduled
  Exclusion Criteria:
  -  Medical comorbidities or coagulopathy that contraindicate endoscopy
  -  Prior surgery that prevent optimal endoscopic ultrasound such as partial or complete gastrectomy with Bilroth or Roux-en-Y anastomosis
  -  Stricture or obstruction in the upper GI tract that does not allow passage of the echoendoscope
  -  Poor performance status
  -  Inability to provide informed consent
  -  Pregnancy.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Examination of the Pancreas in New-onset Diabetes

Summary: The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

Detailed description: Compared to the general population, subjects >50 years of age with new-onset diabetes (DM) are 8-times more likely to have pancreatic cancer (PaC). The likelihood of PaC in new-onset DM is further increased in those who have weight loss or elevated CA19-9. In this study patients with newly diagnosed diabetes will be prospectively identified. Those with weight loss and/or elevated pancreatic cancer marker (CA 19-9) will undergo pancreatic imaging. All subjects will be followed up to 24 months. If successful in identifying surgically removable PaC, this study will fundamentally change our practice and will be a major breakthrough in PaC treatment and research.

Eligibility: Patient Characteristics:
  --Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values
  -  No acute illness or steroid therapy
  -  No prior pancreas surgery

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

Summary: Test the safety, immune response and efficacy of GVAX pancreas vaccine (with cyclophosphamide) and CRS-207 compared to chemotherapy or CRS-207 alone in adults with previously treated metastatic pancreatic adenocarcinoma


Eligibility: Inclusion Criteria:
  -  Have histologically proven malignant adenocarcinoma of the pancreas; measurable disease is not required, mixed histology is not allowed; subjects must have metastatic disease
  -  2nd line, 3rd line or greater
  -  At least 18 years of age
  -  ECOG of 0 or 1
  -  Anticipated life expectancy >12 weeks
  -  For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects [male and female], regardless of other methods.)
  -  Have adequate organ function as defined by specified laboratory values
  Exclusion Criteria:
  -  Allergy to both penicillin & sulfa or suspected hypersensitivity to GM-CSF, dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options
  -  Known history or evidence of brain metastases, immunodeficiency disease or immunocompromised state or or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
  -  Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
  -  Have prosthetic heart valves, major implant or device placed in the last 12 months or history of infection with implant/device that cannot be easily removed
  -  Rapidly progressing disease
  -  Clinically significant and/or malignant pleural effusion
  -  Received prior GVAX pancreas vaccine or CRS-207
  -  Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug, or planned surgery requiring general anesthesia
  -  Infection with HIV or hepatitis B or C at screening
  -  Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
  -  Be pregnant or breastfeeding
  -  Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
  -  Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Genetic and Biochemical Characteristics of Human Adipose Tissue

Summary: Research the genetic and biomechanical markers of human adipose tissue on patients with morbid obesity. Additional tissue/fluid collection is also gathered during the time of surgery.


Eligibility: Inclusion Criteria:
  -  Meet NIH Criteria for Bariatric Surgery
  -  Between the Age of 18-65
  -  Dyslipidemia controlled with medication
  Exclusion Criteria:
  -  Uncontrolled Metabolic syndrome (uncontrolled diabetes, htn, dyslipidemia), one or all conditions.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

Summary: This phase Ⅱ study was designed to evaluate the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Detailed description: Although FOLFIRINOX regimen was recently presented to be effective for metastatic pancreatic cancer in selected patients who have good physical condition, there is still insufficient evidence on this regimen in treating patients with metastatic pancreatic cancer in China. Since for many tumors, different races may show different responses to the same regimen, we design this open, multicenter phase Ⅱ study to evaluate the the efficacy and safety of mFOLFIRINOX as first-line treatment for metastatic pancreatic cancer in China.

Eligibility: Inclusion Criteria:
  -  Patients have provided a signed Informed Consent Form
  -  ECOG performance status of 0-1
  -  BMI ≥ 18.5
  -  Age: 18-65 years old
  -  Histologically confirmed diagnosis of metastatic pancreatic cancer
  -  No prior palliative chemotherapy
  -  Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
  -  Life expectancy ≥ 3 months
  -  Patient has adequate bone marrow and organ function
  -  Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L
  -  Platelets ≥ 90 x 109/L
  -  Hemoglobin ≥ 90 g/L
  -  Patient has adequate liver function
  -  AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
  -  Serum bilirubin ≤ 1.2 x ULN
  -  Creatinine ≤ 1.25 times ULN
  -  Good compliance
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Brain metastasis or only with bone metastasis.
  -  Patients with severe gastrointestinal hemorrhage which need frequent blood transfusions.
  -  Refuse to take appropriate contraceptive measures (including male patients).
  -  Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.
  -  Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases.
  -  Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ).
  -  Psychiatric illness that would prevent the patient from giving informed consent.
  -  Patient is concurrently using other antineoplastic agent
  -  Patient has used investigational antineoplastic agent within 4 weeks prior to entry.
  -  Known HIV-positivity.
  -  No history of chronic diarrhea, nausea or vomit.
  -  No ≥ grade 2 sensory peripheral neuropathy.
  -  A history of transmural myocardial infarction (within 6 months prior to entry), congestive heart failure, and unstable angina.
  -  Infectious disease or inflammation with body temperature ≥ 38 ℃.

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

Summary: Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.
  Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Detailed description: Study population: Locally advanced unresectable pancreatic cancer patients
  Elegibility criteria:
  -  Written informed consent
  -  Age >18 < 75 years
  -  Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  -  At least one lesion measurable with CT or MRI scan
  -  Performance Status (ECOG) 0-1 at study entry
  -  Life expectancy of at least 3 months
  -  Adequate marrow, liver and renal function
  -  Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported

Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Age >18 < 75 years
  -  Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
  -  At least one lesion measurable with CT or MRI scan
  -  Performance Status (ECOG) 0-1 at study entry
  -  Life expectancy of at least 3 months
  -  Adequate marrow, liver and renal function
  -  Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)
  Exclusion Criteria:
  -  Previous chemotherapy or radiotherapy for pancreatic cancer
  -  Severe cardiovascular disease
  -  Thrombotic or embolic events
  -  Acute or subacute intestinal occlusion or history of inflammatory bowel disease
  -  Known hypersensitivity to study drug
  -  Known drugs or alcohol abuse
  -  Pregnant or breastfeeding women
  -  Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
  -  Unable to sign informed consent

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: DCE MRI in Diagnosing Patients With Pancreatic Cancer

Summary: This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field and radio frequency pulses. These pictures may help identify underlying malignancy in patients at high risk or active malignancy in patients who have undergone chemotherapy for pancreatic cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
  II. Assess the ability of DCE MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
  III. Assess the ability to DCE MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
  SECONDARY OBJECTIVES:
  I. In each of the three groups listed above clinical factors associated with the presence of pancreatic cancer will be analyzed; in addition, disease free survival and overall survival will be analyzed in each group.
  OUTLINE: Patients are assigned to 1 of 3 groups.
  ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI for up to 3 scans.
  ARM II (Intraductal Papillary Mucinous Neoplasms (IPMN)): Patients undergo DCE MRI prior to surgery.
  ARM III (Unresectable pancreatic cancer): Patients undergo DCE MRI before and after neoadjuvant therapy.

Eligibility: Inclusion Criteria:
  -  Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
  -  Must not have contraindication for MRI or intravenous (IV) contrast administration
  Exclusion Criteria:
  -  Allergy to intravenous contrast agents Prohance or Ferumoxytol

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.

Summary: Histological proof is a crucial and necessary step for appropriate care in oncology. In the case of pancreatic cancer, histological proof from pathological analysis of the surgical specimen is very rare due to the limited number (15-20 %) of localized tumor accessible to surgical resection. In most cases, invasive endoscopic explorations are necessary for histological diagnosis before deciding of the most appropriate treatment (palliative chemotherapy or radiochemotherapy). The endoscopic ultrasound with fine needle aspiration (EUS-FNA) is currently considered as the first-line endoscopic procedure for the cytological diagnosis of solid pancreatic tumors. The technique is performed under general anesthesia with sensitivity for the diagnosis of adenocarcinoma of 80% in case of a single procedure and 92% in situations where three different procedures are required. EUS-FNA has to be performed by a physician properly trained for this type of interventional endoscopy. Some severe complications may occur but are relatively rare in expert centers (bleeding, perforation, complications of general anesthesia ...).
  Diagnostic alternative approach is biological with research in the peripheral blood of markers of tumor disease. It is possible to detect indirect markers which are molecules produced by tumor tissue (eg CA19.9) and direct markers which reflect the presence of tumor biological material (circulating tumor cells (CTCs) or circulating tumor DNA).
  The value of detection of CTCs is not determined for the diagnostic and therapeutic management of pancreatic cancer. Indeed, no study has evaluated the diagnosis performance of circulating markers with EUS-FNA, the reference method for the diagnosis of unresectable forms.


Eligibility: Inclusion Criteria:
  -  Patient is male or female, and > 18 years of age
  -  Patient has a nonmetastatic solid pancreatic tumor (proved by CT thoraco-abdomino-pelvic) without histological evidence
  -  Patient is referred for surgical treatment or biliopancreatic endoscopic ultrasound with fine needle aspiration (EUS-FNA) of a pancreatic mass
  -  Patient has agree to participate by giving written informed consent
  Exclusion Criteria:
  -  metastatic pancreatic tumor
  -  cancer or other hematologic malignancy during treatment or in remission for less than 5 years.
  -  minor patient under 18 years
  -  contraindication to surgical treatment or contraindication to the biliopancreatic EUS-FNA
  -  patient under guardianship
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 54-year-old male with Pancreatic cancer. Genetic variant: CDKN2A. Other conditions: Diabetes, Hypertension.

Clinical trial: Tumor Registry Pancreatic Cancer

Summary: The registry aims to collect and analyse information on the antineoplastic treatment of metastatic or locally advanced pancreatic cancer in daily routine practice in Germany. The registry will follow up patients for two years. It will identify common sequences of treatments used as well as changes in the treatment of the disease. Health-related quality of life will be analysed during the course of the treatment (PanLife). Based on the available data a prognostic score will be developed.


Eligibility: Inclusion Criteria:
  -  Metastatic or locally advanced pancreatic cancer
  -  18 years and older
  -  Antineoplastic treatment
  -  Date of consent no later than 2 weeks after start of first-line treatment
  Exclusion Criteria:
  -  No pancreatic cancer
  -  Below 18 years and older
  -  No antineoplastic treatment
  -  Date of consent later than 2 weeks after start of first-line treatment

Relevance to patient case: not relevant