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

Clinical trial: Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas

Summary: This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.

Detailed description: Primary objective:
  -  Evaluation of the prognosis role of the invasion of the margins on the overall survival after a standard resection of adenocarcinoma of the head of the pancreas.
  Secondary objectives:
  -  Evaluation of the prognosis role of the invasion:
  -  Of margins on the overall survival.
  -  Of each margins (distal pancreatic margin, gastric, posterior, retro-venous, retro-arterial) on the overall survival.
  -  Of the ganglionic group of the superior mesenteric artery and the other nodes.

Eligibility: Inclusion Criteria:
  -  A head of the pancreas tumor compatible with adenocarcinoma diagnosis
  -  tumor apparently removable
  -  patient aged from 18 to older
  -  signed consent
  Non inclusion criteria:
  -  pregnancy, breast feeding
  -  patient in an urgency situation or patient with legal protection
  Exclusion Criteria after surgery:
  -  tumor other than adenocarcinoma of the head of the pancreas.
  -  analysis of the margins not done with the defined criteria
  -  nonadhesion to the surgical protocol

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 (GFF) in Patients With Pancreatic Cancer

Summary: The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

Detailed description: This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

Eligibility: Inclusion Criteria:
  -  histological proved pancreatic cancer
  -  inoperable disease
  -  informed consent
  -  adequate bone marrow reserve
  Exclusion Criteria:
  -  under 18 years
  -  brain metastasis
  -  lactating woman
  -  life expectancy under 3 months

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

Clinical trial: Parenteral Nutrition Support for Patients With Pancreatic Cancer

Summary: The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

Detailed description: To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  histological proved pancreatic cancer
  -  progressive cancer cachexia
  -  refractive to enteral supplementation
  -  informed consent
  Exclusion Criteria:
  -  prefinal status
  -  septic 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: Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Summary: The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Age older than 18
  -  Younger than 75
  -  ECOG performance status 0 or 1
  -  Histologically confirmed adenocarcinoma of the pancreas
  -  Metastatic pancreatic cancer
  -  No prior chemotherapy for metastatic pancreatic cancer
  -  A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)
  Exclusion Criteria:
  -  A patient with no measurable disease
  -  A patient who received previous palliative chemotherapy for pancreatic cancer
  -  A patient with locally advanced pancreatic cancer
  -  A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
  -  A patient with previous active or passive immunotherapy
  -  A pregnant or lactating patient

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

Clinical trial: Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Summary: The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

Detailed description: Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Eligibility: Inclusion Criteria:
  1. Age > 18 years
  2. Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
  3. ECOG performance status of 0~2
  4. no radiotherapy within 1 month of the study entry
  5. measurable or evaluable lesion according to RECIST criteria
  6. no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
  7. adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
  8. written informed consent must be provided
  Exclusion Criteria:
  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
  4. known history of hypersensitivity to study drugs
  5. patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry

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

Clinical trial: Influence of Gemcitabine Treatment on Immunological and Serological Profile in Patients With Pancreatic Cancer

Summary: Observational study of influence of gemcitabine treatment on serological and immunological status and gene expression profile in patients with pancreatic tubular carcinoma after tumor resection.


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2 at the time of inclusion
  -  Following R0 or R1 pancreatic tubular adenocarcinoma resection
  Exclusion Criteria:
  -  Pregnancy
  -  Serious comorbidity

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

Clinical trial: Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, capecitabine, gemcitabine hydrochloride, epirubicin hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether cisplatin, capecitabine, and gemcitabine hydrochloride are more effective when given together with epirubicin hydrochloride or docetaxel in treating patients with advanced or metastatic pancreatic cancer.
  PURPOSE: This randomized phase II trial is studying the side effects of giving cisplatin, capecitabine, and gemcitabine hydrochloride together with epirubicin hydrochloride compared with giving cisplatin, capecitabine, and gemcitabine hydrochloride together with docetaxel and to see how well it works in treating patients with stage III or stage IV pancreatic cancer.

Detailed description: OBJECTIVES:
  -  Assess 6-months progression-free survival of patients with stage III or IV adenocarcinoma of the pancreas treated with cisplatin, capecitabine, gemcitabine hydrochloride (PXG) and epirubicin hydrochloride vs PXG and docetaxel.
  -  Evaluate the activity and toxicity of these regimens in these patients.
  OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 arms.
  -  Arm I (PEXG): Patients receive cisplatin, gemcitabine hydrochloride, and docetaxel on days 1 and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  -  Arm II (PGDX): Patients receive cisplatin, gemcitabine hydrochloride, and epirubicin hydrochloride on days 1and 15, and capecitabine on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  Patients may then undergo surgery if the tumor becomes resectable.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the pancreas
  -  Stage III or IV disease
  -  Measurable disease
  -  No symptomatic brain metastases
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100%
  -  Adequate bone marrow, liver, and kidney function
  -  Not pregnant or nursing
  -  No other malignancies within the past 5 years except surgically treated carcinoma in situ of the cervix, and basal or squamous cell carcinoma of the skin
  -  No multiple severe diseases that can compromise study safety, including any of the following:
  -  Cardiac failure
  -  Myocardial infarction within the past 4 months
  -  Cardiac arrhythmia
  -  History of psychiatric disabilities
  PRIOR CONCURRENT THERAPY:
  -  No prior chemotherapy or radiotherapy for pancreatic cancer
  -  No other concurrent experimental drugs

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

Clinical trial: Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer

Summary: The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.

Detailed description: The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.
  The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2

Eligibility: Inclusion Criteria:
  1. Male or Female
  2. Age ≥19 yrs old
  3. Abdominal pain typical for pancreatic cancer ≥3/10
  4. Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
  5. Pancreatic cancer confirmed by FNA during EUS
  6. Inoperability of pancreatic cancer as determined during EUS or prior CT
  Exclusion Criteria:
  1. Age < 19 yrs old
  2. Unable to safely undergo EUS for any reason
  3. Coagulopathy (prolongation of prothrombin time > 18 sec, thrombocytopenia <80,000 platelets/ml)
  4. Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
  5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
  6. Potential patient noncompliance (refusing to follow schedule of events)
  7. Active alcohol or other drug use or significant psychiatric illness
  8. Pregnant or breastfeeding
  9. Unable to consent
  10. Non-English speaking

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

Clinical trial: Using Video Images to Improve Advance Care Planning in Patients With Cancer

Summary: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone.

Detailed description: The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone. Subjects will choose among three goals of care, life prolonging care, basic medical care, and comfort care.

Eligibility: Inclusion Criteria:
  1. Terminal, progressive cancer with poor prognosis whose treatment intent is palliative, based on the following definition:
  -  All patients with brain cancer, liver cancer, inoperable non-small cell lung carcinoma, pancreatic cancer, or gallbladder cancer; OR
  -  Patients with the following cancers: metastatic colon cancer or stage III or IV non-small cell lung cancer; OR
  -  Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, stomach cancer, esophageal cancer, melanoma, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma.
  -  The terms terminal, progressive, poor prognosis, palliative intent and limited response will be judged by the patient's oncologist (and not by the RSA or consenting professional).
  2. Return patient visit (defined as a patient known to the oncologist from previous assessments and treatments, where the working and personal relationship has been established and not a new patient to the clinic).
  3. English speaking. Only English-speaking patients will be included in our present study since English is the validated language of our study tools.
  4. Given the sensitive nature of the study, clinicians will decide whether the patient is a potentially appropriate subject based on their knowledge of the patient.
  5. Able to provide informed consent.
  6. Age greater than or equal to 21.
  Exclusion Criteria:
  1. MMSE < 25.
  2. Psychological state not appropriate for end-of-life discussion as determined by the treating clinician.

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 Blood Samples From Patients With Malignant Melanoma, Metastatic Breast Cancer, Advanced Lung Cancer, Pancreatic Cancer, or Colorectal Cancer. ICORG 07-12

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in peptides and proteins and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at blood samples from patients with malignant melanoma, metastatic breast cancer, advanced lung cancer, pancreatic cancer, or colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To assess which potential peptide and protein markers produced by human melanoma, lung, breast, pancreatic, and colorectal cell lines may be detectable in serum of patients from these five disease groups.
  Secondary
  -  To conduct further extensive investigation with respect to identification of the protein/peptide involved, determination of specificity for each cancer, and development of more sensitive assays to look for such markers in a wider population of patients, including those undergoing therapy.
  OUTLINE: This is a multicenter study.
  Blood samples are collected before surgical intervention or treatment to assess peptide and protein markers.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of 1 of the following advanced metastatic malignancies:
  -  Malignant melanoma
  -  Lung cancer
  -  Breast cancer
  -  Pancreatic carcinoma
  -  Colorectal cancer
  -  Advanced and/or metastatic disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Summary: This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

Detailed description: This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  -  Predicted life expectancy of >= 12 weeks
  -  Previous surgery
  -  Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
  -  No prior therapy for pancreatic cancer
  -  Adequate organ and marrow function
  -  Absolute neutrophil count >= 1.5 x 10^9/L
  -  Platelets >= 100 x 10^9/L
  -  Total bilirubin <= institutional upper limits of normal
  -  AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
  -  Serum creatinine <= 1.5 x upper limits of normal
  -  Negative pregnancy test
  -  Informed consent
  -  Patient must agree not to smoke while on study
  Exclusion Criteria:
  -  Significant history of cardiac disease unless the disease is well controlled
  -  Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
  -  History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
  -  History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
  -  Pregnant or breast-feeding females
  -  Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
  -  History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs

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

Clinical trial: Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma

Summary: Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.


Eligibility: Inclusion Criteria:
  -  ECOG performance status 0-2 at the time of inclusion
  -  Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment
  Exclusion Criteria:
  -  Pregnancy
  -  Less than 3 mths expected survival
  -  Serious comorbidity
  -  Age above 70 yrs

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

Clinical trial: Comparison of Secretin-enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) to Endoscopic Pancreatic Function Test (ePFT) in Diagnosing Pancreatic Exocrine Insufficiency

Summary: The aim of our study is to evaluate S-MRCP, in comparison to direct pancreatic function, to measure pancreatic exocrine function in patients who have symptoms suspicious for insufficiency. We hypothesize that S-MRCP imaging parameters will correlate well with the direct pancreatic exocrine functioning.

Detailed description: Surgical resection offers the only hope of cure for pancreatic adenocarcinoma. While perioperative mortality rates have declined in recent years, pancreatic resection is still associated with significant postoperative malnutrition, maldigestion, and glucose intolerance, mostly as a result of pancreatic insufficiency. Quantifying individual pancreatic function remains a challenge, but is essential in improving the survival and quality of life of pancreatic cancer patients. Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) has recently emerged as a widely-accepted noninvasive technique to assess morphological changes in pancreatic ducts, as well as functional secretory capacity of the gland. The aim of our study is to evaluate S-MRCP as a means to evaluate for pancreatic exocrine insufficiency. This will be a prospective study of twelve patients who have undergone pancreatic resection and who have symptoms of abdominal pain, steatorrhea or weight loss. We will be comparing quantitative parameters of S-MRCP (maximal change in pancreatic duct diameter and volume before and after secretin administration) with endoscopic pancreatic function testing (maximal bicarbonate concentration in duodenal aspirate after secretin administration).

Eligibility: Inclusion Criteria:
  -  18 years of age and older
  -  Tissue-confirmed diagnosis of pancreatic adenocarcinoma
  -  Undergone surgical resection for adenocarcinoma no less than 3 months prior to enrollment
  -  Report significant abdominal pain/bloating or steatorrhea >3x/week or demonstrate weight loss corresponding to >10% of pre-surgery BMI.
  -  Scheduled for EGD/EUS to investigate the above clinical indicators.
  Exclusion Criteria:
  -  History of any radiation therapy to the abdomen prior to surgery
  -  Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator, cochlear implants, or metal in the eye)
  -  Presence of pancreatic duct stent
  -  Treatment with an investigational drug within 1 month prior to the day of the study drug administration
  -  Current enrollment in any other interventional study
  -  Creatinine greater than 2.0
  -  Significant liver disease, liver masses, or evidence of portal hypertension
  -  Pregnancy
  -  History of sensitivity to secretin
  -  Unwilling or unable to sign informed consent

Relevance to patient case: not relevant