araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Vitamin K-absorption From Dairy

Summary: Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Eligibility: Inclusion Criteria:
  -  Healthy men and women between 20 and 45 years old
  -  Subjects of normal body weight and height according to BMI < 30
  -  Subjects of Caucasian race
  -  Subject has given written consent to take part in the study
  Exclusion Criteria:
  -  Subjects with (a history of) metabolic or gastrointestinal disease
  -  Subjects presenting chronic degenerative and/or inflammatory disease
  -  Abuse of drugs and/or alcohol
  -  Subjects receiving corticoid treatment
  -  Subjects using oral anticoagulants

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

Summary: In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.


Eligibility: Inclusion Criteria:
  -  Resected pancreatic ductal adenocarcinoma (PDAC)
  -  Informed consent
  Exclusion Criteria:
  -  Age < 18years
  -  Pregnancy
  -  Pre-operative radiotherapy
  -  Pre-operative chemotherapy
  -  IPMT

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Mitomycin C and Ifosfamide in Treating Patients With Metastatic Pancreatic Cancer

Summary: RATIONALE: Drugs used in chemotherapy, such as mitomycin C and ifosfamide, 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.
  PURPOSE: This phase II trial is studying how well giving mitomycin C together with ifosfamide works in treating patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To assess the therapeutic activity of a mitomycin C and ifosfamide combination, in terms of progression-free survival rate at 6 months, in patients with metastatic stage IV adenocarcinoma of the pancreas.
  OUTLINE: Patients receive mitomycin C IV on day 1 and ifosfamide IV on days 1-3. Courses repeat every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed adenocarcinoma of the pancreas
  -  Stage IV disease
  -  Metastatic disease
  -  Prior treatment with gemcitabine-based chemotherapy, also in the adjuvant setting, with progression-free survival at ≤ 12 months
  -  Measurable disease according RECIST criteria
  -  No symptomatic brain metastases
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance status 60-100% (80-100% in patients > 70 years of age)
  -  Adequate bone marrow, liver, and kidney function
  -  Not pregnant or nursing
  -  No other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms with no evidence of disease ≥ 5 years
  -  No severe comorbidities that could compromise safety, including any of the following:
  -  Cardiac failure
  -  Cardiac arrhythmia
  -  Prior myocardial infarction within the past 4 months
  -  History of psychiatric disabilities
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior mitomycin C and ifosfamide
  -  No concurrent treatment with experimental drugs

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma

Summary: We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Detailed description: Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. This leads to the increased incidence of locoregional recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.
  Methods: We will perform a prospective, non-randomized phase II study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed in the medical oncology clinic weekly. Our Primary outcome variable will be all cause postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase II study. Early termination rules include development of prohibitive toxicity or death. Our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. Exclusion criteria will include patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Eligibility: Inclusion Criteria:
  -  Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma
  Exclusion Criteria:
  -  Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

Summary: This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.


Eligibility: Inclusion Criteria:
  -  Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
  -  Patient is scheduled to receive standard chemotherapy containing gemcitabine
  -  Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
  -  Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
  Exclusion Criteria:
  -  Patient has had open abdominal surgery within 6 weeks of the screening visit
  -  Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
  -  Patient has an active infection, inflammation, or unresolved bowel obstruction
  -  Patient has poorly controlled diabetes

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Summary: The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Detailed description: Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Eligibility: Inclusion Criteria:
  -  Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required.
  -  Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter.
  -  Biochemical parameters as measured are required to be within 5 times the normal limits for age.
  -  Able and willing to follow instruction and comply with the protocol
  -  Provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score 50-100
  Exclusion Criteria:
  -  Previous removal of entire tumour
  -  Biochemical parameters as measured outside 5 times the normal limits for age
  -  Unable or unwilling to follow instructions and comply with the protocol
  -  Unable or unwilling to provide written informed consent prior to participation in the study
  -  Karnofsky Performance Scale Score < 50
  -  Nursing or pregnant females
  -  Age less than 16 years

Relevance to patient case: not relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. Other conditions: None.

Clinical trial: Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

Summary: This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed adenocarcinoma of the pancreas (When possible the tissue should be evaluated for K-ras mutation and the patient evaluated for BRCA and p16 mutations.)
  -  Locally advanced disease determined by Endoscopic ultrasound, CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
  -  No evidence of metastatic disease by CT scan (chest/abdomen/pelvis with contrast), MRI scan (of abdomen with gadolinium) or PET scan.
  -  Unresectable tumor. (this reflects those patients whose tumors abut, invade or surround a major vessel, either venous or arterial or both)
  -  No prior chemotherapy or radiation therapy.
  -  Ineligible for other high priority national or institutional studies.
  -  Negative serum or urine β-HCG within 1 week of starting treatment for non-pregnant, non-menopausal females.
  -  Must not have other underlying medical conditions that would make them ineligible for surgery, radiation therapy, or chemotherapy.
  -  Complete Blood Count and Complete Metabolic Profile:
  Absolute Neutrophil Count > 1,500 μl White Blood Count > 3,000/μl Platelet count > 100,000/μl BUN < 1.5 x normal Creatinine < 1.5 normal Hemoglobin > 8.0 g/dl Serum Albumin > 3 mg/dl Total Bilirubin < 3.0 mg/dl SGOT, SGPT, Alkaline Phosphatase < 2.5 x ULN
  -  Informed consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the nature of this therapy, alternatives, potential benefits, side-effects, risks, and discomforts.

Relevance to patient case: definitely relevant
Patient case: 57-year-old female with Pancreatic adenocarcinoma. Genetic variant: RB1, TP53, KRAS. 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