araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

Summary: This phase I/II trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging and to see how well they work in finding pancreatic cancer in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a special imaging device.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the efficacy of cetuximab IRDye800 (cetuximab-IRDye 800CW) in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.
  SECONDARY OBJECTIVES:
  I. To determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.
  OUTLINE: This is a dose-escalation study.
  Patients receive cetuximab-IRDye 800CW intravenously (IV) over 30 minutes to 1 hour on day 0. Within 2-5 days, patients undergo surgery with intraoperative imaging.
  After completion of study treatment, patients are followed up at days 10 and 30.

Eligibility: Inclusion Criteria:
  -  Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
  -  Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
  -  Life expectancy of more than 12 weeks
  -  Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1
  -  Hemoglobin >= 9 gm/dL
  -  Platelet count >= 100,000/mm^3
  -  Magnesium, potassium and calcium > the lower limit of normal per institution normal lab values
  -  Thyroid-stimulating hormone (TSH) < 13 micro International units/mL
  Exclusion Criteria:
  -  Received an investigational drug within 30 days prior to first dose of cetuximab IRDye800
  -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
  -  History of infusion reactions to cetuximab or other monoclonal antibody therapies
  -  Pregnant or breastfeeding
  -  Patients who have a serious reaction with the test/loading cetuximab dose for which they were not able to receive the full dose
  -  Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
  -  Lab values that in the opinion of the primary surgeon would prevent surgical resection
  -  Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas

Summary: Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.

Detailed description: The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.

Eligibility: Inclusion Criteria:
  1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
  2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study.
  3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).
  4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age.
  5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization):
  -  Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
  -  Platelet count ≥ 100,000/mm3 (100 × 10^9/L)
  -  Hemoglobin (Hgb) ≥ 9 g/dL.
  6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization):
  -  AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed.
  -  Total bilirubin ≤ULN
  7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.
  8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
  Exclusion Criteria:
  1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
  2. Patients have uncontrolled bacterial, viral, or fungal infections
  3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.
  4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.
  5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.
  6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Study of Changes and Characteristics of Genes in Patients With Pancreatic Cancer for Better Treatment Selection

Summary: Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.


Eligibility: Inclusion Criteria:
  -  Patients must have a histological or radiological diagnosis of locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with borderline resectable disease are not eligible.
  -  Patient must have a tumor lesion that is amenable to a core needle biopsy.
  -  Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
  -  Patients must be fit enough to safely undergo a tumor biopsy.
  -  Age 18 years or older.
  -  Eastern Cooperative Group (ECOG) performance status of 1 or less.
  -  Life expectancy of greater than 90 days.
  -  Patients must have normal organ and marrow function
  -  Patients must undergo systemic treatment with m-FOLFIRINOX or nab-paclitaxel as a first line standard systemic palliative treatment or combination treatment with m-FOLFIRINOX or nab-paclitaxel with or without other investigational agents within a clinical trial as a first line palliative treatment.
  -  Ability to understand and willing to sign a written informed consent document.
  Exclusion Criteria:
  -  Patients with one or more contraindications to tumor biopsy.
  -  Patients who have prior systemic treatment (chemotherapy or any other anti-cancer agent) in advanced setting.
  -  Patients who are currently on anti-cancer treatment including chemotherapy.
  -  Patients with known brain metastases.
  -  Patients with advanced PDAC who are going to be treated with gemcitabine monotherapy in advanced setting.
  -  Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  -  Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

Summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

Detailed description: The study will be proposed to all patients with a metastatic colorectal cancer.
  Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
  Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility: Inclusion Criteria:
  -  Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
  -  Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  -  Age : 18 years and older
  Exclusion Criteria:
  -  Patient bearing non-metastatic colorectal cancer
  -  Patient with local relapse only
  -  Patient with exclusive nodal metastases
  -  Patient whose health contraindicates a 30 ml blood sample
  -  Blood transfusion within 1 week prior blood collection
  -  Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
  -  History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
  -  Persons deprived of liberty or under supervision

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes

Summary: Adjuvant Gemcitabine Versus Gemcitabine With Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection.

Detailed description: Adjuvant Gemcitabine Versus Gemcitabine With TS-1 based Chemoradiation in Pancreatic Adenocarcinoma With R1 Resection and/or Positive Lymph Nodes after curative resection: a randomized phase II study.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed resected ductal pancreatic adenocarcinoma with R1 resection and/or positive lymph nodes.
  -  Subject should start treatment no later than 10 weeks postsurgery.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  -  Acceptable hematology parameters:
  -  Absolute neutrophil count ≥1500 cell/mm3
  -  Platelet count ≥100,000/mm3
  -  Hemoglobin (Hgb) ≥8.0 g/dL
  -  Acceptable blood chemistry levels:
  -  Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × upper limit of normal range (ULN)
  -  Total bilirubin ≤ 2.5 x upper Limit of Normal (ULN)
  -  Serum creatinine within upper limits of normal.
  -  Cancer antigen (CA)19-9 ≤ 2.5 x upper Limit of Normal (ULN) assessed within 14 days of randomization.
  -  No disease recurrence or metastases detected on CT/MRI assessed within 30 days of randomization.
  -  Signed informed consent.
  Exclusion Criteria:
  -  R2 resection or presence of metastatic disease.
  -  Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma.
  -  Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
  -  Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
  -  Severe, active co-morbidity, defined as follows:
  -  Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  -  Transmural myocardial infarction within the 6 months of study registration
  -  Uncontrolled hypertension, diabetes or arrhythmia.
  -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
  -  Not able to take medicine orally.

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor.

Summary: The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax monotherapy in approximately 250 participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.


Eligibility: Inclusion Criteria:
  -  Participant has Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
  -  Participant has relapsed/refractory disease (received at least 1 prior therapy)
  -  Participant has diagnosis of CLL that meets published 2008 Modified IWCLL NCI-WG Guidelines and:
  -  has an indication for treatment according to the 2008 Modified IWCLL NCI-WG criteria
  -  has clinically measurable disease (lymphocytosis greater than 5 × 109/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
  -  In addition, participants:
  -  may harbor 17p deletion or TP53 mutation, assessed by a local laboratory in bone marrow or peripheral blood AND/OR
  -  may have been previously treated with a prior B-cell receptor inhibitor
  -  Participant must have adequate bone marrow function, coagulation profile, renal, and hepatic function, per laboratory reference range at Screening
  Exclusion Criteria:
  -  Participant has developed Richter's transformation or Prolymphocytic leukemia
  -  Participant has previously received venetoclax
  -  History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
  -  adequately treated in situ carcinoma of the cervix uteri
  -  adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
  -  previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
  -  Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura despite low dose corticosteroids
  -  Participant has undergone an allogeneic stem cell transplant grade 2:
  -  Any anti-cancer therapy including chemotherapy, or radiotherapy;
  -  Investigational therapy, including targeted small molecule agents
  -  Participant is human immunodeficiency virus (HIV) positive
  -  Participant has known allergy to both xanthine oxidase inhibitors and rasburicase

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma

Summary: This is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two magnetic resonance imaging (MRI) scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Parameters will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.

Detailed description: This is a prospective cohort study of dynamic contrast enhanced MRI (DCE-MRI), which includes diffusion weighted imaging (DWI-MRI) in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two MRI scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Quantitative parameters of volume transfer coefficient (Ktrans) and apparent diffusion coefficient (ADC) will be calculated from the MRI sequences and each parameter will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The influence of the contrast agent (extracellular and macromolecular) on agreement between imaging parameters and histopathology will be assessed and agreement in Ktrans as derived from a one compartment and a two-compartment model will be assessed. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.

Eligibility: Inclusion Criteria:
  1. > 18 years of age.
  2. Biopsy proved pancreatic ductal adenocarcinoma (PDA) and/or a pancreatic mass with imaging features suggestive of pancreatic adenocarcinoma planned for surgical resection.
  3. No contraindication to MRI such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (MR) compatible at 1.5 Tesla (departmental MRI safety screening form)
  4. No known allergy to gadolinium based contrast agent
  5. Patient has an estimated glomerular filtration rate (GFR) >30 mg/dL using the modification of diet in Renal Disease (MDRD) formula.
  Exclusion Criteria:
  1. Contraindication to MR imaging
  2. Pregnancy

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Lymphadenectomy for Pancreatic Head Cancer: Standard or Extended?

Summary: The purpose of this study is to compare outcomes of patients undergoing standard or extended lymphadenectomy in pancreaticoduodenectomy for pancreatic cancer


Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of pancreatic ductal adenocarcinoma
  -  Signed the informed consents
  Exclusion Criteria:
  -  Pathologic diagnosis of other pancreatic cancers
  -  Pre-operative anti-cancer treatment
  -  Recurrence patients
  -  Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
  -  Pre operative exam: Total bilirubin more than 250µmol/L
  -  AJCC stage IV
  -  Operation non radical

Relevance to patient case: not relevant
Patient case: 49-year-old female with Pancreatic adenocarcinoma. Genetic variant: KRAS, TP53. Other conditions: None.

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant