araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

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: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Afatinib Monotherapy in Patients With ERBB (Epidermal Growth Factor Family Receptors)-Deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Summary: Primary objective is to investigate the efficacy in terms of 6 month progression free survival (PFS6) and objective response rate (ORR) of afatinib, in patients with advanced/metastatic urothelial tract carcinoma who have progressed despite prior platinum based chemotherapy.
  Other measures of efficacy include progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of objective response (DOR), and tumour shrinkage.


Eligibility: Inclusion criteria:
  -  Recurrent or metastatic urothelial cancer
  -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  -  Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  -  Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  -  Further inclusion criteria apply
  Exclusion criteria:
  -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  -  Further exclusion criteria apply

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

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: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

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
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Prevalence of Pancreatic Anomalies of Patients With a 1st Degree Familial History of Pancreatic Adenocarcinoma

Summary: Pancreatic adenocarcinoma is the 4th leading cause of cancer in the USA. Its incidence is increasing both in France and in Europe, whereas all the other cancers are decreasing in Europe. Moreover, its seriousness is still high, with a mortality rate higher than the average incidence. The aim of PAPAFA study is to assess the prevalence of the pancreatic anomalies which can be revealed thanks to imaging, for patients having a 1st degree pancreatic adenocarcinoma familial history. This could allow detection of lesions which are less than 10 mm long, and improve the dark prognostic of this pathology.


Eligibility: Inclusion Criteria:
  -  patients with a 1st degree familial history of pancreas adenocarcinoma
  -  patients older than 40
  -  patients whose life expectancy is > 3 months
  -  inform and consent form signed
  -  patient insured under the French social security system
  Exclusion Criteria:
  -  contraindication to the MRI (pace-maker, implanted metallic material, medical history of allergy to the contrast agent, end-stage renal failure, pregnancy, claustrophobia)
  -  contraindication to anesthesia to do the echo endoscopy
  -  1st degree family history of 2 pancreas adenocarinomas
  -  medical history of allergy to benzylic alcool
  -  contraindication to dimeglumine gadobenate
  -  pregnant or breastfeeding woman, according to the questioning
  -  subjets who don't have the legal capacity to consent

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Correlation of Serum CA19-9 Levels With Levels in Saliva and Urine of Patients With Ductal Adenocarcinoma of the Pancreas

Summary: Ductal adenocarcinoma of the pancreas is the fifth leading cause of cancer related deaths in the European Union. Tumor markers CA19-9 and carcinoembryonic antigen are important components in decision making and follow-up of patients diagnosed with this disease.
  These tumor markers were found to be elevated not only in the serum but also in other body fluids in patients with malignant lesions of the parotid gland and the urinary tract. The authors have described in a previews small preliminary study a positive and a strong linear correlation between the levels of CA19-9 in urine and saliva with those presented in the serum of patients with ductal adenocarcinoma of the pancreas. The current study seeks to enlarge the study population to confirm the previous results and standardize the measured levels of CA19-9 in these body fluids.


Eligibility: Inclusion Criteria:
  Patients:
  -  Proven diagnosis of ductal adenocarcinoma of the pancreas
  -  elevated levels of CA19-9
  -  possible elevated levels of CEA
  Exclusion Criteria:
  Controls:
  -  Previous diagnosis of malignancy

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: HIPEC as Neoadjuvant Treatment for Resectable Pancreatic Adenocarcinoma

Summary: This single-center, prospective proof-of-concept study is designed to evaluate the surgical outcomes and clinicopathologic results of neoadjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) in conjunction with perioperative systemic chemotherapy (SCT; neoadjuvant and adjuvant) and pancreaticoduodenectomy (PD) in a small cohort of patients having T1-T3 resectable pancreatic ductal adenocarcinoma (PDAC) with one or more high-risk clinical features. The investigators hypothesize that HIPEC administered in this clinical course will reduce postoperative peritoneal disease recurrence. The investigators also expect that local recurrence of disease will be reduced. The primary aim of this study is to compare 2-year peritoneal disease-free survival between patients receiving the experimental therapy (neoadjuvant HIPEC + SCT + PD) with historical controls receiving standard therapy (SCT + PD). Secondary aims are to determine the clinical feasibility and outcomes of neoadjuvant HIPEC for resectable PDAC using patient demographics and disease characteristic data.


Eligibility: Inclusion Criteria:
  -  Primary diagnosis of pancreatic ductal adenocarcinoma (PDAC) confined to the head of the pancreas classified as T1-T3 with one or more of the following high-risk clinical features:
  -  Carbohydrate antigen (CA) 19-9 greater than 1,000 U/mL with a normal bilirubin;
  -  Vascular involvement; and/or
  -  Suspicious regional lymphadenopathy
  -  Intention to undergo open pancreaticoduodenectomy (standard Whipple or pylorus-preserving pancreaticoduodenectomy) as treatment for PDAC
  -  Adequate clinical condition to undergo preoperative (neoadjuvant) hyperthermic intraperitoneal chemotherapy
  -  Adequate clinical condition to undergo perioperative systemic chemotherapy
  -  White blood cell count of at least 3000/mL
  -  Platelet count of at least 100,000/mL
  -  Normal creatinine (< 2 mg/dL) or creatinine clearance of at least 50 mL/min
  -  Willing and able to give informed consent
  Exclusion Criteria:
  -  Evidence of locoregional spread (carcinomatosis of peritoneal surfaces, mesenteric arteries, or body/tail of pancreas) or distant (liver, lung, or other) metastases (histological, CT, or MRI confirmation)
  -  Non-curative intent of treatment (≥R2 resection)
  -  Body mass index (BMI) > 35
  -  Previous history of pancreatic resections for tumors in the body and/or tail of the pancreas, distal cholangiocarcinoma, duodenal carcinoma, neuroendocrine tumors, cyst-adenocarcinoma, or solid and papillary tumors.
  -  Unstable or uncompensated respiratory or cardiac disease
  -  Severe hepatic or renal dysfunction
  -  Bleeding diathesis or coagulopathy
  -  Pregnant or nursing women

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer

Summary: A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.


Eligibility: Inclusion Criteria:
  -  1. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
  -  2. Pancreatic cancer after radical resection;
  -  3. Eastern Cooperative Oncology Group Performance Status less than 2;
  -  4. Without radiotherapy or neoadjuvant chemotherapy;
  -  5. The man or the gestation and lactation women Age between 18 to 80 years old;
  -  6. Bone marrow functioned well: ANC more than 1.5*10^9/ L, PLT more than 100*10^9/LHgb more than 9 g/dL;
  -  7. Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN;
  -  8. PT and PPT are in normal ranges;
  -  9. Three months prior to clinical research did not receive any other clinical research trials;
  -  10. patients are voluntary, and willing to sign informed consent.
  Exclusion Criteria:
  -  1. Patients with other malignant tumors in the past five years;
  -  2. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
  -  3. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
  -  4. Known allergy to any kind of component of study drugs;
  -  5. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
  -  6. Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy;
  -  7. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements;
  -  8. At the same time Patients participate in any other use of interventional medicine clinical research or checkers.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer

Summary: The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.

Detailed description: In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
  So in this study, we will collect ctDNA of pancreatic cancer patients who underwent operation, and will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.

Eligibility: Inclusion Criteria:
  -  Pancreatic cancer patients who progress EUS-FNA for pancreatic cancer diagnosis
  -  Pancreatic cancer patients who are in operable stage.
  Exclusion Criteria:
  -  Foreigners
  -  Pancreatic cancer patients who have other cancer
  -  Patients who impossible to consent to study by own

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

Summary: This is an open-label, three-part, non-randomized, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer.
  The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study treatment until the end of the trial.


Eligibility: Inclusion Criteria:
  1. Has a pathologically documented advanced/unresectable or metastatic breast cancer.
  2. Eastern Cooperative Oncology Group performance status of 0 or 1.
  3. Documented HER3-positive disease measured by immunohistochemistry (IHC) (IHC 2+ or 3+).
  4. Has been treated with standard treatment, or for which no standard treatment is available.
  5. Has an Eastern Cooperative Oncology Group Performance Status 0-1.
  6. Has Left Ventricular Ejection Fraction ≥ 50%.
  7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  Additional Inclusion Criteria for Dose Finding Part and Phase 2 Part
  1. Has received 6 or fewer prior chemotherapy regimens including anthracyclines and taxanes.
  Exclusion Criteria:
  1. Prior treatment with a HER3 antibody.
  2. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201).
  3. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment.
  4. Has a medical history of myocardial infarction or unstable angina.
  5. Has a corrected QT prolongation to > 450 millisecond (ms) in males and > 470 ms in females.
  6. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
  7. Has cataracts, glaucoma, or increased intraocular pressure at baseline.

Relevance to patient case: not relevant
Patient case: 73-year-old female with Pancreatic ductal adenocarcinoma. Genetic variant: ERBB3. Other conditions: Whipple, FNA.

Clinical trial: CT Perfusion Images in Assessing Treatment Response in Patients With Pancreatic Cancer

Summary: This pilot clinical trial studies how well computed tomography (CT) perfusion images work in assessing treatment response in patients with pancreatic cancer. Analyzing specific measurements on the CT perfusion images may help doctors better determine how a tumor responds to chemotherapy and/or radiation therapy and may help guide treatment for patients with pancreatic cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To develop, test, and refine a CT perfusion protocol for its feasibility, reproducibility, and quality with a limited number of patients with a pancreatic ductal adenocarcinoma (PDA).
  II. To analyze preliminary date regarding perfusion parameters that improve accuracy in predicting response and resectability for a subset of patients with locally advanced (LA) and borderline resectable (BR) PDA treated with neoadjuvant therapy.
  OUTLINE:
  Patients undergo CT perfusion sequence over 30 seconds during the baseline standard of care CT scan and during follow-up CT scans at 2 and possibly 4 months after chemotherapy, at 4-6 weeks after radiation therapy, or prior to definitive surgery.
  After completion of the study, patients are followed up periodically for 2 years.

Eligibility: Inclusion Criteria:
  -  Signed informed consent form
  -  Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
  Exclusion Criteria:
  -  Patients unable to provide informed consent
  -  Women who are pregnant or intending to become pregnant during the study
  -  Patients with body mass index greater than 40 kg/m^2
  -  History of severe allergic-like reaction to iodinated contrast media

Relevance to patient case: not relevant