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: BrUOG 278: FOLFOX-A For Pancreatic Cancer A Brown University Oncology Research Group Study

Summary: The purpose of this study is to test the safety, activity and best doses of FOLFOX-A which consists of the standard chemotherapy drugs fluorouracil, leucovorin, oxaliplatin and abraxane. Each of these drugs are currently used in pancreatic cancer.
  The experimental part of the study is combining these drugs together in FOLFOX-A.

Detailed description: More active treatments are desperately needed in pancreatic cancer. The regimen of FOLFIRINOX increases survival as compared to gemcitabine but at a cost of increased toxicity. Irinotecan is responsible for much of the toxicity of FOLFIROX but may not contribute significantly to the regimen's activity. Abraxane is a new agent in pancreatic cancer. This albumin-bound nanoparticle form of paclitaxel increases tumor accumulation of paclitaxel though binding of albumin to SPARC in pancreatic cancer stroma. The investigators therefore propose a pilot study of FOLFOX (fluorouracil, leucovorin and oxaliplatin) combined with abraxane to establish the safety and preliminary activity of FOLFOX-A. Patients with inoperable (metastatic and locally advanced) pancreatic cancer will be eligible since the primary outcome is to establish the safety of FOLFOX-A.

Eligibility: Inclusion Criteria:
  -  Pathologically confirmed pancreatic ductal adenocarcinoma.
  -  Metastatic or locally advanced disease.
  -  No prior treatment for pancreatic cancer
  -  Radiographically measurable disease.
  -  No major surgery within 4 weeks of the start of study treatment. Patients must have recovered from the side effects of any major surgery at the start of study treatment. Laparoscopy and central venous catheter placement are not considered major surgery.
  -  Patients with serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive FOLFOX-A
  -  Preexisting neuropathy > grade 1.
  -  No prior invasive malignancy within the prior two years. However, patients with an early stage malignancy that is not expected to require treatment in the next 2 years (such as early stage, resected breast cancer or asymptomatic prostate cancer) are eligible.
  -  ECOG performance status 0 or 1.
  -  Age ≥ 18 years of age.
  -  Not pregnant and not nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to beginning of treatment.
  -  Required Initial Laboratory Values:
  -  Neutrophils ≥ 1,500/μl
  -  Platelet count ≥ 100,000/μl
  -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min
  -  Total bilirubin ≤ 1.5 x ULN
  -  AST (SGOT) & ALT (SGPT) ≤ 3.0 x ULN
  Exclusion Criteria:
  -Patients with known brain metastases

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: Intraoperative Imaging of Breast Cancer With Indocyanine Green

Summary: According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.


Eligibility: Inclusion Criteria:
  1. Adult patients over 18 years of age
  2. Women with newly diagnosed, operable invasive ductal carcinoma, invasive lobular carcinoma or ductal carcinoma who are deemed breast conservation surgery candidates (i.e. lumpectomy +/- sentinel node biopsy).
  3. Breast cancer needs to be unifocal as determined by clinical parameters, e.g. by palpation or by breast imaging findings including mammogram, US and/or breast MRI. Multifocal disease, i.e. cancer confined to one quadrant, is eligible if patients are deemed breast conservation candidates.
  4. Subject capable of giving informed consent and participating in the process of consent.
  Exclusion Criteria:
  1. Newly diagnosed breast cancer patients who are not breast conservation candidates and those with multicentric breast cancer (breast cancer documented in multiple quadrants by breast imaging or exam)
  2. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery
  3. Subjects with a history of iodide allergies
  4. At-risk patient populations
  1. Homeless patients
  2. Patients with drug or alcohol dependence
  3. Patients unable to participate in the consent process

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: Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm

Summary: This study will test two different needles for performing a biopsy of the pancreas during endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The purpose of this study is to compare which of the two needles is better for performing biopsies of the pancreas on masses that are greater than 35mm.

Detailed description: Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25, 22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and perform equally well. However, in a retrospective study, the diagnostic sensitivity of EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size masses. This is because larger size tumors have more necrosis and it is difficult to identify cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in larger size tumors to establish a diagnosis. In previous studies it has been shown that the larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be achieved with fewer passes.

Eligibility: Inclusion Criteria:
  All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions greater than 35 mm on computed tomography (CT) that require FNA.
  Exclusion Criteria:
  -  Age < 19 years
  -  Unable to safely undergo EUS for any reason
  -  Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
  -  Unable to consent
  -  Non-English speaking patients
  -  Participation in any other clinical trial (excluding registries or databases)

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: Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Summary: To study the safety and efficacy of the combination of LJM716 and BYL719 against currently available treatments of physician's choice in previously treated esophageal squamous cell carcinoma patients.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed esophageal squamous cell carcinoma (ESCC)
  -  No more than one prior chemotherapy regimen for recurrent or metastatic ESCC (for Phase II only).
  -  Progression during or after platinum-based therapy for recurrent or metastatic ESCC, or recurrence within 6 months of platinum-based chemotherapy or chemoradiotherapy for localized disease.
  Exclusion Criteria:
  -  Patients who received prior phosphoinositide-3-kinase (PI3K) inhibitor or anti-receptor tyrosine-protein kinase erbB-3 (ERBB3 or HER3) antibody treatment, including bi-specific antibodies with HER3 as one of the targets (patients with prior exposure to pertuzumab or epidermal growth factor receptor (EGFR)-targeted agents are eligible)
  -  Patients who do not have an archival or fresh tumor sample (or sections of it) available or readily obtainable.
  -  Patients with central nervous system (CNS) metastatic involvement.
  -  Patients who have received prior systemic anti-cancer treatment, such as cyclical chemotherapy or biological therapy within a period of time that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment.
  -  Patients who have received definitive radiotherapy ≤ 4 weeks prior to starting study drug, who have not recovered from side effects of such therapy and/or from whom ≥ 30% of the bone marrow was irradiated.
  -  Other protocol-defined inclusion/exclusion criteria may 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: Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer

Summary: Background:
  Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate diagnosis of a pancreatic mass is important to direct patient management. Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To overcome these limitations, a new needle device with ProCore reverse-bevel technology was developed recently.
  Aims:
  The objective of this prospective study is to compare the rate of diagnostic sufficiency in the EUS sampling by using newly developed ProCore needle with conventional FNA needle in suspected unresectable pancreatic cancer. We will also compare the safety, the yield of histologic core tissue and the cost-effectiveness between these modalities.

Detailed description: Patient:
  Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in diagnostic imaging such as CT or MRI
  Procedure:
  Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority of order will be given by randomization assignment.
  The number of patients required:
  Total sixty five patients will be required.

Eligibility: Inclusion Criteria:
  -  Patients who agree to participate in research
  -  18 years of age and older patients less than 80 years old
  -  Patients who have suspected unresectable pancreatic cancer in imaging studies
  Exclusion Criteria:
  -  Contraindication to endoscopy
  -  Patients younger than 18 years old or older than 80 years old
  -  Bleeding tendency
  -  Cardiopulmonary dysfunction
  -  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: Pilot Study Evaluating Broccoli Sprouts in Advanced Pancreatic Cancer [POUDER Trial]

Summary: The goal of the POUDER trial is to determine the feasibility of a randomized controlled trial regarding the application of freeze-dried broccoli sprouts rich in sulforaphane and quercetin in patients with advanced pancreatic ductal adenocarcinoma that receive palliative chemotherapy.

Detailed description: Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.

Eligibility: Inclusion Criteria:
  -  Advanced, surgically non-treatable pancreatic ductal adenocarcinoma (surgical exploration, intraoperative biopsy but also palliative bypass interventions (bileodigestive anastomosis and/or gastroenterostomy because of preoperative cholestasis or impaired gastric emptying due to tumor-mass effect)
  -  Intact gastric emptying
  -  Written informed consent
  -  Patients ≥18 years of age
  -  Palliative chemotherapy
  Exclusion Criteria:
  -  Intolerance to broccoli or its ingredients
  -  Impaired mental status or language problems / barriers

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: Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas

Summary: The p63 gene is a recently discovered member of the p53 family located at chromosome 3q27Many studies have reported that overexpression of p63 can mimic p53 activities by binding DNA, activating transcription, and inducing apoptosis.
  Various studies proved p63 as a marker of basal cells in normal salivary glands, breast, prostate, respiratory and squamous epithelia, and of tumor cells from various malignancies. Still, p63 has been the subject of relatively few studies in lung adenocarcinoma, and breast carcinoma, and no study has described the correlation of p63 with pancreatic ductal adenocarcinoma.
  In the current study, we aim to evaluate the prognostic value of the expression of p63 in the lung adenocarcinoma, breast adenocarcinoma, and pancreatic ductal adenocarcinoma. We will achieve this aim by collecting clinical data retrospectively from the patients' medical records as well as assessing the histological sections and performing immunohistochemical staining for p63.


Eligibility: Inclusion Criteria:
  -  Patients who were treated at our institution for lung adenocarcinoma, breast adenocarcinoma, or pancreatic ductal adenocarcinoma.
  -  Available histopathological diagnosis of the malignancy.
  Exclusion Criteria:
  -  Patients with inoperable tumors.
  -  Patients with second primary tumor.
  -  Patients with pathological blocks not enough for future slicing.

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: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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

Clinical trial: Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer

Summary: The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.


Eligibility: Inclusion Criteria:
  -  subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
  -  subject must have adequate renal function
  -  ECOG performance status of 0-2
  -  women of child-bearing age and men must agree to use contraception prior to and during the study
  Exclusion Criteria:
  -  subjects receiving any other investigational agents
  -  significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
  -  pregnant or breastfeeding 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: Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

Summary: Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.


Eligibility: Inclusion Criteria:
  -  Males and females >=18 years of age (at the time consent is obtained).
  -  Written informed consent provided.
  -  Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Sufficient archival tumor specimen is available for HER3 immunohistochemistry (IHC) analysis, or subject is willing to undergo a fresh tumor biopsy for HER3 IHC analysis.
  -  Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx).
  Exclusion Criteria:
  -  Subjects with leptomeningeal or brain metastases or spinal cord compression.
  -  Prior HER3- directed treatment (HER2- or EGFR-directed treatment is acceptable).
  -  Concurrent medical condition that would jeopardize compliance.
  -  Receiving chronic immunosuppressive therapies (includes daily steroid doses in excess of 20 milligrams [mg]/day of prednisone).

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: Efficiency Study of the EUS-FNA Needles With and Without a Side Port in Pancreatic Masses

Summary: For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. We hypothesize that a FNA needle with a side port could improve the diagnostic yield. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield in patients with pancreatic masses for evaluation.

Detailed description: For diagnosis of pancreatic tumors, endoscopic ultrasound (EUS) and EUS-guided fine needle aspiration (EUS-FNA) are well established techniques in clinical practice. In the case of EUS, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, and also enables detailed images of areas outside of the digestive tract. EUS has a significant clinical impact because it allows assessment of submucosal GI lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by EUS-FNA and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. In prospective trials, EUS-FNA has been clearly established to be an important diagnostic tool with excellent safety profile.
  Olympus has recently made commercially available a new 22 gauge FNA needle with a side port at the needle tip to facilitate the process of FNA and increase the diagnostic yield. There have been preliminary unpublished retrospective data that suggested the yield might be raised. However, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. The aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between EZ-Shot 2 (model: NA-220H-8022) and EZ-Shot 2 with side port (NA-230H-8022) in patients with pancreatic masses for evaluation. We hypothesize that a FNA needle with a side port could improve the diagnostic yield.

Eligibility: Inclusion criteria:
  1. all patients referred for EUS-FNA of pancreatic masses;
  2. informed consent is obtained for performance of EUS-FNA.
  Exclusion criteria:
  1. presence of active gastrointestinal bleeding

Relevance to patient case: not relevant