araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Gefitinib and Berberine in the First-line Treatment of Lung Adenocarcinoma With EGFR Mutation

Summary: Rationale:
  Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators hypothesize that progression-free survival could be improved by combination of gefitinib and berberine.

Detailed description: Strong lipogenic activity and high expression of sterol regulatory element-binding protein 1 (SREBP-1) were found in gefitinib-resistance NSCLC cells. Berberine, an effective suppressor of SREBP1 and lipogenesis regulated through ROS/AMPK pathway, selectively inhibited the growth of gefitinib-resistance NSCLC cells but not that of normal cells. It effectively caused mitochondrial dysfunction, activated reactive oxygen species (ROS)/AMPK pathway and finally suppressed cellular lipogenesis and cell proliferation. Addition of ROS blocker, AMPK inhibitor and palmitic acid significantly reduced the effect of Berberine. In in vivo study, treatment of Berberine led to significant inhibition of mouse tumor xenograft growth.

Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years
  -  ECOG performance status 0-2
  -  Adequate haematological function, coagulation, liver function and renal function
  -  Pathological diagnosis of predominantly non-squamous, non-small-cell lung cancer (NSCLC)
  -  TNM version 7 stage IV disease including M1a (malignant effusion) or M1b (distant metastasis), or locally advanced disease not amenable to curative treatment (including patients progressing after radiochemotherapy for stage III disease)
  -  Measurable or evaluable disease (according to RECIST 1.1 criteria).
  -  Centrally confirmed EGFR exon 19 deletion (del19) or exon 21 mutation (L858R)
  Exclusion Criteria:
  -  Patients who have had in the past 5 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma.
  Patients with any known significant ophthalmologic anomaly of the ocular surface
  -  Patients who received prior chemotherapy for metastatic disease
  -  Patients who received previous treatment for lung cancer with drugs targeting EGFR or VEGF
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Genetic Testing for Men With Metastatic Prostate Cancer

Summary: This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. The researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. Neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.

Detailed description: PRIMARY OBJECTIVES:
  I. To assess the frequency of pathogenic germline homologous recombination (HR) variants in men with metastatic prostate cancer (mPC).
  II. To collect patient reported outcome measures associated with genetic testing in men with mPC.
  III. To assess the utility of family history to enrich screening of population of men with metastatic prostate cancer for germline HRD variants.
  IV. To identify a cohort of men with prostate cancer and inherited homologous recombination deficiency (HRD) mutations who might benefit from specific research and treatment opportunities and provide a mechanism to notify these men of current and future opportunities.
  OUTLINE:
  Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.
  After study completion, participants are followed up at 6 months.

Eligibility: Inclusion Criteria:
  -  Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research trial information
  -  Documented evidence of metastatic prostate cancer;
  -  Oncologist note within 4 months
  -  All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months
  -  All prostate-specific antigen (PSA) values within 12 months
  -  All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy
  -  Willingness to provide basic demographic information, family cancer history, and treatment history
  -  Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up
  -  Willingness and ability to provide saliva sample
  Exclusion Criteria:
  -  Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
  -  Incomplete inclusion criteria
  -  Study team members

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Cannabis Oil for Pain Effectiveness

Summary: This project represents a first systematic, prospective, single-arm cohort study of a safe and effective dosing regimen of an orally administered cannabis oil formulation in a cancer subject population with poorly controlled pain.

Detailed description: Over a 1-2 year period, 40 cancer patients experiencing poorly controlled pain will be enrolled in to a prospective single-arm cohort study, in which they will receive an orally administered cannabis oil formulation as an add-on therapy to current treatment regimens. Subjects entering the acute study phase will be titrated to a tolerated dose at which a sustained pain response is reached, and may subsequently enter a 12 week chronic phase during which safety and durability of pain response will be assessed at their stable dose.

Eligibility: Inclusion Criteria:
  1. Men and women with breast, prostate or gastrointestinal cancer who have poorly controlled pain defined by the use of three or more PRN, or as needed, doses of opioids in a 24-hour period for a minimum of three days per week in the week prior to study registration.
  2. Age 25-70 years.
  3. An ESAS score of 2 or more recorded as their worst pain at the time of study registration.
  Exclusion Criteria:
  1. Current use of cannabis within the last 30 days from date of study consent (urine screen test positive).
  2. Brain metastases.
  3. ECOG performance > 2.
  4. Life expectancy < 6 months.
  5. Daily morphine milligram equivalent (MME) dose < 15 or > 120.
  6. Current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent or psychosis that could be exacerbated by the administration of cannabis.
  7. Chemotherapy induced neuropathy.
  8. Poorly controlled hypertension, unstable angina, or myocardial infarction within the previous 6 months.
  9. Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular (e.g. arrhythmias, ischemic heart disease, tachycardia), cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric (e.g. depression, disorientation, euphoric mood and dissociation), dermatological or hematological disease or condition unless determined as not clinically significant.
  10. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or are currently pregnant or lactating.
  11. Anticipated change in chemotherapy or radiotherapy treatment plan during the 43-day course of the acute study.
  12. Known history of substance abuse.
  13. Inability to speak or read English.
  14. Inability to provide informed consent.

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Blood Markers of Early Pancreas Cancer

Summary: Identifying biomarkers of early pancreatic ductal adenocarcinoma (PDAC) could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.
  The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens.

Detailed description: Patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) have only an 8% chance of surviving 5 years after diagnosis. Most PDAC is advanced and not amenable to curative therapies at the time of diagnosis, owing to lack of symptoms in early disease, nonspecific symptoms when they do develop resulting in a delay in diagnosis. Identifying biomarkers of early PDAC could facilitate screening for individuals at higher than average risk and expedite the diagnosis in individuals with symptoms and substantially improve an individual's chance of surviving the disease.
  The investigators propose a longitudinal study of subjects at higher than average risk of PDAC in order to generate clinical data and bank serial blood specimens. Subjects will include individuals with family history of pancreas cancer, individuals with cystic pancreas lesions or chronic pancreatitis, and individuals with new-onset diabetes. Identifying specific biomarkers - blood markers and/or a clinical "prodrome" - in participants who go on to develop PDAC could improve the diagnostic approach outcomes for patients diagnosed with PDAC.

Eligibility: Inclusion Criteria:
  General inclusion criteria:
  1. Age ≥19
  2. Able to provide written, informed consent
  Exclusion Criteria:
  General exclusion criteria:
  1. Personal history of PDAC
  2. Currently receiving treatment for a cancer diagnosis (excluding long-term hormonal therapy)
  3. Pre-diabetes on metformin for ≥ 3 years

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Prostate Cancer Monitoring Using [18F]DCFPyL and Blood Based Biomarkers

Summary: Primary Objective:
  -  To determine whether changes in uptake of [18F]DCFPyL PET/CT scans at baseline and after 6 weeks of treatment for metastatic castrate resistant prostate cancer, correlates with radiographic progression free survival (rPFS) as defined by Prostate Cancer Working Group 3 (PCWG3) criteria.
  Secondary Objectives:
  -  To determine whether changes in uptake of [18F]DCFPyL PET/CT scans correlate with overall survival (OS)
  -  To determine whether baseline SUVmax correlate with rPFS
  -  To compare number of lesions detected with standard imaging at baseline and at the time of progression

Detailed description: Prostate cancer is the most common cancer and the third most common cause of cancer deaths in American men. The lethal form of the disease is metastatic castrate resistant prostate cancer (mCRPC). Serum prostate specific antigen (PSA) testing has been relied upon heavily as a marker of disease and is commonly used in the community to guide therapy.
  PyL, also known as [18F]DCFPyL, is a second-generation fluorinated prostate-specific membrane antigen (PSMA) targeted positron emission tomography (PET) imaging agent. In preliminary studies it demonstrates a higher detection of metastatic prostate lesions compared to standard imaging. However, the role of [18F] PyL in tumor response to therapy has not been evaluated, specifically the potential to serve as a predictive biomarker of response. Given the high cost of current therapeutic agents in mCRPC, there is a need for an early response biomarker to stratify which patients will benefit from therapy and which will not. This will also allow for earlier change in management of patients who will not response to these therapies, potentially improving patient outcomes.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed diagnosis of prostate cancer
  -  Age ≥ 18 years of age
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  -  Metastatic castrate resistant prostate cancer as defined by Prostate Cancer Working Group 3
  -  Eligible to receive systemic treatment (abiraterone, enzalutamide, docetaxel, cabazitaxel) for their disease
  -  Ability to understand and willingness to sign a written informed consent document
  -  Wiling to comply with clinical trial instructions and requirements
  Exclusion Criteria:
  -  History of another active malignancy within 3 years, other than basal cell and squamous cell carcinoma of the skin
  -  Presence of prostate brachytherapy implants
  -  Administration of another radioisotope within five physical half-lives of trial enrollment
  -  Radiation or chemotherapy within 2 weeks prior to trial enrollment
  -  Serum creatinine > 3 times the upper limit of normal
  -  Serum total bilirubin > 3 times the upper limit of normal
  -  Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >5 times the upper limit of normal
  -  Inadequate venous access

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy

Summary: This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT). Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.
  SECONDARY OBJECTIVES:
  I. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.
  II. Sequencing to identify frequently mutated genes such as TP53 and ATM.
  OUTLINE:
  Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

Eligibility: Inclusion Criteria:
  -  Volunteer patient
  -  Histologically confirmed prostate cancer
  -  Enrolled in Lu-PSMA-617 treatment trial (Institutional Review Board [IRB]# 17-000330)
  -  Based on positron emission tomography (PET)/computed tomography (CT) images: evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
  -  Platelets > 75,000/ul within 14 days prior to biopsy
  -  Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit of normal (ULN) within 14 days prior to biopsy
  -  Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)
  Exclusion Criteria:
  -  Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Atomoxetine for Freezing of Gait in Parkinson's Disease

Summary: Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.


Eligibility: Inclusion Criteria:
  1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
  2. A positive response to item 14 of the UPDRS, part 2.
  3. Age range 18-80
  4. Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
  5. Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
  6. Stable on PD medications for ≥ 3 months
  -
  Exclusion Criteria:
  1. Intolerance to drug class
  2. Mini-Mental Status Examination <26/30
  3. No observable episodes of freezing of gait despite common visual cues
  4. Not on stable PD medications for 3 months
  5. Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
  6. Current use of monoamine oxidase inhibitor (MAO-I)
  7. Hypersensitivity to drug class
  8. Narrow angle glaucoma
  9. Pheochromocytoma
  10. Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
  11. Patients with uncontrolled hypertension.
  12. Patients with a history of symptomatic tachyarrhythmias.
  13. Presence of uncontrolled depression and suicidal ideation.
  -

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Radiolabeled Gallium-68 (68Ga-PSMA) for PET/CT Imaging to Detect Prostate Cancer

Summary: The purpose of the study is to find out whether imaging of the prostate with a new molecule called 68Ga-PSMA can find prostate cancer. 68Ga-PSMA has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. This study is performed to test 68Ga-PSMA whether it can be used to find prostate cancers that would be considered in need for treatment.

Detailed description: In this study, two different imaging tests are being compared: a) 68Ga-PSMA Positron Emission Tomography (PET)/Computed Tomography (CT) and b) Magnetic Resonance Imaging (MRI) of the prostate gland. Participants already have received the MRI, and this test resulted either suspicious or definitive for prostate cancer. Both tests (MRI and 68Ga-PSMA PET/CT) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test.
  Another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. If imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future.
  To investigate these questions, participants are asked to undergo a 68Ga-PSMA PET/CT before a planned prostate biopsy procedure. After the biopsy procedure is performed, investigators will compare the imaging results from 68Ga-PSMA with those from the MRI and determine which test is more accurate.

Eligibility: Inclusion Criteria:
  -  Recent MRI of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the Radiologist as PI-RADS 3, 4 or 5 lesion)
  -  Treating physician has already indicated a need for a prostate biopsy procedure.
  -  Known Gleason 3+3 or 3+4 prostate cancer, OR rising PSA and single or multiple negative prior biopsies.
  Exclusion Criteria:
  -  Prostate biopsy within 12 weeks before enrollment
  -  Acute prostatitis within the last 6 months
  -  Current non-urologic bacterial infection requiring active treatment with antibiotics
  -  Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
  -  Body weight greater than 350 lbs (158 Kg)
  -  Inability or unwillingness to receive a prostate biopsy procedure
  -  Unable to lie flat, still, or tolerate a PET/CT scan
  -  Unable to provide own consent
  -  Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).

Relevance to patient case: not relevant
Patient case: 50-year-old male with prostate cancer; genetic feature: ATM deletion

Clinical trial: Comparison to Psychological, Medical and Emotional Influencing Communication and Achievement Factors to Oncogenetics Tests

Summary: The purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Detailed description: The risk associated with a genetic predisposition is among the various forms of risk, the strongest identifiable risk . It enables to offer people at risk an appropriate medical care (screening, prevention ) the clinical benefit is validated today. The person with whom a predisposing mutation has been identified must communicated its related information on the risk of cancer and the ability to perform genetic analysis. It appears that this dissemination of information is not always optimal, as shown in figures from the National Cancer Institute joined the project; the purpose of the study was to analyze the psychological and emotional determinants of domestic dissemination of information about genetic risk of cancer and to compare the level of diffusion syndromes in breast/ ovarian cancer ( BRCA1 / BRCA2) and colon/endometrial ( HNPCC )

Eligibility: Inclusion Criteria:
  -  Patient having a deleterious genetic mutation on genes BRCA1 and/or BRCA2 and or on genes MMR
  -  The patient being of the family (who carried out a full analysis of BRCA1/BRCA2 and/or those MMR )
  Exclusion Criteria:
  -  Patient not carrying a deleterious genetic mutation on the BRCA1/2 genes and/or those of the MMR system,
  -  Patient under guardianship, curator or unable to give his non-opposition,
  -  Adult patients protected by law.

Relevance to patient case: not relevant