araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: BN83495 in Prostate Cancer

Summary: The purpose of the study is to evaluate the pharmacodynamic profile and safety of BN83495 in patients with prostate cancer with disease progression while on androgen ablative therapy

Detailed description: Evaluate the PD profile of BN83495 after 28 days of daily oral administration in patients with locally advanced or metastatic prostate cancer on androgen ablative therapy and with rising prostatic specific antigen

Eligibility: Inclusion Criteria:
  -  Confirmed and locally advanced or metastatic prostate cancer with rising prostate-specific antigen (PSA), while on androgen ablative therapy.
  -  Over age 18.
  -  Demonstrated PSA "biochemical failure".
  -  Adequate bone marrow and hepatic function
  Exclusion Criteria:
  -  Luteinizing Hormone-Releasing Hormone analogue treatment and treated with more than one additional second line of endocrine therapy
  -  Prior treatment with ketoconazole
  -  Prior chemotherapy for hormone refractory prostate cancer
  -  Pre-existing cardiac failure and/or clinically significant abnormal ECG or Echo

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations

Summary: The purpose of this study is to investigate the effect and the side effect profile of irinotecan and panitumumab administered every 3 weeks as 3rd line treatment for patients with metastatic colorectal cancer without KRAS mutations.

Detailed description: Colorectal cancer is one of the most frequent types of cancer in Denmark with approximately 3,400 diagnosed patients per year. The prognosis for these patients is still very poor and more than half of them will develop metastatic disease and thus be candidates for chemotherapy.
  In Denmark 5-FU and Oxaliplatin or Irinotecan has been used for several years either as combination or mono therapy. In recent years biological antibodies targeted against EGFR have been added to this treatment. A newly developed antibody is Panitumumab, which enables treatment every 3 weeks instead of weekly administration.
  The effect of EGFR activation is mediated through intracellular pathways involving the KRAS protein. It has been proven that a mutation of KRAS causes the KRAS protein to be constantly activated, and patients with these mutations do not benefit from antibodies against EGFR. Approximately 40% of the patients present these mutations.

Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum with metastatic spread.
  -  No mutations in the KRAS gene.
  -  Resistance to 5-FU, oxaliplatin and irinotecan.
  -  Age ≥18 years.
  -  PS 0-2.
  -  Measurable disease according to RECIST criteria.
  -  Haematology: Neutrophilocytes ≥1.5 x 109/l, leukocytes ≥3.0 x 109/l, thrombocytes ≥100 and bilirubinaemia ≤3 x upper normal value. Samples no more than 4 weeks old.
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Acceptance that blod and tissue samples are kept for subsequent investigation of biomarkers.
  -  Oral and written informed consent.
  Exclusion Criteria:
  -  Other malignant disease within the past 5 years, excl. non-melanoma skin cancer and carcinoma in situ cervicis uteri.
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks.
  -  Verified or clinically suspected CNS metastasis.
  -  Other experimental treatment.
  -  Serious medical disease according to investigator's judgement.
  -  Pregnant or breastfeeding women.
  -  Hypersensitivity to the active substance or to one or more of the auxiliary substances.
  -  Patients with interstitial pneumonitis or pulmonary fibrosis.

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Health-Related Quality of Life in Gay Men With Localized Prostate Cancer

Summary: RATIONALE: Gathering information about prostate cancer, treatment, and quality of life from gay men with prostate cancer may help doctors plan the best treatment.
  PURPOSE: This clinical trial is collecting information about health-related quality of life from gay men with localized prostate cancer.

Detailed description: OBJECTIVES:
  -  To enroll 200 gay men with localized prostate cancer in a cross-sectional study of prostate cancer outcomes.
  -  To complete an R01 application using pilot data collected from these patients.
  -  To complete manuscripts describing the factors that influence quality of life and treatment satisfaction in these patients.
  OUTLINE: Patients complete a web-based survey about their disease (biopsy Gleason score, PSA at diagnosis, and T-stage), treatment (treatment type, time since treatment, and use of healthcare services [e.g., oral medications for erectile dysfunction]), symptom distress, and psychosocial factors (ethnicity, health literacy, level of social support, communication with provider, relationship status, and communication with partner) that affect their health-related quality of life. The data will be used to provide the information necessary to tailor an existing prostate cancer survivorship intervention to address the specific needs of gay men with prostate cancer.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of localized prostate cancer
  -  No advanced disease
  -  Self-identified as gay
  PATIENT CHARACTERISTICS:
  -  Able to complete an online questionnaire
  -  Able to speak and understand English
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

Summary: The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.
  Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.

Detailed description: Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.
  Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.

Eligibility: Inclusion Criteria:
  -  patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
  -  patients who have not received any preoperative treatment for their diagnosis of prostate cancer
  Exclusion Criteria:
  -  patients with implants that are electronically, magnetically, or mechanically active
  -  patients with intracranial aneurysm clips
  -  patients who have undergone cosmetic eyelid surgery
  -  patients with history of pheochromocytoma, insulinoma and acute glaucoma
  -  patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Summary: The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.
  Hypothesis:


Eligibility: Inclusion Criteria:
  -  men aged 50 or older
  -  diagnosed with adenocarcinoma prostate cancer
  -  will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months
  Exclusion Criteria:
  -  severe cardiac disease (New York Heart Association class III or greater)
  -  angina
  -  severe osteoporosis
  -  uncontrolled hypertension
  -  orthostastic blood pressure drop > 20mm Hg
  -  moderate to severe aortic stenosis
  -  acute illness or fever
  -  uncontrolled atrial or ventricular dysrhythmias
  -  uncontrolled sinus tachycardia (> 120 beats per minute)
  -  uncontrolled congestive heart failure
  -  third-degree atrio-ventricular heart block
  -  active pericarditis or myocarditis
  -  recent embolism, thrombophlebitis
  -  deep vein thrombosis, resting ST displacement
  -  uncontrolled diabetes
  -  uncontrolled pain
  -  cognitive impairment
  -  history of falls due to balance impairment or lost of consciousness
  -  severe neuromusculoskeletal conditions that limit their ability to perform walking exercise

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Aberrant Gene Expression Prostate Carcinoma

Summary: The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

Detailed description: The goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. The approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. Application of the latter technique to colon cancer in the American population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. Presently the studies in the field of prostate are under-represented. The collection of tissue samples from patients diagnosed with prostate cancer. Patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. Samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. These samples will be obtained shortly following the biopsy out to 6 months after the biopsy.

Eligibility: Inclusion Criteria:
  -  Diagnosed prostate cancer undergoing prostatectomy
  -  Suspicion of prostate cancer undergoing biopsy - negative biopsy
  -  Health volunteer (control group) - blood sample for PSA
  Exclusion Criteria:
  -  Patients not fitting the inclusion criteria

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer

Summary: RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known which vitamin E regimen is more effective in preventing prostate cancer.
  PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how well they work in preventing cancer in patients at risk of prostate cancer or who have prostate cancer.

Detailed description: OBJECTIVES:
  -  Determine the effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E_2 by comparing the blood and urine samples collected before and after the supplementation in patients with prostate cancer.
  -  Test the hypothesis that the supplementation reduced oxidative and nitrosative stress by measuring plasma levels of F_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).
  -  Determine the levels of α-, γ-, and δ-tocopherols in prostate tissues and analyze immunohistochemically (IHC) for cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels in prostate cancer/tissue slides.
  OUTLINE: Patients are randomized into 1 of 3 arms.
  -  Arm I: Patients receive no supplementation.
  -  Arm II: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
  -  Arm III: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.
  Blood, urine, and tissue samples are collected periodically and analyzed for oxidative/nitrosative stress and other markers (i.e., F2-isoprostane, 8-OHdG, 3-nitrotyrosine, prostaglandin E2, C-reactive protein, and PSA), biomarkers in prostate tumors and nontumorous tissues (i.e., 8-OHdG, 3-nitrotyrosine, and cyclooxygenase-2) by IHC, and pharmacokinetics by high-performance liquid chromatography.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Abnormal digital rectal examination or abnormal prostate specific antigen (> 4.0 ng/mL)
  -  Obstructing prostate
  -  Biopsy-proven prostate cancer
  -  Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or prostatectomy)
  PATIENT CHARACTERISTICS:
  -  No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart failure, or history of renal insufficiency
  -  No personal or family history of a bleeding disorder
  -  No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic fibrosis)
  PRIOR CONCURRENT THERAPY:
  -  More than 2 weeks since prior NSAIDs or corticosteroids
  -  No concurrent supplementation of vitamin E (a multivitamin containing ≤ 60 IU of vitamin E is allowed)
  -  No concurrent colestipol or orlistat
  -  No concurrent warfarin or dicumarol

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: DNA Changes in Patients With Prostate Cancer

Summary: RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.

Detailed description: OBJECTIVES:
  -  Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
  -  Determine the age of onset of prostate cancer in affected probands and affected siblings.
  -  Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
  -  Determine the odds ratio of developing prostate cancer in the presence of SNPs.
  -  Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).
  OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.
  Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.
  PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Patient or sibling diagnosed with prostate cancer
  -  Cancer-free participant (healthy control)
  -  Whole blood sample available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is looking at tumor tissue samples from patients with early-stage breast cancer.

Detailed description: OBJECTIVES:
  -  To characterize differences in tumor morphology and molecular features that exist in good- and poor-prognosis breast cancer as determined by Oncotype Dx assay (a reverse transcriptase-PCR-based assay).
  -  To develop a computer-aided design (CAD)-based system of analysis of digitized histological images that would perform as well as Oncotype Dx assay in stratifying estrogen receptor-positive (ER+) breast cancer into prognostic categories.
  -  To identify new therapeutic targets in the PI3-kinase signaling pathway for a subset of poor-prognosis ER+ breast cancers.
  OUTLINE: Patients who had Oncotype Dx assay (a reverse transcriptase-PCR-based assay) performed for their breast cancer are identified by review of medical records. Diagnostic H&E stained tumor tissue samples are reviewed by a pathologist. Relevant pathologic features of the tumor (size, stage, grade, estrogen receptor, progesterone receptor, and HER2 staining) and linked Oncotype Dx score are recorded.
  The H&E stained tumor tissue samples are scanned to create high-resolution digital images. The images from each tissue sample are subjected to image analysis algorithms to identify sets of image features that most clearly separate tumors with low recurrence scores from those with high recurrence scores.
  Unstained paraffin sections from each tumor tissue sample, when available, are processed using IHC to analyze PI3-kinase signaling pathway (PTEN expression). Staining for other components of the PI3-kinase signaling pathway, phospo-AKT, and other proteins of interest is also performed. DNA is extracted from the samples and subjected to pyrosequencing analysis on exons 9 and 20 of PI3KCA. Sequencing of other relevant potential oncogenes, such as AKT, is also performed. Statistical analysis is performed to look for a correlation between Oncotype Dx scores and the presence of PI3KCA mutations and/or loss of PTEN expression.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of early-stage breast cancer for which an Oncotype Dx assay has been performed
  -  Must have diagnostic H&E stained tumor tissue samples available
  -  Hormone receptor status:
  -  Estrogen receptor-positive tumor
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Collection of Blood From Patients With Prostate Cancer

Summary: Background:
  -  It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.
  -  Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.
  -  Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.
  Objectives:
  -To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.
  Eligibility:
  -All patients participating in NCI prostate cancer protocols.
  Design:
  -  Patients with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.
  -  Blood samples are collected at the initial visit or at follow-up visits.
  -  DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.
  -  Gene variations are correlated with prostate cancer prognosis and prognostic indicators.

Detailed description: Objectives:
  To obtain blood samples from patients with prostate cancer for genotyping analyses.
  Eligibility:
  All patients seen in the NCI prostate cancer clinic are eligible.
  Design:
  Patients with a prior diagnosis of prostate cancer will be evaluated in the GMB Clinic, NCI. Blood samples may be collected at the initial visit or at follow-up visits. Genomic DNA and white blood cells will each be extracted from these samples to be utilized for genotyping and establishment of individual cell lines. Genetic variance will be correlated with prostate cancer prognosis (i.e. time from diagnosis to death) and prognostic indicators (i.e. histological tumor grade). Healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.

Eligibility: -  INCLUSION CRITERIA:
  Patients 18 years of age and older are eligible.
  Patients with a diagnosis of prostate cancer are eligible.
  EXCLUSION CRITERIA:
  Children are not eligible.

Relevance to patient case: not relevant