araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Early Detection of Prostate Cancer by FACS

Summary: Early detection of prostrate cancer and development of metastases. The research will attempt to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the CellScan instrument. The test is based on measurement of cellular changes in response to the specific prostate antigen, PSA.


Eligibility: Inclusion Criteria:
  Experimental group : Males between the ages of 60-90 years, with medical diagnosis of prostate cancer according to both clinical and hematological examinations, before receiving any medical treatment.
  Control Group 1: Males between the ages of 60-90 years, with diagnosed benign prostate hyperplasia -BPH.
  Control Group 2: Males between the ages of 60-90 years, medically diagnosed as healthy.
  Control Group 3: Males between the ages of 60-90 years, medically diagnosed with another form of cancer, not prostate.
  Exclusion Criteria:
  Experimental group: Other known cancer or systemic infection. Control Group 1: Other known cancer or systemic infection. Control Group 2:Past hematological disorders nor cancer growth history. other known systemic infection, nor urinary tract infection. Patients hospitalized for orthopedic injuries of any type who are otherwise free of urinary tract infections.
  Control Group 3:Other known systemic infection, nor urinary tract infection.

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

Summary: This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.

Detailed description: Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
  -  Disease progression during antiandrogen therapy, having surgical or medical castration status.
  -  Karnofsky Performance Status 50-100
  -  Normal cardiac function
  -  Life expectancy at least 24 weeks.
  -  Laboratory criteria for eligibility will include
  -  A neutrophil count of at least 1500 per cubic millimeter
  -  A hemoglobin level of at least 9 gm%
  -  A platelet count of at least 1000,000 per cubic millimeter.
  -  A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution.
  -  Serum creatinine levels not more than 1.5 times the upper limit of the normal range
  -  Written informed consent
  Exclusion Criteria:
  -  Prior treatment with cytotoxic agents or radioisotopes
  -  Estrogen use for at least three months
  -  History of another cancer within the preceding five years (except basal or squamous-cell skin cancer)
  -  Brain or leptomeningeal metastases
  -  Symptomatic peripheral neuropathy of grade 2 or higher
  -  Uncontrolled intercurrent illness that would limit compliance with study requirements

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Germline Alterations of Tumor Susceptibility Genes in New York Cancer Patients

Summary: The basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. This is an exploratory study designed to generate hypotheses for further research.

Detailed description: To establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. To date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. We propose to utilize an anonymized design to obtain DNA from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. These data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. Polymorphisms to be screened for include those involving the genes PTEN, APC, TGF βR-I, BLM, CHK2, a p85 phosphoprotein, ATM, ER, PR, MCP-1, MPIF, CCR2/5, CCR3, and SULT1A1. Cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. Genes with SNPs known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. Specifically, candidate genes will be selected from 1) cytokine signaling, 2) DNA repair, and 3) apoptosis regulatory pathways.

Eligibility: Inclusion Criteria:
  -  Patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at MSKCC.
  -  All patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites.
  -  Patients of Ashkenazi Jewish ancestry with a histologic diagnosis of cancer of any type.
  -  Samples ascertained as part of protocol 98-024A(1) are also eligible for ascertainment in this study.
  Exclusion Criteria:
  -  MSKCC patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the AMDeC sponsored component of the study.

Relevance to patient case: definitely relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)

Summary: Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.


Eligibility: Inclusion Criteria:
  -  Men aged 40 - 80 years old
  -  Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA > 10. Pathology will be confirmed by at least two reviews
  -  Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation
  -  Ability to undergo serial TRUS procedures
  -  Ability to give informed consent
  Exclusion Criteria:
  -  Subject has known hypersensitivity to octafluoropropane.
  -  Evidence of distant metastatic disease on staging evaluation
  -  Previous treatment for prostate cancer, including any form of androgen ablation
  -  Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous
  -  Expected life expectancy less than 10 years
  -  Baseline testosterone < 200 ng/dL
  -  Subject with cardiac shunts and elevated pulmonary hypertension
  -  Subject has worsening or clinically unstable congestive heart failure.
  -  Subject has acute myocardial infarction or acute coronary syndrome.
  -  Subject has ventricular arrhythmias or is high risk for arrhythmias.
  -  Subject has respiratory failure, severe emphysema or pulmonary emboli.
  -  Subject has a history of cardiac shunt or pulmonary hypertension.

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Exercise for Physical Health in Men With Prostate Cancer

Summary: The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

Detailed description: Prostate cancer survivors with advanced disease are commonly treated with androgen deprivation therapy (ADT) to reduce testosterone. Serious side effects of ADT are rapid bone and muscle loss that can lead to osteoporosis and declines in neuromuscular function (strength, power, gait and balance) which increases the risk of fracture and falls (a risk factor for fracture) and impairs physical function. Men on ADT are 1.4 times more likely to fracture compared with their cancer-free peers and those who fracture have a poorer prognosis than those who do not. Self-report physical function is also lower among men on ADT. Exercise can prevent bone loss, neuromuscular declines and falls in several populations. However, the ability of exercise to prevent bone loss from ADT has not been tested, while data on exercise and neuromuscular function (strength only) in this population are limited to one published trial. The long-term goal of our research is to improve musculoskeletal health and function in cancer survivors. Critical first steps to meet this goal are to determine whether our previously tested program of impact and resistance exercise, shown to improve bone health and neuromuscular function in women, can prevent bone loss and neuromuscular declines in prostate cancer survivors on ADT. Based on our previous research, we have developed the Prevent Osteoporosis With Impact + Resistance (POWIR) program to be adapted to clinical populations at risk for bone loss and declines in neuromuscular function. Potentially, POWIR could mitigate bone and muscle losses from ADT, and thereby lower fracture risk and improve quality of life.

Eligibility: Inclusion Criteria:
  -  histologically confirmed prostate cancer
  -  presently receiving or planning to begin androgen deprivation therapy for prostate cancer
  Exclusion Criteria:
  -  Presence of bone metastases in the proximal femur and lumbar spine
  -  Clinically defined osteoporosis
  -  Current or previous use of medications known to affect bone metabolism
  -  Current regular participation (>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training
  -  A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not

Summary: A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the general population will be followed- up for two outcomes; CHD including acute myocardial infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD and HF associated with the use of bicalutamide compared to non-use will be estimated.


Eligibility: Inclusion Criteria:
  -  At least two years enrollment with the general practitioner
  Exclusion Criteria:
  -  Patients with cancer before start date of the study

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

Summary: In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed description: To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as
  -  Real-time RT-PCR
  -  Radioligand receptor binding
  -  Western blot
  -  Immunohistochemistry

Eligibility: Inclusion Criteria:
  -  50 yrs or greater
  -  International prostatic symptom score >= 8
  -  Maximal flow rate < 15mL/sec
  -  baseline PSA 2.5-10 ng/mL
  -  Pathologically proven BPH
  -  No medication history for BPH
  -  Able to give fully informed consent
  Exclusion Criteria:
  -  Previous use of alpha-blocker, 5-alpha reductase inhibitor
  -  Previous surgery for BPH
  -  Urologic cancer history
  -  Urethral stricture
  -  baseline PSA > 10ng/mL
  -  BP < 90/70 mmHg
  -  Orthotopic hypotension with syncope
  -  Serum Cr > 2.0 mg/dl, alanine aminotransferase > 1.5 times of normal limit
  -  Bacterial prostatitis within 1 year
  -  Urinary tract infection(UTI) more than 2 times within 1 year
  -  Active UTI or prostate biopsy within 1 month
  -  Unable to void
  -  Ped use because of incontinence
  -  Hypersensitivity to alpha-blocker that include quinazoline
  -  Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
  -  Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
  -  Psychiatric problem
  -  Alcohol abuse or other drug abuse history
  -  Severe comorbidities unable to perform long-term trial
  -  seems not to be appropriate to this study because of any other reasons

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Summary: Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.
  Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.


Eligibility: Inclusion Criteria:
  -  Hystological diagnosis of breast cancer
  -  Availability of tumor tissue
  -  Availability to assess the response to Trastuzumab according to RECIST criteria
  -  Availability of clinical data
  Exclusion Criteria:
  -  Unavailability of tumor tissue
  -  Impossibility to assess the response to Trastuzumab according to RECIST criteria

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom

Summary: RATIONALE: Studying samples of blood 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 study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with breast cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of breast cancer cases.
  -  To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer by comparing the frequency of alterations in breast cancer patients with the corresponding frequency in controls.
  -  To define the proportion of breast cancer incidence attributable to mutations in such genes.
  -  To examine the interactions between genetic and nongenetic risk factors.
  -  To evaluate the relationship between pathological and clinical characteristics of breast cancers and germline genotype.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire that covers standard known breast cancer risk factors including reproductive history, oral contraceptive use, hormone replacement therapy use, family history, and alcohol consumption. The questionnaire will also request identifying information on the patient's first-degree relatives.
  Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population-based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the breast cancer patients recruited for this study, patients with malignant melanoma and lymphoma, colorectal, ovarian, prostate, colorectal, bladder, kidney, pancreatic, and esophageal cancer, and brain tumors are recruited for the following related clinical trials: MREC-SEARCH-COLORECTAL, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer within the past 5 years
  -  Identified through the East Anglian Cancer Registry in the East Anglia region of the United Kingdom
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

Summary: RATIONALE: Studying samples of blood 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 study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with ovarian cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of ovarian cases.
  -  To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).
  -  To determine the risk associated with predisposing mutations by examining the cancer risks in relatives of patients who are shown to be carriers.
  -  To examine the effect of nongenetic risk factors in mutation carriers.
  -  To determine the pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.
  -  To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
  OUTLINE: This is a multicenter study.
  Patients complete an epidemiological questionnaire. The questionnaire will request identifying information on the patient's first-degree relatives.
  Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
  In addition to the ovarian cancer patients recruited for this study, patients with breast, endometrial, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of ovarian cancer within the past 5 years
  -  Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  Oxford
  -  Trent
  -  West Midlands
  PATIENT CHARACTERISTICS:
  -  Identified by the patient's general practitioner as fit to contact for this study
  -  No serious mental illness or retardation
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant