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

Clinical trial: Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, 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 and the interactions between genes and the environment in patients with prostate cancer.

Detailed description: OBJECTIVES:
  -  To obtain epidemiological information and biological material on a population-based series of prostate cancer cases.
  -  To identify novel cancer susceptibility genes by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
  -  To estimate the age and sex-specific risks associated with variants in predisposition genes.
  -  To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.
  OUTLINE: This is a multicenter study.
  Patients complete a detailed epidemiological questionnaire, including information on education, occupation, smoking habits, alcohol consumption, height, weight, family history of cancer, and past medical history.
  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 prostate cancer patients recruited for this study, patients with breast, ovarian, endometrial, 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-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of prostate cancer within the past 5 years
  -  Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:
  -  East Anglia
  -  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
Patient case: 70-year-old male with prostate cancer; genetic feature: PTEN

Clinical trial: A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

Summary: to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Detailed description: Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Eligibility: Inclusion Criteria:
  -  patients diagnosed with clinically localized prostate cancer
  Exclusion Criteria:
  -  patients with another malignancies

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

Clinical trial: MRI in Assessing Hypoxia in Patients With Localized Prostate Cancer Undergoing Stereotactic Body Radiation Therapy

Summary: RATIONALE: Diagnostic procedures, such as MRI, may help measure oxygen levels in tumor cells. It may also help doctors predict a patient's response to treatment and help plan the best treatment.
  PURPOSE: This clinical trial is studying how well MRI works in assessing hypoxia in patients with localized prostate cancer undergoing stereotactic body radiation therapy.

Detailed description: OBJECTIVES:
  -  To characterize the status of global hypoxia within the prostate before stereotactic body radiotherapy (SBRT) as assessed by blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI.
  -  To characterize tumor vasculature and metabolism within the prostate before SBRT as assessed by dynamic contrast-enhanced MRI and magnetic resonance spectroscopic imaging, respectively.
  -  Correlate prostate and normal tissue hypoxia before SBRT with clinical outcomes (toxicity and biochemical [PSA] control) after SBRT.
  OUTLINE: Within 1-3 weeks before beginning stereotactic body radiotherapy, patients undergo T2-weighted anatomic MRI, magnetic resonance spectroscopic imaging, blood-oxygen-level-dependent and tissue-oxygen-level-dependent MRI, and dynamic contrast-enhanced MRI.

Eligibility: DISEASE CHARACTERISTICS:
  -  Biopsy proven adenocarcinoma of the prostate
  -  Localized disease
  -  Scheduled to undergo treatment with stereotactic body radiotherapy (SBRT) on a phase II clinical trial
  -  Has not yet started SBRT
  PATIENT CHARACTERISTICS:
  -  Serum creatinine ≤ 1.2 mg/dL
  -  No claustrophobia
  -  No other contraindication to MRI (e.g., implanted pacemaker device)
  -  No known allergy to MRI contrast
  PRIOR CONCURRENT THERAPY:
  -  No prior treatment for prostate cancer (e.g., hormonal therapy or chemotherapy)

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

Clinical trial: The Expression of PTEN Protein and mRNA in Malignant Cells of Chronic Myelomonocytic Leukemia

Summary: The purpose of this study is to evaluate the level of a specific protein (PTEN) in the cancer cells of chronic myelomonocytic leukemia (CMML) patients. This protein might be involved in the transformation from normal blood cells to leukemia cells. The PTEN protein has not been investigated in CMML specifically but it has been discovered in closely related cancers. If this study demonstrates an abnormality in this protein, future testing will be designed to evaluate the genetic abnormality that resulted in lack of the normal presence of this protein. The goal is that the results of this study will help to develop new drugs and strategies to treat the future patients with CMML by understanding the abnormality of the disease at the cellular and molecular levels. The results of this study can also be utilized by future studies to develop individualized treatment to patients who have abnormal levels of this protein.


Eligibility: Inclusion Criteria:
  -  Subject must be at least 18 years or older.
  -  Subject must sign informed consent.
  -  For study population only, the subject must have a CMML diagnosis based on the WHO 2009 criteria.
  -  For control population only, the subject must be deemed healthy with no hematologic disorders.

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

Clinical trial: Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment

Summary: RATIONALE: Gathering information about survivors of prostate cancer and their partners may help doctors learn more about the goals for sexual functioning after cancer treatment. PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer survivors and their partners after cancer treatment.

Detailed description: Detailed DescriptionOBJECTIVES:
  I. To collect data on the goals of sexual functioning among prostate cancer survivors and their partners following cancer treatment in order to identify specific components of interventions for future grant submissions on the psychosexual needs of prostate cancer survivors.
  OUTLINE:
  Patients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index.

Eligibility: Inclusion Criteria:
  -  Prostate cancer survivors who are: willing and able to provide informed consent; able to read, write, and speak English; married or are in married-like relationship; completed radiation or surgery for their prostate cancer 6 months to 5 years ago
  -  Partners of prostate cancer survivors must be: willing and able to provide informed consent; able to read, write, and speak English
  Exclusion Criteria:
  -  Prostate cancer survivors will be excluded if they have undergone androgen deprivation therapy within the past 6 months and if their partners refuse to participate

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

Clinical trial: Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

Summary: The purpose of this study is to try to understand the biology of development of breast, ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk for these diseases. The influence of environmental factors on cancer development in individuals and families will be studied. The efficacy of treatments for these diseases will be evaluated.

Detailed description: 1. To establish a demographic database to evaluate the efficacy of medical interventions in patients and relatives who carry BRCA1 and 2 mutations and to compare these outcomes to patients who do not carry a BRCA1 or 2 mutation.
  2. To obtain blood samples from patients who undergo genetic testing to a) evaluate the incidence of genetic modifier polymorphisms involved in the development of cancer in BRCA1 and 2 mutation carriers and to compare this incidence to non-BRCA 1 and 2 carriers. b) to understand the interaction of genetic modifiers and BRCA1 and 2 in the development of cancer. c) to determine the effect of environmental influences on the incidence of polymorphisms in genetic modifiers and on the penetrance of BRCA1 and 2 mutations by linking information from our demographic database to blood samples and
  3. To obtain tumor tissue from BRCA1 and 2 carriers to utilize for gene expression studies.
  4. To establish a cohort of sporadic breast cancer patients, or women with no family history of cancer in a first degree relative, to serve as a comparison group to women with strong family history of breast cancer.
  5. To establish a cohort of healthy volunteers without personal or family history of cancer to serve as a comparison group to women with sporadic and familial breast cancer.

Eligibility: Inclusion Criteria:
  I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.
  II. Women who are approaching surgery for resection of a pelvic mass, which is considered suspicious for neoplasia by radiologic or clinical criteria; such women may or may not also meet criteria for inclusion in group I.

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

Clinical trial: The Effectiveness of 18F-fluorocholine Positron Emission Tomography (PET) in Detecting, Staging and Following-up Prostate Cancer

Summary: Choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. Some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or metastatic prostate cancer has been recently reported in limited studies. This study will be conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.

Detailed description: Background:
  Prostate cancer is a leading cause of cancer death for male in Taiwan. Although 18F-FDG PET has been shown to be an effective tool in diagnosing many malignancies, previous studies have shown that 18F-FDG is not a suitable PET tracer for detecting prostate cancer. Choline is one of the components of phosphatidylcholine, an essential element of phospholipids in the cell membrane. Some malignant cells show their ability to actively incorporate choline to produce phosphocholine and phosphatidylcholine to facilitate tumor cell duplication. The efficacy of 18F-fluorocholine (18F-FCH) for localizing primary or metastatic prostate cancer has been recently reported in limited studies.
  Purpose:
  This study will be conducted to delineate the effectiveness of 18F-FCH PET in (1) differentiating benign prostate hypertrophy (BPH) from prostate cancer, (2) staging prostate cancer, (3) following-up patients with prostate cancer after initial curative therapy.
  Patients and Methods:
  This study will include
  1. Group 1: 50 patients with BPH
  2. Group 2: 50 patients with newly diagnosed prostate cancer and
  3. Group 3: 50 patients who have received curative treatment for prostate cancer and are suspicious of recurrence/metastases because of a persistent increase in their serum PSA.
  18F-FCH whole-body PET will be performed for each patient
  Expected Results:
  To evaluate the effectiveness of 18F-FCH in the diagnosis, staging and follow-up of prostate cancer.

Eligibility: Inclusion Criteria:
  Group 1: 50 patients with BPH
  1. Age above 35 years old
  2. Histologically confirmed BPH
  3. Informed consent signed
  Group 2: 50 patients with newly diagnosed prostate cancer and
  1. Age above 35 years old
  2. Histologically confirmed prostate cancer
  3. Informed consent signed
  Group 3: 50 patients who have
  1. Age above 35 years old
  2. Histologically confirmed prostate cancer and had received curative treatment for prostate cancer
  3. suspicious of recurrence/metastases because of a persistent increase in their serum PSA
  4. Informed consent signed
  Exclusion Criteria:
  -  Patients with other known malignancies will be excluded.

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

Clinical trial: Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

Summary: The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

Detailed description: Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume > 0.5cc; Gleason > 6) prostate carcinoma in the prostate.
  Objective 1
  To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating:
  1. focal areas of low signal intensity on T2-weighted images;
  2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
  3. the extent and degree of apparent diffusion coefficient reduction on DWI;
  4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology.
  Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.

Eligibility: Inclusion Criteria:
  -  Biopsy-proven diagnosis of adenocarcinoma of the prostate
  -  Subject will sign a consent form prior to study entry
  -  Radical prostatectomy and histopathological exam planned
  -  The time interval between last biopsy and the MR exam must be at least 4 weeks
  -  The time interval between MR exam and radical prostatectomy should not exceed 12 weeks
  Exclusion Criteria:
  -  Subjects who are unable to give valid informed consent
  -  Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
  -  Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
  -  Patients under hormone deprivation therapy.

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

Clinical trial: Prostate Cancer Antigen 3 (PCA-3) Gene Project

Summary: Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.
  Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene.
  The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.

Detailed description: Nowadays, prostate cancer screening is largely widespread although it is not recommended yet. This screening includes primarily digital rectal examination and PSA.
  The main drawback is the poor PSA specificity. Prostate cancer diagnosis is only histologic diagnosis (mainly by prostate biopsies). However, prostate needle biopsies have a poor rentability and are negative in 60 to 80%. Recently, a new specific genetic marker of prostate cancer has been discovered. It is PCA-3 gene. This gene encodes for RNAm noncoding. So, RNA expression must be assayed by RT-PCR. The main objective is to evaluate prospectively this new marker in patients treated for prostatic pathology (benign or malign) in the department.
  PCA-3 assay will be made from urine specimens collected by vesical catheterism just before surgery. Moreover, the investigators will analyse expression of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2). The main objective is to improve the prostate cancer diagnosis specificity. Gene expression will be assayed by RT-PCR.
  Prostatic cells in urine specimens will be confirmed by assay of PSA gene expression. Normalization of data will be performed using 3 housekeeping genes expression (ß-actin, K-a-1 tubulin and Glyceraldehyde-3-phosphate).
  The originality of this clinical study compared to previous reports, consists to two elements. Firstly, all patients included in our study will be operated for a prostate cancer or a BPH. So, the risk to ignore a prostate cancer will be low unlike prostate biopsies made for a prostate cancer screening. Secondly, PCA-3 assay will be coupled with others prostatic specific markers.

Eligibility: Inclusion Criteria:
  -  Patients operated for a prostate cancer or a benign prostatic hypertrophy
  -  Patients not in state of emergency
  Exclusion Criteria:
  -  Patients with an urinary infection proved bacteriologically
  -  Patients with a vesical malign disease
  -  Patients in state of emergency

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

Clinical trial: Epidemiologic and Genetic Study on Familial Prostate Cancer

Summary: The aims of the study are:
  -  to identify genetic and molecular factors (rare mutations, polymorphisms) involved in the natural history of prostate cancers and their response to treatment,
  -  to evaluate and deduce their medical applications for screening and therapeutic management of these tumors.

Detailed description: The impact of genetic factors on the natural history of prostate cancer (PC) is shown schematically at two levels:
  1. first, at the constitutional level with germline alterations. Family history is found in 20% of PC patients. Different clinical entities associated with different modes of inheritance, susceptibility mutations or polymorphisms, define different evolutionary patterns. Also, studies suggested that some genetic polymorphisms alter the response to some treatments (such as recurrence after prostatectomy or radiotherapy) or adverse effects of those above (such as toxicity of radiation therapy).
  2. secondly, PC is characterized by the accumulation of genetic alterations (somatic alterations or acquired mutations). These changes contribute in varying degrees to the aggressiveness of the disease (such as early metastatic potential) and treatment failure (such as resistance to radiation or hormone resistance).
  The purpose of this study is to establish a register, with a follow up of cohort type and a collection of biological samples:
  -  For men with known prostate cancer.
  -  For men with no prostate cancer after a screening procedure for this disease, so that their biological samples can be compared to those of men with prostate cancer.
  The registry data and collected biological samples are used to identify genetic and molecular factors involved in susceptibility, genesis and evolution of prostate cancers.

Eligibility: Inclusion Criteria:
  -  patient with a histological confirmed prostate cancer
  -  member of a hereditary prostate cancer family
  -  healthy control men without prostate cancer
  Exclusion Criteria:
  -  Absence of signed informed consent
  -  refusal to participate in the study

Relevance to patient case: not relevant