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

Clinical trial: Long-Term Follow-Up in Patients With Prostate Cancer After Surgery

Summary: This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.

Detailed description: PRIMARY OBJECTIVES:
  I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.
  II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.
  III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.
  OUTLINE:
  Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Eligibility: Inclusion Criteria:
  -  Diagnosis of prostate cancer
  -  Treated with a definitive surgical procedure at City of Hope
  -  At least one year post surgical treatment for prostate cancer
  -  No history of recurrent, progressive, or metastatic disease
  -  Currently stable disease or no evidence of disease
  -  No prior treatment of prostate cancer with radiation or chemotherapy
  -  No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer
  -  Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician
  Exclusion Criteria:
  -  Current treatment with testosterone replacement or androgen deprivation therapy
  -  Treatment for another noncutaneous cancer within the past 2 years

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

Clinical trial: Study of Topical ABI-1968 in Subjects With Precancerous Anal Lesions Resulting From Human Papillomavirus (HPV) Infection

Summary: This study evaluates the use of ABI-1968, a topical cream, in the treatment of anal precancerous lesions in adults with and without human immunodeficiency virus (HIV) infection.


Eligibility: Inclusion Criteria:
  1. Female or male subjects, at least 27 years old.
  2. Confirmed diagnosis of intra-anal HSIL at least 3 months prior to screening and confirmed by histopathology (with p16 positive staining)
  3. Intra-anal HSIL are visible and evaluable by HRA at the time of screening, and no lesion(s) is suspicious for invasive cancer.
  4. For HIV-positive subjects, CD4 count must be at least 200/mm3 with undetectable (<50 copies/mL) viral load within the 3 months prior to enrollment. Subjects must be on a stable regimen of antiretroviral drugs for the 3 months prior to enrollment.
  Exclusion Criteria:
  1. Women who are pregnant, plan to become pregnant in the next 3 months, or lactating females.
  2. Received topical treatment or ablative procedures for aHSIL in the 6 months prior to enrolment.
  3. History of cancer, including anal cancer (with the exception of basal cell or squamous cell carcinoma of the skin), or currently undergoing treatment for any skin cancer.
  4. History of genital herpes with > 3 outbreaks per year.
  5. Plan to have excision or ablation of the lesion(s) within 3 months of enrolment.

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

Clinical trial: Biobank for African American Prostate Cancer Research in Florida

Summary: The purposes of this study are: a) to develop a statewide Biobank for prostate cancer among men of African Ancestry in Florida and; b) to examine whether smoking increases the aggressiveness of prostate cancer using several biological approaches.
  Investigators plan to contact African American prostate cancer patients regarding participation. This project has 3 main components. Eligible patients may choose to participate in any or all parts of the study: Questionnaires; Saliva Samples; Tumor Tissue.

Detailed description: This project will create the first state-wide data and biospecimen bank for men of African ancestry with prostate cancer. The sampling strategy and size of the study population ensure that the cohorts is representative, enhancing validity of studies based on this resource. In addition, there are no data on the role of smoking in African American prostate cancer. The approach to share the resource with Florida prostate cancer researchers is innovative and possible because the four annual prostate cancer symposiums organized by Moffitt has unified many Florida prostate cancer researchers who are now well connected and actively collaborating, as evidenced by publications and funded projects among participants.

Eligibility: Inclusion Criteria:
  -  The initial recruitment of cases will be done with 3 mailings: the first to introduce the study to the participant from Florida Cancer Data System (FCDS) of the Florida Department of Health and ask them to complete the eligibility form and contact information update form; a second mailing to those who are determined to be eligible for the study to obtain the Informed Consent Form and the Baseline survey; and a third mailing to those who completed the survey to obtain a saliva sample and medical release form for tissue.
  -  Histologically biopsy confirmed, primary prostate cancer, diagnosed between January 2013 and December 2015
  -  African American or Black; Hispanic Black; Afro-Caribbean
  -  Are at least 20 years old
  -  Are a resident of Florida
  -  Additional criteria may apply
  Exclusion Criteria:
  -  Does not meet Inclusion Criteria

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

Clinical trial: Unmet Supportive Care Needs in Bladder Cancer Patients Undergoing Radical Cystectomy

Summary: Nowadays, high-quality cancer care is more than just diagnosis and treatment of cancer. Healthcare must respond to the specific needs of the patients to provide patient-centered care. To date, research on the unmet supportive care needs in bladder cancer patients undergoing radical cystectomy is scarce. Because the needs of the patients may differ according to the phase in the illness trajectory, it is important that prospective research is carried out. Research in other cancer populations shows that unmet supportive care needs are negatively associated with health-related quality of life, psychological distress, physical activity and the health literacy of the patient. By incorporating the above factors into this study, we can not only map the unmet supportive care needs of the patient, but also explore possible associations between the variables. Since this is the first prospective study on supportive care needs in bladder cancer, this is a hypothesis-generating study.


Eligibility: Inclusion Criteria:
  -  age is 18 years or older
  -  Patients diagnosed with bladder cancer who will undergo radical cystectomy
  -  Patient has to be able to sign informed consent
  Exclusion Criteria:
  -  Metastatic cancer
  -  Presence of a second primary tumor with the exception of fully deleted prostate cancer, non-melanoma skin tumor or tumor diagnosed ≥ 5 years ago and under control

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

Clinical trial: Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Summary: This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.

Detailed description: There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients.
  Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion.
  So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion

Eligibility: Inclusion Criteria:
  1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
  2. Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;
  3. The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
  4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
  5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;
  6. Normal liver,kidney and bone marrow function；
  7. Subjects who understand and voluntarily signed a written informed consent form.
  Exclusion Criteria:
  1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis
  2. There is any contraindication to use Bortezomib
  3. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
  4. A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
  5. Pregnant or lactating women.
  6. History of radiation within 4 weeks prior to enrollment.

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

Clinical trial: Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Summary: Background:
  Prostate cancer is one of the most common cancers for men in the U.S. There are some new ways to take pictures of the cancer. There are also new ways to use image-guided biopsy and therapy. These could help manage prostate cancer. Researchers want to study how imaging can provide a profile of prostate cancer. They want to collect data to make diagnosis and treatments better.
  Objectives:
  To gather data about the radiological and clinical course of prostate cancer. To study imaging-based biomarkers of prostate cancer.
  Eligibility:
  Men ages 18 and older with diagnosed or suspected prostate cancer
  Design:
  Participants will give permission for researchers to use their medical history and records. Their data will be reviewed, collected, and analyzed. These include results of their tests and scans.
  Sponsoring Institution: National Cancer Institute

Detailed description: Background:
  -  Multiparametric MRI (mpMRI) has become an established method for localizing clinically significant prostate cancer, and identification of imaging-based prognostic markers represents an active research area.
  -  Multiple treatments are available for patients with localized prostate cancer, including radical prostatectomy, external beam radiotherapy, brachytherapy, and focal ablation; however, therapy-specific indication and imaging-based response biomarkers are poorly understood.
  -  As mpMRI is considered a standard of care , there is no patient consent for research related to imaging biomarkers and their correlation with other clinical and pathologic features.
  -  Translation of imaging, clinical, and pathological-based features into treatment decisions has yet to be fully characterized for development of a decision-support system.
  -  Therefore, the purpose of this protocol is to enable the collection of data to enable research in the development of computer aided diagnosis, decision support and deep learning/artificial intelligence research.
  Objective:
  - To evaluate radiological profiling of patients with prostate cancer in support of the Molecular Imaging Branch (MIB) for identification of imaging-based prognostic markers in prostate cancer.
  Eligibility:
  -  Patients with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
  -  Age greater than or equal to 18 years.
  Design:
  - Imaging evaluation and clinical profiling of patients with or suspected of prostate cancer obtained during visits to NCI and long-term follow up will be collected and analyzed.

Eligibility: -  INCLUSION CRITERIA:
  -  Patients with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
  -  Age greater than or equal to 18 years
  -  Ability of subject to understand and the willingness to sign a written informed consent document.
  -  Subject must be enrolled on an NIH screening, diagnostic or treatment protocol
  EXCLUSION CRITERIA:
  -none

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

Clinical trial: Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma

Summary: The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.

Detailed description: Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein.
  Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional

Eligibility: Inclusion Criteria:
  1. Be ≥18 years of age.
  2. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma.
  3. Have archival tumor tissue that can be provided for assessment of MTAP deletion status.
  4. Have given written informed consent to participate in this study.
  Exclusion Criteria:
  1. Have a primary CNS malignancy (eg, GBM).
  2. Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.

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

Clinical trial: Diet, Physical Activity and Related Candidate Biomarkers in Relation to Prostate Cancer Risk (BIOCaPPE)

Summary: The risk of prostate cancer is associated with lifestyle habits, such as diet and physical activity. Indeed, results of numerous studies suggest links between obesity, diabetes, inflammation and androgen and estrogen metabolism in the pathogenesis of prostate cancer.
  The goal of BIOCaPPE study (Biomarkers and Prostate Cancer/ Prevention and Environment) is to identify biomarkers of prostate cancer risk that are potentially modifiable by environmental exposures (e.g. diet and physical activity).
  A selection of few of the most promising biological markers will be evaluated in a cohort of more than 3000 men at high-risk of prostate cancer.
  Such biomarkers would provide a practical approach to identify men at high risk of prostate cancer who could benefit from interventions aiming at reducing their risk. The biomarkers would also be useful to monitor the efficacy of the interventions on patient's lifestyle.

Detailed description: The main objective of the proposed research project is to assess the association between five candidate biological markers potentially modifiable by environmental exposures (diet and physical activity) and the two-year risk of prostate cancer in a newly recruited cohort of men at high-risk of prostate cancer showing no evidence of cancer.
  Four hospitals in the province of Quebec (Canada) participate to the recruitment of 3,080 men at high-risk for prostate cancer, i.e. men who had a first negative prostate biopsy or whose Prostatic Specific Antigen (PSA) level is between 2.5 and 10 ng / ml without previous prostate biopsy.
  The candidate biomarkers that will be tested are:
  1. The ratio of ω-3/ ω-6 fatty acid content of red blood cell membranes,
  2. Oxidized low density lipoprotein cholesterol
  3. Adiponectin
  4. Insulin growth factor-1
  5. The ratio of dihydrotestosterone glucuronide derivatives over estradiol
  A biobank, composed of biological material (whole blood, plasma, serum, lymphocyte layer and excess tissue collected from prostate biopsy or prostate surgery) and clinical data is being created. Questionnaires are used to compile information on socio-demographic aspects, family and personal medical history, quality of life, lifestyle like food and sexual habits.

Eligibility: Inclusion Criteria:
  -  Group 1: serum-PSA level≥ 2.5 ng/L and a first negative prostate biopsy within 6 months
  -  Group 2: serum-PSA level between 2.5- 10 ng/ml and no prior prostate biopsy
  Exclusion Criteria:
  -  Prostate cancer
  -  Positive result for transurethral prostatic resection

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

Clinical trial: A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies

Summary: The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).
  The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).


Eligibility: Inclusion Criteria:
  -  Patients with relapsed or refractory AML. Relapsed AML is defined as relapse after achieving a response to initial therapy and refractory AML is defined as failure to achieve a response after one previous line of therapy. Response is defined as per IWG criteria (CR, CRi or CRp). Patients who are not candidates to receive or who decline standard of care therapy are also eligible.
  -  Patients with intermediate-1 or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a 5q-chromosomal deletion.
  -  Patients with relapsed/refractory CMML.
  -  Estimated glomerular filtration rate (eGFR) > 40 mL per 1.73 m*2
  -  Patients must have adequate coagulation (international normalized ratio [INR] ≤ 1.5; activated partial thromboplastin time [aPTT] ≤1.5 X the upper limit of normal [ULN]; patients on chronic anticoagulation therapy at investigator's discretion; patients on chronic use of direct-acting oral anticoagulants who have acceptable benefit-risk ratio at investigator's discretion)
  -  Adequate liver function (total bilirubin ≤1.5 X ULN (or ≤3 X ULN in patients with documented Gilbert's syndrome or for patients with hyperbilirubinemia considered due to myeloid disease), alanine aminotransferase [ALT] and aspartate aminotransferase [AST] ≤3 X ULN (or ≤5 X ULN for patients with liver involvement of their myeloid disease)
  Exclusion Criteria:
  -  Patients eligible for hematopoietic stem cell transplantation
  -  Clinical symptoms suggesting active central nervous system (CNS) leukemia or known CNS leukemia
  -  Human immunodeficiency virus (HIV) infection
  -  Chronic or active hepatitis B or C if not controlled by antiviral therapy
  -  History of organ allograft (allogeneic bone marrow or stem cell transplant) within 3 months prior to first dose of study drug
  -  Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted
  -  Left ventricular ejection fraction (LVEF) <40%

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

Clinical trial: Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution

Summary: Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques.
  Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.


Eligibility: Inclusion Criteria:
  -  Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016.
  -  Follow up > 6 years
  -  Negative pre surgical extension assessment
  -  Prognostic Grade Groups (OGG) III-IV-V
  -  Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL
  -  Metastasis positive imaging
  Exclusion Criteria:
  -  Neoadjuvant therapy
  -  Follow up < 6 years
  -  Prognostic Grade Groups (PGG) I-II
  -  Biochemical recurrence with metastasis negative imaging

Relevance to patient case: not relevant