araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Solid Malignancies

Summary: To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Detailed description: Primary Objective:
  -  Determine response rate (RR; complete and partial response [CR, PR]) and duration after therapy with Aroplatin™ in patients with advanced solid malignancies.
  Secondary Objective:
  -  Determine the safety and tolerability of Aroplatin

Eligibility: Inclusion Criteria:
  -  Advanced solid malignancies;
  -  Amenable to therapy with DACH platinum agents;
  -  Measurable disease (RECIST criteria);
  -  ECOG performance score of 0-2;
  -  Adequate hematopoietic, liver and renal function;
  -  Adequate cardiac function (maximum of class II, NYHA);
  -  Women of childbearing potential must have a negative urine or serum pregnancy test;
  -  Signed written informed consent;
  -  Subjects must be willing to be followed during the course of treatment/observation and follow-up.
  Exclusion Criteria:
  -  No other active malignancies;
  -  No prior therapy with oxaliplatin;
  -  No known brain metastases;
  -  Active, uncontrolled infection or other serious medical illnesses;
  -  Not using or have used any investigational therapy during four weeks before start of protocol treatment.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Study Evaluating MAC-321 in Colorectal Cancer

Summary: Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.


Eligibility: Inclusion Criteria:
  -  Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection.
  -  Prior treatment with at least 1 conventional approved therapeutic regimen.
  -  Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible
  Exclusion Criteria:
  -  Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin)
  -  Prior radiotherapy to >25% of bone marrow
  -  Prior exposure to MAC-321

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Study Evaluating EKB-569 in Advanced Colorectal Cancer

Summary: This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced colorectal cancer. Patients must have been previously treated with a fluoropyrimidine (5-FU or capecitabine) and either oxaliplatin or irinotecan (given concurrently or as separate regimens).
  The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced colorectal cancer.
  Secondary objectives include:
  -  To further evaluate the safety of EKB-569
  -  To explore additional clinical activity parameters
  -  To explore subject survival
  -  To evaluate the pharmacokinetics of EKB-569
  -  To assess subject reported outcomes
  EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.


Eligibility: Inclusion Criteria:
  -  Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
  -  Previous histologic diagnosis of adenocarcinoma of the colon or rectum
  -  EGFR expression by immunohistochemical analysis (must be > or = 20% positive tumor cells in prior tumor biopsy specimens)
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas).
  -  Prior epidermal growth factor receptor-targeting therapy
  -  Known central nervous system (CNS) metastases

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP)

Summary: A study to evaluate rofecoxib in the treatment of rectal, colon, or duodenal adenomas in patients with Familial Adenomatous Polyposis.


Eligibility: Inclusion Criteria:
  -  Males or females at least 18 years of age with familial adenomatous polyposis.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Screening for Colorectal Neoplasm in First Degree Relatives of the Affected

Summary: To determine the prevalence of colorectal neoplasms in first degree relatives of those affected with sporadic colorectal cancer using colonoscopy as a screening tool. The prevalence will be compared to that of a defined matched cohort.

Detailed description: Colorectal cancer is a second commonest tumor in Hong Kong and the second commonest cause of cancer related death. About 1 in 23 males will develop colorectal cancer in his life time. The disease tends to cluster in families. This may be a combination of factors including shared genes, shared environment or chance. Known familial syndromes occur in only about 5% of cases. The majority is not well understood and labelled sporadic colorectal cancer. The screening strategy in families of subjects with colorectal cancer has not been defined. Colonoscopy is among the most sensitive and specific screening tool for colorectal neoplasm. The current study determines the prevalence of adenomas among first degree relatives of patients diagnosed with colorectal cancer. To quantify risk in this cohort, a case control analysis is used. The prevalence of the cohort is compared to that of a control population. The control group consists of relatives of patients with normal colonoscopic findings during the same study period.

Eligibility: Inclusion Criteria:
  -  First degree relatives (age >40 and <70) of individuals affected with sporadic colorectal cancer (those not associated with inflammatory bowel disease, familial adenomatous polyposis or HNPCC syndrome).
  Exclusion Criteria:
  -  A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria [Table 5].
  -  Known Familial Adenomatous Polyposis (FAP) syndrome
  -  Patients and relatives with known inflammatory bowel disease
  -  Relatives that have received colonoscopy examinations in the past 5 years [details of colonoscopic examinations will be sought and information on colonic neoplasms recorded]. Those who have had barium enema examinations are eligible for trial inclusion as barium examinations often have low sensitivity and specificity for adenomas (around 70% respectively)
  -  Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients

Summary: The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Familial adenomatous polyposis
  -  18 years of age or older
  -  5 or more adenomas of colorectum or ileum
  Exclusion Criteria:
  -  Female patient of child bearing age not on effective birth control pills
  -  Pregnant women
  -  White blood cell (WBC) count less than 4000
  -  Platelets (Plts) less than 100,000
  -  Blood urea nitrogen (BUN) greater than 25
  -  Creatine greater than 1.5
  -  Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
  -  Malignancy
  -  Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
  -  Patient on warfarin or anti-platelet drugs

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
  Hypothesis:
  Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility: Inclusion Criteria:
  1. Male, age 40-80 years.
  2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
  3. Diagnosis of Dysthymic disorder with onset after age 40.
  4. PSA < 4.0.
  5. Normal digital exam of the prostate in the preceding 1 year.
  6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
  7. Able to give informed consent.
  Exclusion Criteria:
  1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
  2. Currently being treated with testosterone.
  3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
  4. Current suicidal risk.
  5. Current (past year) substance abuse or dependence.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: NBI With Magnification for Dysplasia Detection in Ulcerative Colitis

Summary: The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white light alone.

Detailed description: Colorectal cancer is the second commonest cause of cancer death. Patients with colitis have a substantially increased risk of death from colorectal cancer which increases with lenght of time the patient has had colitis. This can be as high as a 30% chance of colorectal cancer after 30 years of colitis. Colonoscopic surveillance of colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed.
  Precancerous lesions in colitis are difficult to see and endoscopist have used spraying dye on the lining of the bowel (chromoendoscopy) successfully to improve detection of abnormal areas: however this is time consuming and requires extra time and equipment and despite the benefits seen in multiple studies is not widely used in routine clinical practice in the UK.
  Narrow band imaging (NBI) is a technique that relies on light filters to improve contrast for the smallest blood vessels in the bowel lining which shows up precancerous areas as they have a richer vascular network. It is sometimes described as "digital chromoendoscopy" as the images produced are similar to chromoendoscopy, but it is much simpler and quicker to use. With magnification it allows assessment of the fine mucosal surface pattern (pit pattern) of lesion which allows and assessment of their likelihood of being precancerous. Autofluorescence endoscopy uses short wavelength light and light filters to produce a false colour image of the bowel lining where polyps stand out. These techniques have been used with some success in the oesophagus and stomach but little work is available for the colon.
  We aim to see if NBI with magnification is better that standard colonoscopy for detecting precancerous areas. This is likely as it produces images similar to chromoendoscopy which is already shown to help. If a potentially precancerous area is found we will use other types of endoscopy, particularly NBI autofluorescence to see if these techniques are helpful for discriminating between pre-cancerous and non pre-cancerous areas

Eligibility: Inclusion Criteria:
  -  petients with colitis who meet surveillance criteria
  -  patients over 18 years of age
  Exclusion Criteria:
  -  pregnant patients
  -  unable or unwilling to give informed consent
  -  patients with severe active colitis who would be unsafe to endoscope

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Patient Navigator Project

Summary: Patient Navigation is a Supportive Care Intervention that addresses barriers to quality standard care by providing individualized assistance to patients and families. The NCI is conducting several research programs to test the effectiveness of this approach. The expected outcomes of patient navigation through the cancer care system include:
  -  Timely, definitive diagnosis following an abnormal test
  -  Timely treatment following positive diagnosis
  -  Patient satisfaction with the diagnostic and care system experience

Detailed description: The goal of our local project is to provide Tampa Bay with a culturally appropriate Patient Navigator Program that will decrease delay in diagnosis and delivery of cancer care in an acceptable and cost-effective manner leading to lower cancer mortality among our underserved populations. We will partner with community health centers in the Tampa Bay area to provide an avenue for patients who have received an abnormal screening for breast and colorectal cancer to easier pilot the course of the healthcare system. The populations served by this program will include African-Americans, Hispanics and rural Whites who are medically underserved due to lack of insurance, documentation issues and a variety of other barriers to health care.
  The primary outcome to be tested with this program is the time it takes for patients with an abnormality to receive a definitive diagnosis. Secondary outcomes such as patient satisfaction and cost-effectiveness will also be measured. This program occurs in three phases. In Phase I, the aim is to work closely with our key community partners to conduct formative research for the development of an acceptable, appealing, and appropriate Patient Navigator Program. The aim for Phase II is to conduct a group randomized controlled trial by having participating clinics randomly assigned to an intervention or control clinic. The outcomes from this phase in the project will be assessed through chart reviews, patient satisfaction surveys and other survey methods. In Phase III a comprehensive evaluation on the program will be produced and disseminated nationally.

Eligibility: Inclusion Criteria:
  -  Receive health care at one of the enrolled clinics
  -  Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement).
  Exclusion Criteria:
  -  Persons with previous history of breast or colon cancer will be excluded from the study

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.

Summary: This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States (New York).
  The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular pattern, belong to the same spectrum of genetically determined melanocytic proliferations that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi, dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as UV-exposure.

Detailed description: The investigations to this study will verify whether small CMN, "early" AMN and dermal nevi, characterized by globular pattern differ in their genetic alterations compared to reticular typed nevi. It will be expected that globular typed nevi and eventually dermal nevi lack B-RAF mutations whereas reticular nevi show alterations in the B-RAF gene. Study location: Graz

Eligibility: Inclusion Criteria:
  -  Healthy individuals aged 9 to 80 years showing one or more dermoscopically benign nevi with either uniform globular-cobblestone pattern or reticular pattern or a combination of both types
  Exclusion Criteria:
  -  Children under the age of 9 years
  -  Pregnant woman
  -  Patients with atypical nevi (i.e., melanoma cannot be clinically ruled out)
  -  Patients with immunosuppression
  -  Patients with sun exposure 4 weeks before enrollment

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Bowel, Urinary and Sexual Function After Laparoscopic Colorectal Surgery

Summary: Research Populations: Male patients scheduled for laparoscopic colorectal surgery
  Study Method: Questionnaire and function tests
  Hypothesis: A laparoscopic nerve-sparing operation is not inferior to reported open surgery in preserving urinary and sexual function.

Detailed description: There have been some reports that laparoscopically assisted rectal resection is associated with a higher rate of male sexual dysfunction compared with the open approach. But these reports are studied retrospectively.
  We examine the frequency of bowel, urinary and sexual dysfunction prospectively in patients who received laparoscopic colorectal surgery.
  We examine before operation, 7 days after, 3 months after, 6 months after and 12 months after operation, by questionnaires (International Index of Erectile Function (IIEF) 、Short Form-8 (SF8)、International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)、International Prostate Symptom Score(IPSS)、Gastro-Intestinal Functional Outcome(GIFO)) and function tests (uroflowmetry and US).

Eligibility: Inclusion Criteria:
  -  Male
  -  Laparoscopic right colon resection/laparoscopic rectal surgery
  -  20-80 years old
  -  ECOG performance status (PS) 0-2
  Exclusion Criteria:
  -  Emergent operation
  -  Previous proctectomy
  -  Severe urinary dysfunction

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

Summary: The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed colorectal cancer
  -  Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
  -  Progression on or following treatment for metastatic colorectal cancer
  -  Progression within 12 months of adjuvant chemotherapy for colorectal cancer
  Exclusion Criteria:
  -  Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
  -  Previous adjuvant therapy with irinotecan within 12 months of randomization
  -  More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.

Relevance to patient case: not relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants

Summary: RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer.
  PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.

Detailed description: OBJECTIVES:
  -  Compare Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization by healthy participants.
  -  Determine the impact of GERA feedback and UC on psychological distress in these participants.
  -  Compare GERA feedback vs UC in terms of intention to have CRC screening, perceived CRC risk, CRC knowledge, salience and coherence of CRC screening, and support for CRC screening in these participants.
  -  Identify factors that moderate the impact of GERA feedback on CRC screening utilization.
  OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 screening arms.
  -  Arm I: Participants receive standard primary care.
  -  Arm II: Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
  All participants undergo a fecal occult blood test 3 weeks after the screening office visit.
  PROJECTED ACCRUAL: A total of 1,950 participants will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Healthy participants meeting the following criteria:
  -  No personal history of colorectal polyps or cancer or inflammatory bowel disease
  -  No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative
  -  Nonadherent with standard CRC screening recommendations at the time of their index office visit
  PATIENT CHARACTERISTICS:
  -  Able to communicate with ease in English
  PRIOR CONCURRENT THERAPY:
  -  More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)

Relevance to patient case: not relevant