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

Clinical trial: Establishing Effective Screening Methods for Diagnosing Hereditary Nonpolypoisis Colorectal Cancer

Summary: Correct identification of Lynch syndrome at the time of colorectal cancer presentation is important. We aim to find best ways to screen patients with colorectal cancer in Korea.

Detailed description: Patients with newly diagnoised colorectal cancer will be eligible. They will undergo detailed history taking including family history, and molecular stuidies including microsatellite instability test and immunohistochemistry for DNA mismatch repair protein with pre-selection. Any abnormal finding in molecular stuides will be offered genetic testing (after testing methylation status for patients with abnormalities in MLH1).

Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  Exclusion Criteria:
  -  Histology showing other than adenocarcinoma

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

Clinical trial: Oslo Antioxidant Study

Summary: The primary objective of this study is to test whether increasing the total intake of antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative damage, and improves biomarkers for oxidative stress.
  The secondary objectives is to test whether this strategy improves other cardiovascular risk markers including platelet function, lipid levels, inflammation, and markers of endothelial damage.

Detailed description: In this study men smoking 5 or more cigarettes daily will be invited to participate. We will only include individuals with high cardiovascular risk (men rather than women, smokers rather than nonsmokers, middle-aged to elderly rather than young individuals), in order to recruit people with presumed high oxidative stress who might be most likely to show an effect and benefit from our intervention.
  at the time of inclusion, participants will be randomized to three groups; control group, kiwi group or phytochemical group. The kiwi group will consume three kiwis a day, whereas the phytochemical group will consume an array of antioxidant-rich food stuffs. The intervention period is eight weeks.
  Blood samples will be collected before and after the intervention period.

Eligibility: Inclusion Criteria:
  -  Men aged 45-75 years
  -  Daily smoker of a minimum of 5 cigarettes a day
  -  BMI <35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet)
  -  Stable weight range of 4 kg or less during the previous 12 weeks
  Exclusion Criteria:
  -  Any symptomatic CVD (myocardial infarction, angina pectoris, CABG, PCI, CHF, NYHA class III-IV)
  -  Diabetes type I or type II taking drugs for diabetes
  -  Following a vegetarian diet or near-vegetarian diet currently
  -  Allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes
  -  Clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations
  -  History of serious or unstable medical or psychiatric disorder
  -  Current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (NSAID), according to assessment of the primary clinical investigator. Any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. These are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. Paracetamol, however, can be taken as an alternative if required
  -  History of alcohol/or drug abuse
  -  Participation in a drug trial during the previous 30 days
  -  Use of drugs (Xenical, Reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program
  -  Use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2)
  -  Individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.

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

Clinical trial: Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer

Summary: RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
  PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
  Secondary
  -  To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
  OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
  Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets any of the following criteria:
  -  Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
  -  Patients who meet Amsterdam I, II, or Bethesda criteria
  -  Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
  -  Patients diagnosed with colorectal cancer at < 50 years old
  -  Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry
  PATIENT CHARACTERISTICS:
  -  See Disease Characteristics
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Detection of Colorectal Cancer in Peripheral Blood by Septin 9 DNA Methylation Assay

Summary: Epigenomics is developing a colon cancer screening assay based on differential methylation of specific CpG sites for the detection of early stage disease. A genome-wide methylation analysis and oligonucleotide array study using DNA from various stages of colon cancer and normal tissue have been completed to obtain candidate CpG markers. Based on results obtained in the above studies, Epigenomics has moved to the final stages of feasibility with a specific, highly sensitive real-time marker assay that is able to detect colon cancer DNA in blood plasma.

Detailed description: From public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of CRC screening initiatives; as stated by Sidney Winawer, MD, "the best test is the one that gets done." Current CRC screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 16% in the US) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for CRC detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
  Epigenomics has identified methylated gene regions that are specific for colorectal cancer or pre-malignant tissue. Aberrantly methylated genes represent attractive candidate markers for cancer screening, as cancer-specific methylation changes occur early in tumorigenesis, appear to be stable, yield a positive amplifiable signal, and can be assayed with high analytical sensitivity. Since methylation occurs early and in distinct genomic areas, it is possible to achieve high clinical sensitivity with a small number of methylated DNA markers. Studies have shown that aberrantly methylated DNA markers can be detected in tissue and body fluids and are highly correlated to colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Group 1 diagnosis of colorectal cancer
  Exclusion Criteria:
  -  Group 2 diagnosis of colorectal cancer

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

Clinical trial: Nitrous Oxide and Risk of Cancer Recurrence After Colorectal Surgery: A Randomized, Blinded Study

Summary: This study was developed to test the hypothesis that the risk of colorectal cancer recurrence was similar in patients who were randomly assigned to 65% nitrous oxide or nitrogen during colorectal surgery.

Detailed description: We conducted a 4- to 8-year follow-up of 204 patients with colorectal cancer who were randomly assigned to 65% nitrous oxide (n=97) or nitrogen (n=107), balanced with isoflurane and remifentanil. The primary outcome was the time to cancer recurrence. Our primary analysis was a multivariable Cox-proportional-hazards regression model that included relevant baseline variables. In addition to treatment group, the model considered patient age, tumor grade, dissemination, adjacent organ invasion, vessel invasion, and the number of nodes involved. The study had 80% power to detect a 56% or greater reduction in recurrence rates (i.e., hazard ratio of 0.44 or less) at the 0.05 significance level.

Eligibility: Inclusion Criteria:
  -  Subjects age 18-18
  -  ASA status 1-3
  -  Informed consent
  Exclusion Criteria:
  -  Acute bowel obstruction
  -  Minor colon surgery

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

Clinical trial: The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Summary: Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age.
  Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil.
  The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes.


Eligibility: Inclusion Criteria:
  -  Stable weight (< 5% variation) within the last three months
  -  Age: 35 to 50 years old for middle-age group, and 65 to 80 years old for elderly group.
  -  BMI: 20 to 29.9 kg/m2
  -  Normal glucose tolerance (NGT) for groups Elderly and Middle-age
  Exclusion Criteria:
  -  Use of estrogen, progestogen or systemic corticosteroids.
  -  Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity
  -  Smoking
  -  Obesity
  -  Uncontrolled systemic or debilitating diseases

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

Clinical trial: Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?

Summary: The purpose of this randomised intervention study is to investigate to what degree patients with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic treatment and quality of life.


Eligibility: Inclusion Criteria:
  -  metastatic colorectal cancer
  -  histological verified cancer
  -  age >18 years
  Exclusion Criteria:
  -  cognitive reduction
  -  confusion
  -  not able to answer questionaire

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

Clinical trial: Gene Expression in Patients With Advanced or Metastatic Colorectal Cancer Receiving Bevacizumab

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment.
  PURPOSE: This laboratory study is looking at gene expression in patients with advanced or metastatic colorectal cancer receiving bevacizumab.

Detailed description: OBJECTIVES:
  -  Determine whether the balance of splice form expression alters susceptibility of tumors in vivo to respond to anti-VEGF therapy.
  OUTLINE: Tumor tissue samples collected on clinical trial E-3200 are analyzed for laboratory endpoints.

Eligibility: DISEASE CHARACTERISTICS:
  -  Tumor tissue samples available from patients with advanced or metastatic adenocarcinoma of the colon or rectum
  -  Receiving bevacizumab on clinical trial E-3200
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Studying DNA and Outcome in Patients With Advanced Colorectal Cancer Treated With Fluorouracil and Oxaliplatin With or Without Bevacizumab on Clinial Trial E-3200

Summary: RATIONALE: Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.
  PURPOSE: This laboratory study is analyzing the DNA in tissue samples from patients with advanced colorectal cancer treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.

Detailed description: OBJECTIVES:
  -  Determine the CpG island methylation pathway markers that are adverse for survival after treatment with fluorouracil in patients with advanced colorectal adenocarcinoma treated with fluorouracil and oxaliplatin with or without bevacizumab on clinical trial E-3200.
  -  Compare the methylation results to clinicopathologic and molecular findings and survival.
  OUTLINE: This is a multicenter study.
  Tissue, blood, and urine samples and genomic DNA samples from tumor tissue blocks are examined by pyrosequencing assay for methylation. Genes examined include MINT1, MINT31, P14, and P16. Microsatellite instability and loss of heterozygosity (LOH) on chromosome 18 (18q LOH) are also assessed. Microsatellites examined include BAT loci, TGFβRII, D2S123, D55346, and D17S250.
  PROJECTED ACCRUAL: A total of 350 specimens will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of adenocarcinoma of the colon or rectum
  -  Advanced disease
  -  Enrolled on clinical trial E-3200 and received fluorouracil and oxaliplatin
  -  Tumor tissue blocks available
  -  Routine pathology specimens (i.e., blood, urine) available
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Use of Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)

Summary: Familial Adenomatous Polyposis (FAP) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. Virtually, all patients with FAP will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. Besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum.
  Use of nonsteroidal anti-inflammatory drug (NSAID), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (COX-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with FAP. However, use of NSAIDs and COX-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. Therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. Therefore the following specific aim has been proposed:To determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with FAP.

Detailed description: Patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). Besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

Eligibility: Inclusion Criteria:
  -  21-85 years with FAP (with an intact colon or who have had surgery)
  Exclusion Criteria:
  -  Mentally incompetent
  -  Female patients of childbearing age not on effective birth control
  -  Patients with WBC < 3,500/ml, platelet count < 100,000/ml, BUN > 25mg%, creatinine > 1.5mg%
  -  Patients unable to stop NSAIDS or aspirin use for the duration of the study
  -  Malignancy other than nonmelanoma skin cancer
  -  Active bacterial infection
  -  Patients with GERD (Gastro esophageal reflux disease)
  -  Patients with a history of peptic (stomach or duodenal) ulcer disease
  -  Patients 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: A Study of Lymphangiogenesis in Colorectal and Nasopharyngeal Cancer

Summary: 1. To determine the association between LVD and clinico-pathologic variables in archived colorectal cancer and Nasopharyngeal carcinoma specimens
  2. To determine the association between VEGF-C,-D expression with COX-2 expression and clinico-pathologic variables in colorectal cancer and Nasopharyngeal carcinoma
  3. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma Lymphangiogenesis and factors modulating lymphangiogenesis are associated with clinico-pathological outcome in Nasopharyngeal carcinoma and colorectal cancer. Celecoxib down-regulates lymphangiogenesis Archival colorectal cancer and Nasopharyngeal carcinoma tumor specimens will be obtained from the Department of Pathology. To determine the effect of celecoxib on lymphangiogenesis in Nasopharyngeal carcinoma, the investigators intend to analyze archived specimens collected in a previously conducted study. Colorectal tumor and nodal specimens and Nasopharyngeal carcinoma primary will be examined for MVD, LVD and growth factor expression using established haematoxylin and eosin and immunohistochemical techniques. Quantification of LVD and MVD shall be performed by two pathologists blinded to clinico-pathological variables using standardised methods.


Eligibility: Inclusion Criteria:
  -  Male and female patients are eligible
  -  Patients 21 years or older
  Exclusion Criteria:

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

Clinical trial: Processed Meat and Colon Carcinogenesis

Summary: Colorectal cancer kills forty five people in France every day. Epidemiological studies suggest that two cases out of three could be prevented and show that processed meat intake is a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to find protective strategies, and to make compelling dietary recommendations.

Detailed description: 18 healthy volunteers will be randomized and will start the study. The study will last 4 weeks for each subject. The first week will be a week of adaptation (or run-in period) to the diet which they will have to follow for the duration of study. During this period, they will collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will separate every period (wash-out) of nutritional intervention. Urines and stools will be collected last 3 days of every interventional period and also last day of every wash out period.

Eligibility: Inclusion Criteria:
  -  Male
  -  Body mass index 20 <= BMI <= 30 kg/m2
  -  Affiliated to French National Health Insurance
  -  Subject giving his written informed consent
  -  Subject considered as normal after clinical examination and medical questionnaire
  Exclusion Criteria:
  -  Positive serologies to HIV or HCV, determined on blood samples
  -  Previous medical and/or surgery judged by the investigator as incompatible with this study
  -  Previous familial of colon, ovarian or breast cancer
  -  Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
  -  Dislike ham
  -  Heavy consumer of alcohol
  -  Practising intensive physical exercise
  -  Being under someone's supervision
  -  Refusal to be registered on the National Volunteers Data file
  -  Dietary habits unreliable to controlled food intake
  -  Being in exclusion on the National Volunteers Data file

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

Clinical trial: Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)

Summary: This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 patients.


Eligibility: Inclusion Criteria:
  -  adult patients =/<18 years of age
  -  metastatic colorectal cancer
  -  patients for whom the physician has prescribed bevacizumab [Avastin] for the treatment of 1st line metastatic colorectal cancer
  -  patients, who have given written informed consent
  Exclusion Criteria:
  -  hypersensitivity to recombinant human or humanised antibodies
  -  pregnancy or breast-feeding

Relevance to patient case: not relevant