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

Clinical trial: Expandability of Aging Adipose Tissue

Summary: The purpose of this pilot study is to determine whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men. The investigators hypothesize that the adipose tissue response to overfeeding may be weakened in older when compared to younger men, thereby leading to worsened ectopic storage depots for older men.

Detailed description: This pilot study will begin to address whether adipose tissue biology changes with advancing age. Specifically, we will test whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men. To test this possibility the Investigators will recruit overweight and mildly obese older (age 55-75y) and younger (age 25-40y) men and collect adipose tissue biopsies before and after 7 days of overfeeding. The investigators will test how well the cells in adipose tissue expand in response to overfeeding and whether this differs between younger and older men.

Eligibility: Inclusion Criteria:
  -  Men
  -  Aged 25-40y OR 55-75y
  -  BMI 28-35 kg/m2
  -  Weight stable (±2kg over past 3 mo)
  -  Sedentary to moderately active (<3 d/wk of exercise lasting >20min)
  -  Non-smokers (never used or quit >7yrs prior)
  Exclusion Criteria:
  -  Women
  -  Currently using hormones, glucose or lipid lowering medication
  -  Engaged in exercise or diet program
  -  Currently gaining or losing weight or using weight loss drugs
  -  Diabetes mellitus (diagnosis, treatment, FBG ≥126 mg/dL)
  -  Uncontrolled metabolic disorders (e.g., thyroid)

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

Clinical trial: Usefulness of Chromoendoscopy for the Early Detection of Colorectal Cancer Associated With Inflammatory Bowel Disease

Summary: To assess the feasibility and effectiveness of a program in L-IBD patients using CE targeted biopsies

Detailed description: We aim to know the prevalence and incidence of dysplasia and colitis-associated colorectal cancer in patients with longstanding colonic inflammatory bowel disease (N-IBD), in Spain and the usefulness of advanced endoscopy (chromoendoscopy) for the diagnosis and endoscopic differential diagnosis of N-IBD.

Eligibility: Inclusion Criteria:
  -  Diagnosis of UC or colitis EC corroborated by clinical and histology
  -  involvement of at least one third of the colon in patients with CD
  -  involvement proximal to the rectum in patients with UC
  -  Duration of disease > 10 years
  -  No clinical activity:
  -  May Score <6
  -  CDEIS <3.5
  Exclusion Criteria:
  -  Personal history of CRC
  -  colectomy
  -  coagulopathy
  -  refusal to participate in the study
  -  known allergy to indigo carmine
  -  colonoscopy in the last 6 months

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

Clinical trial: Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Summary: This is a phase 1b/2a study investigating the safety and effect of Sym004 in combination with FOLFIRI (chemotherapy) when administered every second week.
  The phase 1b (dose-escalation) portion of the trial is expected to begin Q1 2016. Patients will be sequentially enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.
  The phase 2a (dose-expansion) portion of the trial is expected to begin after establishing the RP2D.


Eligibility: Main inclusion Criteria:
  1. Male or female, at least 18 years of age at the time of informed consent
  2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or Neuroblastoma rat sarcoma (NRAS) gene mutations (i.e. tumors must express the KRAS and NRAS wild type (WT), exon 2, 3 and 4).
  4. Failed* treatment for locally advanced or metastatic disease with first-line combination therapy of oxaliplatin and a fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after the last dose of first-line therapy and within < 3 months of C1/D1.
  Patients who discontinued first-line therapy due to toxicity may be enrolled provided progression occurred < 6 months after the last dose of the first-line therapy regimen.
  or Failed* adjuvant therapy with combination therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months after the last dose of oxaliplatin and within < 6 months of C1/D1.
  -  Failure is defined as radiologic progression
  5. Eligible for FOLFIRI
  6. Measurable disease according to RECIST v1.1
  Main exclusion Criteria:
  1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or irinotecan (CPT-11)
  2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1
  3. Significant gastrointestinal abnormalities
  4. Patients with a significant cardiovascular disease or condition
  5. Abnormal hematologic, renal or hepatic function

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

Clinical trial: Colorectal Cancer Study: Screening v.s. Other Diagnostics

Summary: The purpose of this study is to determine whether colorectal cancer diagnosed by screening (primary screening colonoscopy, colonoscopy after FOBT) has a better pTNM classification than colorectal cancer diagnosed byl other diagnostics (diagnostic colonocopy, CT, MR etc.).

Detailed description: Multicentre prospective observational study. 12 centres across the Czech rep. included. Study approved by Ethical Committee. Informed consent signed by every patient. Study coordinator in each centre. Patient registry availble in every centre. Patient informations stored under ID in secured internet database (RedCap) run by ICRC (The International Clinical Research Center of St. Anne's University Hospital Brno). Statistical validation of data and analysis (descriptive statistics, two-sample T-Test, Mann-Whitney test, Fisher exact test and Chi-Square test).

Eligibility: Inclusion Criteria:
  -  newly diagnosed colorectal cancer
  Exclusion Criteria:
  -  unsigned informed consent
  -  mental disorder

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

Clinical trial: Detection of KRAS, NRAS et BRAF Mutations in Plasma Circulating DNA From Patients With Metastatic Colorectal Cancer

Summary: RAS genotyping is mandatory for the prescription of anti-EGFR (epidermal growth factor receptor) therapies in patients with metastatic colorectal cancer. The standard genotyping is assessed on formalin-fixed paraffin embedded tumour tissue. This study compares RAS and BRAF genotyping results achieved in analyzing circulating plasma DNA using OncoBEAM™ technique with those achieved using the standard genotyping techniques and formalin-fixed paraffin embedded samples.

Detailed description: The study will be proposed to all patients with a metastatic colorectal cancer.
  Study information will be given to the patient during a routine medical examination. The patient will be included after checking inclusion criteria and signature of the informed consent form
  Blood sampling (30 ml) will be performed before the initiation of the first line metastatic chemotherapy.

Eligibility: Inclusion Criteria:
  -  Adult subjects with newly diagnosed, anti EGFR treatment naïve metastatic colorectal cancer
  -  Standard of Care RAS/RAF tests performed on FFPE tumor sample as part of routine
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  -  Age : 18 years and older
  Exclusion Criteria:
  -  Patient bearing non-metastatic colorectal cancer
  -  Patient with local relapse only
  -  Patient with exclusive nodal metastases
  -  Patient whose health contraindicates a 30 ml blood sample
  -  Blood transfusion within 1 week prior blood collection
  -  Patient having received any chemotherapy or / and radiotherapy within 15 days prior to blood collection
  -  History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix
  -  Persons deprived of liberty or under supervision

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Epidemiological and Molecular Colorectal Cancer Registry

Summary: This is a Registry that invites patients undergoing colorectal surgery for colorectal cancer. Epidemiological data is collected. The Registry includes tumor tissue and blood banks for analyzing different genetic mutations and disease-specific biomarkers.


Eligibility: Inclusion Criteria:
  -  Adult patients undergoing colorectal surgery for colorectal cancer.
  Exclusion Criteria:
  -  Unwillingness to participate.

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

Clinical trial: Evaluation of MM-151 + Nal-IRI + 5-FU + Leucovorin in RAS/RAF Wild-type Metastatic Colorectal Cancer

Summary: A phase 1b/2a study evaluating the combination of MM-151 + nal-IRI + 5-FU + Leucovorin in RAS/RAF wild-type Metastatic Colorectal Cancer.

Detailed description: Part 1: Patients will be enrolled to determine the maximum tolerated dose, safety and tolerability of MM-151 + nal-IRI + 5-FU + LV in patients with mCRC that are RAS/RAF wild-type.
  Part 2: Patients will be enrolled at the maximum tolerated dose of MM-151 in combination with nal-IRI + 5-FU + LV to characterize initial efficacy in conjunction with levels of irinotecan and SN-38 measured in tissue.

Eligibility: Inclusion Criteria:
  -  Patients must be greater than 18 years of age
  -  Patients must be able to provide informed consent
  -  Patients must have KRAS/NRAS/BRAF wild-type colorectal cancer
  -  Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 120 days following the last dose of any study therapy). This applies to women of childbearing potential as well as fertile men and their partners
  Exclusion Criteria:
  -  Patients who have had previous pelvic radiation treatment
  -  Patients who are pregnant or lactating
  -  Patients who have untreated (primary) or uncontrolled Central Nervous System (CNS) (primary or metastatic) malignancies; patients with CNS metastases who have undergone surgery or radiotherapy or who have been on a stable dose of corticosteroids for at least 2 weeks and whose disease is stable prior to the first scheduled day of dosing will be eligible for the trial.
  -  History of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible.
  -  Patients who have received other recent antitumor therapy including any standard chemotherapy or radiation within 14 days and bevacizumab within 28 days (and having passed the time of any actual or anticipated toxicities) prior to the first scheduled dose of the study treatment

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Simo Decoction and Acupuncture on POI in Colorectal Cancer

Summary: Colorectal cancer resection is one of the most common types of abdominal surgery. Though most patients undergoing colorectal resection show recovery of bowel movements within a week, some have prolonged intestinal paralysis or postoperative ileus, resulting in decreasing patient comfort, increasing morbidity and mortality, a longer hospital stay and subsequent increased healthcare costs.

Detailed description: Prevention the incidence of postoperative ileus (POI) is quite important because of the negative clinical outcomes it causes. In the past two decades, many treatments and care approaches, such as fluid restriction, early enteral nutrition, and nonsteroidal anti-inflammatory drug are used for the management of POI. In theory of traditional Chinese medicine, oral simo decoction (SMD) or acupuncture at the tsusanli acupoint can boost gastrointestinal hypomotility. The efficacy of accelerating the return of gastrointestinal function by such single method or combination of them has been validated in randomized controlled trials and systematic review following several types of surgery. In recent years, chewing gum, a new and simple modality, has become a commonly applied method in order to prevent and reduce the POI. Systematic reviews and meta-analyses revealed that chewing gum provided significant benefits for the improvement of postoperative bowel function. More importantly, many official guidelines recommend chewing gum for an evidence-based approach in the prevention of POI. Despite these positive evidence, three newest randomized controlled trials are unable to demonstrate an effect of chewing gum on the recovery of bowel function after colorectal resection.
  It is important to note that almost all previous randomized controlled trials are based on small sample size. This raises the question whether postoperative SMD, acupuncture at the tsusanli acupoint, or chewing gum can reduce risk of POI following colorectal resection among patients with large sample size. To examine this question, we conducted this randomized controlled trial to compare incidence of POI and length of hospital stay in colorectal cancer patients who received SMD and acupuncture, chewing gum or no intervention following resection.

Eligibility: Inclusion Criteria:
  -  Underwent open or laparoscopic colorectal cancer resection
  -  Diagnosis of colorectal cancer was confirmed by histopathological examination of surgical samples in all patients
  Exclusion Criteria:
  -  Previously underwent exploratory laparotomy
  -  Known Central Nervous System tumors including metastatic brain disease
  -  History of organ allograft
  -  Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  -  Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  -  Pregnant or breast-feeding patients

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

Clinical trial: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer

Summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility: Inclusion Criteria:
  -  Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
  -  Age ≥ 18 years
  -  Patient information and written informed consent form signed
  -  Patient must be affiliated to a social security system
  Exclusion Criteria:
  -  Patients whose health-cons indicates a blood sample 10mL
  -  Age < 18 years
  -  Pregnant or breast feeding females
  -  Persons deprived of liberty or under supervision

Relevance to patient case: definitely relevant
Patient case: 49-year-old male with colorectal cancer; genetic feature: NRAS

Clinical trial: Institut Paoli Calmettes Colorectal Cancer Database

Summary: Database of Institut Paoli-Calmettes patients diagnosed with colorectal cancer


Eligibility: Inclusion Criteria:
  -  Patients with a colorectal cancer diagnosis
  Exclusion Criteria:
  -  Non applicable

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

Clinical trial: Intestinal Stem Cells Characterization

Summary: A monocentric pilot studying intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC.

Detailed description: Intestinal organoids are 3D mini-guts produced in vitro based on intestinal stem cell (ISC) capabilities. These organoids contain all of the intestinal epithelial cells. The renewal of the two kinds of ISCs, which are present at the bottom of intestinal crypts, is controlled by Wnt/APC/beta-catenin pathway. Mutations of genes involved in this pathway are found in intestinal polyposes like familial adenomatous polyposis (FAP, APC gene).
  This model is of interest to study early pathophysiological events occurring within intestinal epithelium, in the context of FAP and inflammatory bowel diseases (IBD). An excessive proliferation or an abnormal healing is found in FAP and IBD respectively. Investigators hypothesized that it could specifically involved one of the 2 ISCs. Columnar basal cells (CBC) and ISC located at the +4 position from the bottom of the crypt (ISC+4) can both differentiate into absorptive or secretory intestinal epithelial cells. However, CBC and ISC+4 could have different metabolic, migratory functions, or stress survival.
  Investigators designed a monocentric pilot study to develop intestinal organoids from endoscopic biopsies of IBD (Crohn and ulcerative colitis), FAP patients and healthy controls. Investigators plan to investigate the morphological characteristics of organoids, the expression of genes and proteins of the Wnt/APC/beta-catenin pathway within both ISC. Will also be studied the expression of key genes of tumor initiation (PTEN, BMPR1A, p53 and KRAS) and inflammatory parameters (cytokines and lipid mediators).
  The results of this study could improve the understanding of intestine renewal. Later on, the development of new drugs could beneficiate to IBD and FAP patients.

Eligibility: Inclusion Criteria: patient must have a coloscopy for intestinal pain -
  Exclusion Criteria: cancer

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

Clinical trial: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

Summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility: Inclusion Criteria
  Patient:
  -  Men aged 20 to 65 years
  -  Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
  -  With an AHI > 5 / h
  Healthy volunteers:
  -  Men aged 20 to 65 years
  -  With an AHI ≤ 5 / h
  Exclusion Criteria
  All subjects:
  -  Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
  -  Known cardiovascular disease associated (heart failure, rhythm disorder ...)
  -  Known respiratory diseases
  -  Known neoplastic pathology, known chronic inflammatory disease
  -  Psychiatric pathology treated
  -  Medication
  -  Not affiliated to the French social health care system
  -  Major protected person
  -  Private person of liberty
  -  People in emergency situation
  -  Patient refusing to participate in the study

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

Clinical trial: Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

Summary: This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).

Detailed description: This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:
  1. Opt-In - subject must actively choose to receive a home FIT kit.
  2. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

Eligibility: Inclusion Criteria:
  -  Between 50 to 74 years old
  -  Has received care at the Division of Internal Medicine
  -  Due for screening
  -  Asymptomatic for colorectal cancer (CRC)
  Exclusion Criteria:
  -  Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
  -  Has a history of CRC
  -  Has a history of other GI cancer
  -  Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
  -  Has history of colitis other than Crohn's disease or ulcerative colitis
  -  Has had a colectomy
  -  Has a relative that has been diagnosed with CRC
  -  Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  -  Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  -  Has iron deficiency anemia
  -  Has history of lower GI bleeding
  -  Has metastatic (Stage IV) blood or solid tumor cancer
  -  Has end stage renal disease
  -  Has cirrhosis
  -  Has heart failure
  -  Has dementia
  -  Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

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

Clinical trial: Investigation of the Role of the Microbiome in the Pathogenesis of Colorectal Adenoma and Carcinoma

Summary: The purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. For that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. Besides, a questionnaire about diet, lifestyle and medical history will be collected. Sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.


Eligibility: Lower GI endoscopy patients
  Inclusion Criteria:
  -  Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
  -  Male or female, aged 18 years or above
  -  Referred to lower GI endoscopy. Referral reasons can be among others:
  -  Positive FOBT (Fecal Occult Blood Test)
  -  Follow up after polypectomy
  -  Screening because of age
  -  Bleeding
  -  Abdominal pain
  -  Familial or past history of colon cancer or adenoma
  -  Abnormal imaging such as barium enema
  -  Change in bowel habits
  -  Both self-referrals, referrals from external GP or specialists and internal referrals can be included.
  Exclusion Criteria:
  -  Previous diagnosis of an inflammatory bowel disease
  -  Previous diagnosis of intestinal polyposis syndrome
  CRC patients
  Inclusion criteria:
  -  Participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed
  -  Male or female, aged 18 years or above
  -  Diagnosis of CRC for which resection is planned
  -  Both internal and external referrals from specialists can be included
  Exclusion Criteria:
  -  Previous diagnosis of an inflammatory bowel disease
  -  Previous diagnosis of intestinal polyposis syndrome

Relevance to patient case: not relevant