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

Clinical trial: cKIT, BRAF/NRAS Mutations in Advanced Melanoma : Clinical Outcome in Response to Tyrosine-kinase Inhibitors - KitMel Project

Summary: Background: Metastatic melanoma has a devastating prognosis and is one of the top causes of cancer death in young patients. Until now, available therapies were few and unreliable, but recent understanding of melanomas' molecular pathways has improve their classification and new clinical strategies have been proposed.
  Initial studies showed that B-Raf/N-Ras mutations (respectively V600E and Q61) are the most frequent alteration being present in 70 to 80% of melanomas, characterizing non Chronic Sun-induced Damage skins (CSD). These include Superficial Spreading Melanomas (SSM) and Nodular Melanomas (NM). Other studies showed that c-Kit mutations are presently the predominant activating mutation (20 - 40 %) in Acro-Lentiginous Melanomas (ALM), Mucous Melanomas (MM) and in melanomas arising on CSD skin. c-Kit mutation pattern is more complex with four exons being affected leading to different mutations, which incidence and biological impact are less documented.
  BRAF/NRAS genetics alterations drive constantly cell growth, being thus attractive targets. Spectacular results have indeed been obtained with the BRAF inhibitor that targets the V600E BRAF-mutated form. Data from GIST disease revealed that the different c-Kit mutations modulate differently c-Kit function and the response to targeted therapies.
  Because c-Kit targeted therapy is a critical clinical issue, the investigators aimed to identify the most frequent mutations present in our population to propose appropriate screening test and adapt the therapy.
  Methods: 250 melanoma samples corresponding to an homogeneous white-Caucasian population (Brittany, France) will be screened. c-Kit exons 11, 13, 17 and 18 will be sequenced (direct sequencing and pyrosequencing when possible). c-Kit copy number will be quantified by q-PCR and level of c-Kit determined by immunohistochemistry (IHC, CD117). Samples will also be analyzed for B-Raf mutations in codon 464, 466, 469 and 600, and for N-Ras mutations in codon 12, 13 and 61 (Pyrosequencing).
  Expected Results:
  Taken together, the investigators anticipate that the present genetic analysis of the tumours from patients with advanced melanoma will first document the type and frequency of cKit mutations, will confirm or not that BRAF, NRAS and cKit mutations are mutually exclusive and document their repartition in the melanomas sub-types. Finally this study will clue researchers in to how well patients will respond to a therapy that targets the growth-promoting proteins BRAF/NRAS and cKIT.


Eligibility: Inclusion Criteria:
  -  melanoma
  -  white caucasian population

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

Clinical trial: Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients

Summary: The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.

Detailed description: To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.

Eligibility: Inclusion Criteria:
  -  Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA
  Exclusion Criteria:

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

Clinical trial: Patient Activation Intervention in Improving Screening Rates for Colorectal Cancer

Summary: This randomized clinical trial focused on activating the patient to ask their health care provider for a colorectal cancer screening test to improve screening rates for colorectal cancer. The patient activation intervention may increase information seeking, number of screening tests ordered and number of completed screening tests for colorectal cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To test a patient activation intervention to improve colorectal cancer (CRC) screening rates using fecal occult blood test (FOBT) among male and female patients 50 years and older from the East Central Columbus Neighborhood Health Center.
  SECONDARY OBJECTIVES:
  I. To assess if there is a change in knowledge and attitudes about CRC screening after watching the educational video.
  II. To assess the effectiveness of providing communication skills training for improving discussion focusing on CRC screening during the patient-provider visit.
  OUTLINE: Patients are randomized to 1 of 2 arms prior to a medical visit.
  ARM I (Education only): Patients receive CRC and CRC screening information by an educational video and a brochure with healthy hints to prevent CRC.
  ARM II (Education and patient activation): Patients receive CRC and CRC screening information and communication skills training (patient activation) intervention by educational video and brochure and a brochure about healthy hints to prevent CRC.
  After the medical visit, patients' medical records are reviewed at 1 month and 2 months after the visit to document CRC screening completion.

Eligibility: Inclusion Criteria:
  -  Patient is 50+ years of age
  -  Patient is in need of CRC screening
  -  Patient is in good health (e.g. no contraindications to having CRC screening, such as a history of colorectal cancer, congenital heart failure, renal failure, dialysis, dementia, severe arthritis, etc.)
  -  Patient is not pregnant
  -  Patient is able to speak, read, and understand English
  Exclusion Criteria:
  -  Patient is within CRC screening guidelines
  -  Patient is at high risk for CRC
  -  Patient cannot understand English
  -  Patient cannot complete a CRC screening test

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

Clinical trial: A Phase 2 Study of Panitumumab in Patients With Cetuximab-refractory Metastatic Colorectal Cancer

Summary: The purpose of this study is to assess if panitumumab is active enough to warrant comparative studies in patients with metastatic colorectal cancer that has progressed after treatment with cetuximab.

Detailed description: The study was amended with modification of inclusion criteria (from wild-type tumor KRAS gene to wild-type RAS gene, including KRAS and NRAS exons 2, 3 and 4)
  RAS mutational status of tumors of patients enrolled before amendment 1 approval will be centrally revised. Patients whose tumors will result RAS mutated at the biomarkers central revision, will be replaced. Therefore, the overall sample size at both the stages may be higher than the one initially planned.

Eligibility: Inclusion Criteria:
  -  Pathologic diagnosis of metastatic colorectal adenocarcinoma
  -  a wild-type RAS tumor (mutational status has to be determined by an experienced laboratory using validated test methods for detection of KRAS exons 2, 3, and 4, and NRAS exons 2, 3, and 4
  -  Failure from previous treatment with fluoropyrimidine, oxaliplatin and irinotecan. Patients may or may not have been treated with bevacizumab.
  -  Documented disease progression following a treatment with cetuximab in patients who showed either an objective response after 8 weeks or stable disease after 16 weeks of cetuximab treatment.
  -  Age at least 18 years
  -  ECOG Performance Status 0-2
  -  Neutrophils at least 1,500 mm3, platelets at least 100,000 mm3, and hemoglobin at least 9 g/dL
  -  Bilirubin level less than 1.5 times ULN
  -  AST (SGOT) and ALT (SGPT) not greater than 2.5 times ULN (or 5 times ULN in presence of liver metastasis)
  -  Serum creatinine less than 1.5 times ULN
  -  Effective contraception, if the risk of conception exists
  -  Life expectancy at least 3 months
  -  Written informed consent
  Exclusion Criteria:
  -  Symptomatic brain metastasis
  -  Interstitial pneumonitis or pulmonary fibrosis
  -  Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
  -  Chemotherapy, radiotherapy or immunotherapy within the past 4 weeks
  -  Any unstable systemic disease (including active infections, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study drugs or render the patient at high risk from treatment complications
  -  Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment

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

Clinical trial: Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Summary: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Detailed description: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Eligibility: Inclusion Criteria:
  Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression
  Exclusion criteria:
  Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2

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

Clinical trial: A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Summary: This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.


Eligibility: Inclusion Criteria:
  -  KRAS and NRAS wild type metastatic colorectal cancer
  -  Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting.
  -  Eastern Cooperative Oncology Group [ECOG] Performance Status of 0, 1, or 2
  -  At least one measurable lesion by Response Evaluation Criterion in Solid Tumors [RECIST]
  Exclusion Criteria:
  -  More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer.
  -  Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor
  -  Patients who have discontinued treatment with prior irinotecan therapy due to toxicity.
  -  Prior radiation to the pelvis or abdomen
  -  Patients with history of interstitial lung disease.

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

Clinical trial: A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Summary: This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI.
  The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.


Eligibility: Inclusion Criteria:
  -  Advanced colorectal carcinoma.
  -  Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
  -  Tumor tissue available at time of screening for molecular profiling.
  -  Adequate performance status.
  -  Adequate glucose control, bone marrow, kidney, liver, and heart function.
  Exclusion Criteria:
  -  Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
  -  Prior irinotecan treatment.
  -  Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
  -  History of Gilbert's syndrome.
  -  Active brain metastases.
  -  Deep vein thrombosis in the preceding 2 months.
  -  History of interstitial lung disease.
  -  RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).

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

Clinical trial: Effectiveness of WB-EMS Versus HIT-Resistance Training (RT)

Summary: The main aim of the study is to determine the effects of Whole-Body Electromyostimulation (WB-EMS) on body composition and muscle strength compared with the "golden standard" High Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.


Eligibility: Inclusion Criteria:
  -  male, 25 to 55 years old
  -  sedentary / untrained
  -  Body Mass Index 20 - 30 kg/m2
  Exclusion Criteria:
  -  absent ≥ 2 weeks during the interventional period
  -  medication or diseases with relevant impact on muscle metabolism
  -  conditions that prevent WB-EMS (e.g. epilepsy, cardiac pacemaker)
  -  severe neurological diseases

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

Clinical trial: Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities

Summary: This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.

Detailed description: PRIMARY OBJECTIVES:
  I. Assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for African Americans in the two communities.
  II. Using a Community-Based Participatory Research (CBPR) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in African Americans.
  III. Examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence African Americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking.
  IV. Examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (CRC) screening and health care seeking behaviors.
  OUTLINE: Program locations are randomized to 1 of 2 arms.
  ARM I: Participants view videos with information about CRC and screening delivered by personal narrative.
  ARM II: Participants view videos with information about CRC and screening delivered by informative fact-based message.
  After completion of study, patients are followed up at 3 and 6 months.

Eligibility: Inclusion Criteria:
  -  Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
  -  EDUCATIONAL INTERVENTION:
  -  Currently non-adherent to colorectal cancer screening
  -  Self-identify as African American
  -  Are 50 years of age or older
  -  Have the ability to provide informed consent in English
  -  FOLLOW-UP ASSESSMENTS:
  -  Must be non-adherent for CRC screening at the time of the educational program
  -  Have telephone service (mobile or landline), to participate in the follow up interviews
  -  Agree to providing consent for release/review of their medical record
  Exclusion Criteria:
  -  Non-English speaking

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

Clinical trial: The Oncopanel Pilot (TOP) Study

Summary: The BCCA Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes.
  The purpose of this pilot study is to assess the feasibility and effect on clinical-decision-making of the Oncopanel test. Eligible patients are those with advanced lung, colorectal, melanoma and GIST cancers and patients with diagnosed malignancies being considered for clinical trials.

Detailed description: Somatic mutations in solid tumors represent an established means of characterizing malignancies for prognostic, diagnostic and therapeutic purposes. Mutations in EGFR, KRAS, BRAF, and KIT and PDGFRA genes direct therapy in patients with advanced lung, colorectal, melanoma, and GIST tumors, respectively. Known or novel mutations in other genes may also be of clinical significance but are not identified by current genotyping offered to BC Cancer Agency (BCCA) patients. Furthermore, numerous candidate genes have been implicated as potential prognostic and predictive biomarkers in patients with solid tumours. As such, the Oncopanel is a clinical assay being developed to determine genotype status of a prospectively defined set of genes. The following clinically relevant set of genes and exons are included in the Oncpanel: KRAS, EGFR, BRAF, NRAS and HRAS, PIK3CA Signal Transduction Pathway Genes, RAS-RAF-MEK-MAPK Pathway, HER2, IDH1 and IDH2, ALK, TP53, c-KIT, STAT1&3 and PDGFRA. Additional testing on the tumour material will also include analysis of specific gene variants associated with adverse events or response to therapy.
  Numerous studies have documented the presence of circulating tumour DNA (ctDNA) among patients with advanced and early stage malignancies (20-22). The ability to diagnose standard cancer mutations with a blood-based assay (a "liquid biopsy") has not yet been established but presents obvious advantages. The emergence of "resistance" mutations arising in the metastatic tumor or throughout the course of therapy is well documented (21, 22). A blood biopsy may represent more accurate determination of the tumor's genetic features than archival DNA specimen. Adequate tissue specimens can be difficult to obtain from some patients with diagnosed malignancies, particularly lung cancer. A blood biopsy may represent a less invasive and timelier means of diagnosing both standard and translational cancer mutations.

Eligibility: Patients with archival tumor tissue and a known history of invasive malignancies are eligible if they meet one or more of the following criteria:
  -  Advanced colorectal cancer and eligible for standard KRAS testing,
  -  Advanced non-small cell lung cancer and eligible for standard EGFR testing,
  -  Advanced melanoma and eligible for standard BRAF testing,
  -  Gastrointestinal stromal tumors (GISTs) eligible for standard c-KIT and PDGFRA testing,
  -  Being considered for potential eligibility in clinical trial.

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

Clinical trial: Optimizing Navigation to Successful Colorectal Cancer Screening

Summary: Colorectal cancer is the second leading cause of death from cancer in the United States. Two major barriers to successful colorectal cancer screening are appointment keeping and proper bowel preparation. The purpose of this study is to test the efficacy of a patient navigation program to increase colorectal cancer screening at Rush University Medical Center. The investigators hypothesize that colorectal cancer screening will be improved for subjects who utilize a patient navigator.


Eligibility: Inclusion Criteria:
  -  Subject deemed appropriate for colorectal cancer screening by colonoscopy by a primary care physician
  -  Age 50 or greater or 40 or greater with family history of colorectal cancer in first degree relative
  -  Average risk for screening as defined as absence of symptomatic abdominal pain and active GI bleeding
  Exclusion Criteria:
  -  Age > 75 years old
  -  Congestive Heart Failure
  -  Chronic Obstructive Pulmonary Disease
  -  Myocardial Infarction
  -  Weight greater than 350 pounds
  -  Anticoagulation
  -  Inability to speak English

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

Clinical trial: Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

Summary: This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.


Eligibility: Inclusion Criteria:
  -  Informed consent provided
  -  Age > or = to 18 years of age
  -  Patient group FAP
  - Clinical diagnosis of familial adenomatous polyposis
  -  Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome
  -  Patient group MAP
  - Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps
  -  Control group (FAP)
  - Genetically related family member of patient
  -  Patients: Able and willing to attend routine follow-up as advised
  -  Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative
  Exclusion Criteria:
  -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
  -  Current diagnosis of colorectal cancer
  -  Pregnancy

Relevance to patient case: not relevant