araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Follow up to the AVANT Study up to 8 and 10 Years (Median Follow up) in Patients With Colon Carcinoma

Summary: The aim of the S-AVANT study is to collect additional data at 8 and 10 years median follow up of patients previously included in the AVANT trial from December 2004 to June 2007.
  Clinical data of the AVANT trial will be updated. Neither additional examination nor administration of any treatment will be performed on the patients.
  330 centers in 34 countries participated to the AVANT trial (Australia, Austria , Belgium, Brazil, Bulgaria, Canada, China/Hong-Kong, Czeck Republic, Finland, France, Germany, Greece, Hungary, Israël, Italy, Japan, Korean Republic, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taïwan, Thaïland, United Kingdom, U.S.A).
  The AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer.
  Adverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms.
  A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.
  Collection of additional follow-up data will start Q3 2014. Clinical data are to be collected at 8-year median follow-up (expected to be reached around Q2 2014) and at 10-year median follow-up (expected to be reached around Q2 2016).
  All analyses will be performed on an exploratory purpose only. An analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the AVANT trial including patients lost to follow up or died).


Eligibility: Inclusion Criteria:
  -  All patients randomized in the AVANT trial.
  Exclusion Criteria:
  -  Written opposition from alive patients

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Safety Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Summary: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
  1. Main purpose
  1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
  2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
  2. Secondary purpose
  1. To observe tumor clinical benefit rate (CR+PR+SD).
  2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility: Inclusion Criteria:
  -  Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  -  Failed routine chemotherapy
  -  Neoplasms can be evaluated by imaging
  -  ECOG《2
  Exclusion Criteria:
  -  Have systematic chemotherapy in 2 weeks
  -  Be allergic to ultrasonic microbubbles and chemotherapeutics
  -  Uncontrolled high blood pressure, cardiovascular disease
  -  Active bleeding
  -  Have serious mental and psychological disease

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Exercise and Colon Cancer

Summary: Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.


Eligibility: Inclusion Criteria:
  1. histologically confirmed TNM stage II-III CC;
  2. completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
  3. ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
  4. age ≥18 years;
  5. written physician approval;
  6. no additional surgery planned within the 6-month intervention (including colostomy reversal);
  7. ability to walk unaided for 6-minutes;
  8. no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.
  Exclusion Criteria:
  1. history of another primary invasive cancer (other than non-melanoma skin-cancer);
  2. evidence of metastatic CC (i.e., TNM M1);
  3. planning to receive any additional adjuvant chemotherapy;
  4. pregnant or breast feeding;
  5. unable to provide baseline blood sample;
  6. cardiac conditions, including the following:
  1. myocardial infarction or coronary revascularization procedure within prior 3 months;
  2. uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
  3. high-risk or uncontrolled arrhythmias;
  4. clinically significant valvular disease;
  5. decompensated heart failure;
  6. known aortic aneurysm;
  7. any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Use of Exome Sequence Analysis and Circulating Tumour in Assessing Tumour Heterogeneity in BRAF Mutant Melanoma

Summary: Despite recent advances in cancer treatment, little impact has been made on curing as opposed to controlling cancers over the last several decades. Part of the problem is that investigators have an incomplete understanding of how tumours behave as they evolve and in response to treatment. In this trial, the investigators hope to better understand the evolution of BRAF melanoma in response to drugs a patient may have received such as vemurafenib or dabrafenib. Importantly, the investigators want to understand how the tumours evolve resistance to these drugs and whether this can be predicted through blood tests, in particular of the circulating tumour DNA.

Detailed description: Study population: BRAF mutant melanoma patients
  Pre-mortem bloods will be taken from the patient on three occasions at one to thirty days apart from each other, with the first blood draw taking place on the patient's first clinic visit. Six 7 ml EDTA and one 6 ml SST vacutainers of blood (a total of approx. 50 ml of blood) will be taken from the patient.
  When death is expected within the next 48-72 hours, the Medical Oncologist/ Radiation Oncologist/ Hematologist OR delegate will revisit the RAP process with the patient and/or family/substitute decision maker to ensure that they are still in agreement. The patient and the families will also be provided with an additional consent form for participation including blood sampling.

Eligibility: Inclusion Criteria:
  UHN adult patient with BRAF mutant melanoma
  Exclusion Criteria:
  Non BRAF mutant melanoma patient Pediatric patient Non-UHN patient

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Comprehensive Genomic Analysis in Tissue and Blood Samples From Young Patients With Lung Cancer

Summary: This research trial studies genomic analysis in tissue and blood samples from young patients with lung cancer. Identifying specific gene mutations (changes in deoxyribonucleic acid [DNA]) may help doctors tailor treatment to target the specific mutations and help plan effective treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To perform comprehensive genomic analysis of young lung cancer patients' samples to facilitate delivery of targeted therapies and clinical trial enrollment.
  II. To characterize the impact of young age at lung cancer diagnosis on the genomic landscape of primary lung cancer.
  III. To establish a prospective registry of young lung cancer patients for both tumor and germline next generation sequencing.
  OUTLINE:
  Tissue and blood samples are analyzed via next generation sequencing and whole exome sequencing.
  After completion of study, patients are followed up every 3 months for up to 3 years.

Eligibility: Inclusion Criteria:
  -  COHORT 1: LUNG CANCER PATIENTS
  -  Pathologically confirmed bronchogenic lung carcinoma (small cell lung cancer [SCLC] or non-small cell lung cancer [NSCLC] of any stage) at any treatment time point
  -  For individuals diagnosed with advanced disease (stage IV or recurrent) enrollment must occur within 2 years of diagnosis
  -  For appropriate patients (stage IV non-squamous NSCLC) epidermal growth factor receptor (EGFR ) and anaplastic lymphoma kinase (ALK) genotyping performed by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory is recommended prior to participation
  -  Provision of written informed consent
  -  Willingness to undergo a single blood draw
  -  Individuals who are under 18 are eligible for study if they meet the defined criteria for cohort 1; in addition, consent for participation must be given by a legal guardian or parent
  -  NOTE: to be eligible for genomics, availability of 10 unstained slides (plus hematoxylin and eosin [H&E] slide) or an adequate formalin-fixed paraffin-embedded (FFPE) tumor block from clinically indicated interventional procedures is required
  -  COHORT 2: DECEASED INDIVIDUALS
  -  Deceased individuals diagnosed with lung cancer at any age less than 40 may be studied on a case by case basis depending upon Institutional Review Board (IRB) approval at a participating institution; inclusion will require availability of adequate archived FFPE tissue and release of tissue and records by next of kin, if available
  Exclusion Criteria:
  -  Compromise of patient diagnosis or staging if tissue is used for research

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: A Trial of Aspirin on Recurrence and Survival in Colon Cancer Patients

Summary: The purpose of this study is to determine whether acetylsalicylic acidis effective on the recurrence and survival of colon cancer patients.

Detailed description: The purpose of this study is to determine the effect of 80mg acetylsalicylic acid (given orally once daily for 5 years) on 5 year overall survival (OS) for stage II and III colon cancer patients of 45 years of age and older. Preclinical, epidemiologic and clinical evidence suggest that acetylsalicylic acid use may reduce overall cancer risk and mortality in colon cancer patients. It is a phase III double blind placebo controlled, randomized trial of adjuvant low-dose acetylsalicylic acid in colon cancer patients. Patients will be stratified at randomization by centre, age (<70 and ≥70 years) chemotherapy use (any versus none) and disease stage.

Eligibility: Inclusion Criteria:
  -  Age ≥45 years
  -  Patients must have TNM stage that is one of the following: pT3-4; N0-2 and M0, or pT1-2 and N1-2 (UICC stage II and III) (in case of >1 tumour: largest tumour is stage II or III)
  -  Patients must have completed surgical resection (R0) (both laparoscopic and open surgery) within 12 weeks of randomisation
  Exclusion Criteria:
  -  Patients with rectal cancer (defined as tumour within 15 cm from the anal verge)
  -  Patients currently taking oral anti-coagulants or use of LMWH
  -  Patients currently taking acetylsalicylic acid for any reason
  -  Patients with a history of bleeding disorders or active gastric or duodenal ulcers
  -  Patients currently taking high dose systemic glucocorticoids.(≥ 30 mg predniso(lo)n)
  -  Patients with (suspected) (non-) polyposis syndrome (FAP/AFAP, MAP, Lynch syndrome)
  -  Patients with >100 polyps of the colon or a known hereditary syndrome of the colon in a first degree family member
  -  Allergy or intolerance to salicylates.
  -  Patients with a history of other malignancies in the last 5 years, except for SCC or CIN.
  -  Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: APPLICATION OF MOLECULAR TECHNIQUES FOR IMPROVING THE DIAGNOSIS AND TREATMENT OF NODULAR THYROID LESIONS.

Summary: To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System)

Detailed description: Aim of the study To determine the improvement in diagnosis of papillary carcinoma by detecting mutation V600E BRAF in retrospective cases with inconclusive cytologic diagnosis (categories III, IV and V of Bethesda System).
  Design: Retrospective observational study. Scope: The study will be peformed at the Pathology Service, from cytological samples and paraffin file post-diagnosis. Mutations are detected by pyrosequencing technique.
  Subject of study:
  Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí.
  Methodology:
  -  Identification of cases
  -  Detection of BRAF V600E mutation, initially in histological material from the surgical specimen, and if present, detection in cytological material.
  The statistical analysis will use SPSS. Univariate and bivariate analysis will be done. Results will be presented in the form of frequency tables and percentages for qualitative variables and by average, median and standard deviation for quantitative variables. Pearson chi-square or Fisher's exact test will be applied. The Student t test or the Mann-Whitney test will be performed for quantitative variables.

Eligibility: Inclusion Criteria:
  -  Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí
  Exclusion Criteria:
  -  Non available cytological or histological material

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Multiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.

Summary: The performance of multiple minor hepatectomies (MMH) instead of major hepatectomies (MH) in patients with colorectal liver metastases (CLM) is object of debate. We build a study, using the propensity score matched analysis, to compare the short- and long-term outcome of the tow groups of patients.

Detailed description: The aim of this study is to investigate the outcome of patients with colorectal liver metastases (CLM) undergoing multiple minor hepatectomies (MMH) instead of major hepatectomies (MH). Indeed, the performance of MMH versus MH in patients with CLM is object of debate. For this purpose, the databases at two independent institutions were retrospectively reviewed. To control for confounding variable distributions, a propensity score-matched analysis 1:1 was performed, and the nearest neighbor-matching method with caliper distance of 0.01 was used. Among 554 patients, 110 patients undergoing MMH and 110 undergoing MH were matched. They were similar in baseline characteristics, comorbidities, features of the primary tumors, and CLM. Primary outcomes were short- and long-term outcome.

Eligibility: Inclusion Criteria:
  -  Diagnosis of CLM
  Exclusion Criteria:
  -  Uncertain diagnosis
  -  Lost at follow-up

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Enhanced Recovery Program After Laparoscopic Colon Cancer Surgery

Summary: An enhanced recovery program has been developed to provide for colon cancer patients faster and more personalized postoperative treatment. Most of the previous studies have showed that the efficacy of the enhanced recovery program on both subjective and objective physical recovery of patients. However, such studies are rarely conducted in South Korea. The purpose of this study is to evaluate the feasibility and efficacy of a postoperative enhanced recovery program in patients who underwent laparoscopic colon cancer surgery at a tertiary hospital in Korea.


Eligibility: Inclusion Criteria:
  -  Eligibility rule of enrollment
  -  ECOG 0-2
  -  Pathologically diagnosed colon cancer
  -  Stage I-III
  -  No functional disturbance in liver, kidney, bone marrow
  -  Informed consent
  Exclusion Criteria:
  -  Emergent operation
  -  Obstructive or perforated cancer
  -  Rectosigmoid or rectal cancer
  -  Synchronous tumor
  -  Uncontrolled psychiatric or neurologic problems
  -  Severe hepatic dysfunction (GOT, GPT ≥100IU/L)
  -  Renal dysfunction (Cr ≥2mg/dl)
  -  Recent MI, CVA, nitrate medication

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

Summary: This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).
  Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.
  Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.
  Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
  -  Prior 5-FU, oxaliplatin and irinotecan
  -  ECOG Performance Status of 0 or 1
  -  Able to swallow/retain oral drugs
  -  Able and agree to have provide tumor tissue/have biopsies
  -  Agree to use contraception
  -  Not pregnant
  -  Adequate organ system function
  Exclusion Criteria:
  -  Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies <28 days or 5 half lives
  -  Prior EGFR, MEK, or RAF inhibitor or regorafenib
  -  Current use of prohibited medications
  -  Unresolved side effects
  -  GI disease or other condition affecting GI absorption
  -  Mucosal or internal bleeding
  -  Any major surgery <four weeks
  -  HIV, HBV, or HCV positive
  -  Active infection
  -  Leptomeningeal disease
  -  Brain metastases
  -  Unacceptable QTcF interval
  -  Significant uncontrolled arrhythmias
  -  Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting < 6 mos.
  -  Class II, III, or IV heart failure
  -  Other clinically significant ECGs
  -  Intra - cardiac defibrillators
  -  Cardiac metastases
  -  Condition that may interfere with patient safety
  -  Hypersensitivity to study drugs
  -  Severe or uncontrolled systemic diseases
  -  Pregnant or lactating
  -  Retinal vein occlusion
  -  Interstitial lung disease or pneumonitis
  -  Active liver or biliary disease

Relevance to patient case: not relevant
Patient case: 35-year-old male with Colon cancer. Genetic variant: BRAF (V600E). Other conditions: None.

Clinical trial: Efficacy and Safety of Oxaliplatin Combined With Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Colon Cancer Patients

Summary: The study aims to identify the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with local advanced colorectal cancer.


Eligibility: Inclusion Criteria:
  1. Performance status (ECOG) 0~2
  2. Histologically confirmed colon cancer.
  3. No prior treatment
  4. CT-defined T4 or lymph node-positive colon cancer
  5. Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL Bilirubin level ≤ 1.0 x ULN
  6. AST and ALT < 1.5 x ULN
  7. Serum creatinine ≤ 1.0 x ULN
  8. Life expectancy of ≥ 3 months
  9. Signed written informed consent
  Exclusion Criteria:
  1. Final stage with cancer cachexia
  2. Allergy for capecitabine or oxaliplatin
  3. Any evidence of extrahepatic metastases and/or primary tumor recurrence
  4. Severe organ failures or diseases, including: clinically relevant coronary disease, cardiovascular disorder or myocardial infarction within 12 months before study entry, severe psychiatric illness, severe infection and DIC

Relevance to patient case: not relevant