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

Clinical trial: Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

Summary: The purpose of this study is to determine whether MRI is more accurate than CT in determining the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI) preoperatively in colon cancer.

Detailed description: The patient will proceed with their usual colon cancer assessment and treatment, including colonoscopy with biopsy and histology and preoperative CT chest abdomen and pelvis. In addition, patients who enroll in the study will have 2 preoperative MRIs of their abdomen and pelvis performed. One of these will be performed on a 1.5T and the other will be performed on a 3.0T MRI scanner. We will use 20mg of IM buscopan to reduce bowel mobility for each scan. A coronal scout scan will be taken to identify the tumour and select the target volume. IV gadolinium (a contrast agent routinely used in MRI scans to help identify different tissues) will be administered, and a 3D VIBE scan (T1 weighted) will be performed of the target volume. The liver will also be imaged at this time to look for liver metastases. A T2 weighted 3D volume acquisition will then be obtained of the target volume containing the tumour (and its lymphatic drainage).
  The MRI will be independently reported by an expert without knowledge of the results of any other investigations. The results of the MRI scan will then be made available to the clinical team. The patient will then proceed as normal with any other investigation which the clinical team feel is necessary, and be treated as normal for their colon cancer. The patient will proceed with their surgery as normal, and the specimen removed at the time of the operation will be examined in the pathology laboratory to determine the exact stage of the cancer.
  The accuracy of CT and MRI in staging colon cancer will then be determined against the reference standard provided by the histology examination.

Eligibility: Inclusion Criteria:
  -  patients undergoing treatment for colon cancer
  -  patients undergoing primary surgery for colon cancer and who do not require neo-adjuvant therapy on the basis of their pre-operative CT
  Exclusion Criteria:
  -  age <18
  -  unable to consent
  -  consent withheld or withdrawn
  -  Unable to have an MRI (e.g pacemaker, metal implant)
  -  Allergy or contraindications to busocopam, gadolinium, small bowel contrast agent

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

Clinical trial: Cetuximab and Simvastatin in Treating Patients With Advanced or Metastatic Colorectal Cancer

Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Simvastatin may help cetuximab work better by making tumor cells more sensitive to cetuximab. Giving cetuximab together with simvastatin may kill more tumor cells.
  PURPOSE: This phase II trial is studying giving cetuximab together with simvastatin in treating patients with advanced or metastatic colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the percentage of patients with k-ras mutant, advanced or metastatic colorectal cancer who are free from progression and alive after 12.5 weeks following the first dose of cetuximab in combination with simvastatin.
  Secondary
  -  To determine the correlation between overall response rate, progression-free survival, overall survival, and safety with skin toxicity and efficacy.
  -  To determine the predictive value of PTEN, PIK3CA, b-raf, and ERK and MEK status. (exploratory)
  -  To determine the predictive value of SNPs, proteomics, and circulating DNA. (exploratory)
  -  To evaluate cholesterol, proteomics, and circulating DNA as biomarkers in this setting. (exploratory)
  OUTLINE: This is a multicenter study.
  Patients receive cetuximab IV weekly and oral simvastatin once daily on days 1-7. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity.
  Blood samples are collected for laboratory studies at baseline, during study, and after completion of study.
  After completion of study therapy, patients are followed up for 30 days.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of advanced or metastatic colorectal cancer
  -  Progressive disease in the past 3 months
  -  Failed prior oxaliplatin-, fluorouracil (5-FU)-, and irinotecan-containing regimens AND have the presence of a k-ras mutation within codon 12, 13, or 61
  PATIENT CHARACTERISTICS:
  -  WHO performance status 0-2
  -  Adequate organ function
  -  No history of toxicity during statin use
  -  No other malignancy within the past 5 years
  -  No history of severe pulmonary disease
  -  No clinically relevant coronary artery disease
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior epidermal growth factor receptor (EGFR)-targeting agents
  -  No concurrent verapamil or amiodarone

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

Clinical trial: Evaluation of Computer-assisted, Non-cathartic CT Colonography

Summary: The purpose of this study is to evaluate the performance of a non-cathartic, computer-assisted form of CT Colonography (Virtual Colonoscopy) for detection of pre-cancerous colon polyps in a group of asymptomatic screening patients.

Detailed description: Examinations to completely assess the colonic anatomy for the purposes of polyp detection and cancer prevention all require an unpleasant, pre-exam cathartic bowel preparation. The discomfort and embarrassment associated with this bowel prep has been identified as a barrier to adherence of at-risk subjects with recommended colon screening guidelines. CT Colonography (CTC) is an imaging based test that evaluates the entire colon anatomy and requires cathartic bowel prep; its performance is considered comparable to optical colonoscopy (OC) for adenomatous polyp detection. In addition, CTC generates a large amount of data to be read by a human, and this data interpretation task can be aided by computer-assisted-detection (CAD) software to identify potential polyp lesions for the human reviewer. This trial studies the performance of a form of CTC that uses fecal tagging and electronic image cleansing to obviate the need for cathartic prep. In addition, readings prospectively employ CAD to potentially buffer human interpretation performance. The investigators are prospectively testing this augmented (non-cathartic, CAD-assisted) form of CTC in asymptomatic (screening) cohort. The trial is a prospective test comparison, using segmentally unblinded optical colonoscopy in combination with pathology specimens as a reference standard for presence of target lesions, adenomatous polyps 6 mm or greater in size.

Eligibility: Inclusion Criteria:
  -  age 50-80, eligible for colon screening
  Exclusion Criteria:
  -  prior anatomic colon screening exam (optical colonoscopy, sigmoidoscopy, barium enema, CT Colonography) within last 5 years
  -  personal history of inflammatory bowel disease, polyposis syndrome, colo-rectal cancer, colon surgery
  -  documented passage of blood per rectum within last 12 months

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 and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Summary: This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.


Eligibility: Inclusion Criteria:
  -  pathologic proven colon cancer
  Exclusion Criteria:
  -  Tumor located in distal transverse colon, splenic flexure, and descending colon
  -  distant metastasis
  -  acute obstruction and/or perforation
  -  associated with FAP or HNPCC
  -  synchronous malignancy
  -  ASA score 3 or 4
  -  pregnancy
  -  no consent

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

Clinical trial: Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer

Summary: RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status.
  Secondary
  -  To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response.
  OUTLINE: This is a multicenter study.
  Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.

Eligibility: DISEASE CHARACTERISTICS:
  -  Participation in CALGB-C80405
  -  Have KRAS WT or KRAS mut tumor
  -  Randomized to treatment with either bevacizumab or cetuximab alone
  -  Patients randomized to the combination therapy are not eligible
  -  Available specimens at the PCO for BRAF mutation detection
  -  Patient consent for use of samples

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

Clinical trial: Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer

Summary: RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.
  PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
  -  To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.
  OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.
  Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.
  After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer
  -  Potentially operable disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Not specified
  -  Menopausal status not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

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

Clinical trial: Study of Everolimus and Sorafenib in Patients With Advanced Thyroid Cancer Who Progressed on Sorafenib Alone

Summary: The goal of this study is to determine the effect of combining everolimus and sorafenib in patients with metastatic differentiated thyroid cancer who progressed on sorafenib alone.

Detailed description: The purpose of this research study is to:
  1. Find out if sorafenib and everolimus prevent the growth of tumors that have grown when treated with sorafenib alone
  2. Find out how long one might benefit from treatment with sorafenib and everolimus
  3. Find out what side effects this drug may cause
  4. Measure the amount of sorafenib and everolimus in the blood and see if "markers" can be found to help understand who might benefit from sorafenib and everolimus.

Eligibility: Inclusion Criteria:
  -  Diagnosis of thyroid cancer, that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  -  All patients will have been required to have had sorafenib for entry and have had documented progression while on previous treatment with sorafenib.
  -  Measurable disease defined as at least one malignant lesion that can be accurately measured on computerized tomography (CT) and/or magnetic resonance imaging (MRI) scan.
  -  ECOG performance status < 2.
  -  Life expectancy greater than 3 months.
  -  Intellectual, emotional, and physical ability to comply with oral medication.
  Exclusion Criteria:
  -  Restrictions regarding certain prior treatments will apply.
  -  Significant medical disease including: uncontrolled congestive heart failure; active symptoms of coronary artery disease, uncontrolled seizure disorder; active infection; uncontrolled diabetes mellitus; requirement for chronic high dose corticosteroid treatment (Topical or inhaled corticosteroids are allowed); requirement for concurrent immunosuppressive drug(s); active autoimmune disease.
  -  Organ allografts.
  -  Known HIV-infection (HIV testing is not required for participation).
  -  Pregnant or breast feeding. Women of childbearing potential and sexually active males must be advised to take precautions to prevent pregnancy during treatment
  -  History of second cancer (except adequately treated basal cell or squamous cell skin cancer, in situ treated cervical cancer, colon cancer or melanoma, or any other cancer for which the patient has been disease-free for three or more years).
  -  Known hypersensitivity to everolimus or other rapamycins (e.g., sirolimus, temsirolimus) or to its excipients
  -  Use of any experimental therapy within 4 weeks prior to baseline evaluations done prior to enrollment (with the exception of sorafenib which may be continued until treatment start). Therefore, all experimental treatments other than sorafenib must be discontinued 4 weeks prior to baseline studies or enrollment.
  -  Patients who did not previously tolerate sorafenib at 200 mg once daily are excluded from the study.

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 Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma

Summary: This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E mutation-positive metastatic melanoma. Patients will be randomized to receive in a crossover design single oral doses of RO5185426 with or without food, with a 10-day washout period between doses. Following the crossover periods, patients will receive RO5185426 orally twice daily on a continuous basis until disease progression or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Histologically confirmed metastatic melanoma (Stage IV, American Joint Committee on Cancer)
  -  Positive BRAF V600E mutation result determined by Cobas 4800 BRAF V600 Mutation Test
  -  Previously treated patients must have failed at least one prior treatment regimen; if patients have received prior systemic treatments for metastatic melanoma, the time elapsed from previous therapy must be >/= 28 days; patients must have recovered fully from toxicities of all prior therapy
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Evaluable disease (measurable for disease progression according to RECIST criteria)
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  Active CNS lesions
  -  History of or known spinal cord compression or carcinomatous meningitis
  -  Anticipated or ongoing administration of anti-cancer therapies other than those administered in this study
  -  Previous malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix
  -  Previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor
  -  Refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug

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 of Single Incision (Embryonic NOTES) Laparoscopic Colorectal Surgery

Summary: Laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single incision (Embryonic NOTES) colon surgery has been attempted.
  However, there are not sufficient evidences for single incision colon surgery in colon cancer.
  The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer.

Detailed description: After several randomized clinical trials, laparoscopic colon surgery has been performed widely. As a minimal invasive approach, single Incision (Embryonic NOTES) colon surgery has been attempted. Several studies reported the feasibility of single incision colon surgery.However, there are not sufficient evidences for single incision colon surgery, especially in colon cancer.
  The investigators are researching the efficacy and safety of single incision laparoscopic sigmoidectomy in sigmoid colon cancer. Harvested numbers of lymph node will be assessed for the efficacy and postoperative morbidity and mortality will be assess for the safety.

Eligibility: Inclusion Criteria:
  -  Patients should sign a written informed consent
  -  Age between 18-80
  -  Patients have sigmoid colon cancer that was proved by pathology
  -  Adequate bone marrow function Hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) WBC ≥ 3,000/mm3 PLT ≥ 100,000/mm3
  -  Adequate kidney function Creatinine ≤ 1.5 mg/dl
  -  No remarkable evidence of heart dysfunction and lung dysfunction
  Exclusion Criteria:
  -  Distant metastasis
  -  Tumor diameter > 5 cm
  -  Other organ invasion
  -  Intestinal obstruction and stent insertion status
  -  Patient was used steroid
  -  Patients undergo emergency surgery with multiple symptoms
  -  Other organ cancer history (except who had radical excision for skin cancer)
  -  Presence of other serious disease
  -  Mentally ill patients
  -  Legally unable to participate in clinical trial
  -  Lactating or pregnant women
  -  Patients who will obviously fail to regular follow-up visit or will be off study voluntarily
  -  Not eligible to participate for other reasons by doctor's decision

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 Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Summary: This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600 mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are eligible. Participants will be assigned to different cohorts with escalating oral doses of vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage [DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until disease progression, unacceptable toxicity or any other discontinuation criterion is met.


Eligibility: Inclusion Criteria:
  -  Participants with histologically confirmed melanoma (unresectable Stage IIIc and Stage IV metastatic melanoma, as defined by American Joint Committee on Cancer [AJCC])
  -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V) 1.1
  -  Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to (</=) 1
  -  Participants must
  1. be previously untreated for locally advanced/unresectable or metastatic melanoma or
  2. previously treated but without prior exposure to any BRAF or MEK inhibitor therapy or
  3. progressed on vemurafenib while participating in a Phase I (including clinical pharmacology studies), II, or III clinical study or expanded access programs (EAP) immediately prior to enrollment in this study or
  4. progressed on vemurafenib administered in a postmarketing setting immediately prior to enrollment in this study.
  -  Life expectancy >/=12 weeks
  Exclusion Criteria:
  -  History of prior significant toxicity from another RAF or MEK pathway inhibitor requiring discontinuation of treatment
  -  Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment
  -  Experimental therapy within 4 weeks prior to first dose of study drug treatment except vemurafenib
  -  Major surgery within 4 weeks of first dose of study drug treatment or planning a major surgery during the study

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

Clinical trial: Adjuvant Colon Cancer w/ ELOXatin®/5 FU Based Regimen: ACCELOX

Summary: Adjuvant Colon Cancer With ELOXatin®/5 FU Based Regimen: ACCELOX

Detailed description: It's a study of adjuvant colon carcinoma using ELOXatin/5-FU based chemotherapeutic regimen called ACCELOX as a definitive curative therapy.

Eligibility: Inclusion Criteria:
  -  Patients with Adjuvant Colon Cancer
  Exclusion Criteria:
  -  Patients with diagnosis other than Colon Cancer.

Relevance to patient case: not relevant