araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Summary: The primary objective of this study is to estimate the treatment effect on progression-free survival (PFS) of panitumumab relative to bevacizumab in combination with mFOLFOX6 chemotherapy as first-line therapy in patients with tumors expressing wild-type KRAS, unresectable mCRC.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in patients with unresectable metastatic (M1) disease
  -  Patients with at least 1 uni-dimensionally measurable lesion of at least 10 mm per modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
  -  Wild-type KRAS tumor status confirmed by an Amgen approved central laboratory or an experienced laboratory (local laboratory) per local regulatory guidelines using a validated test method
  -  Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  -  Men or women 18 years of age or older
  -  Adequate hematologic, renal, hepatic, metabolic, and coagulation function
  Exclusion Criteria:
  -  History of prior or concurrent central nervous system (CNS) metastases
  -  Prior chemotherapy or other systemic anticancer therapy for treatment of metastatic colorectal carcinoma
  -  Clinically significant cardiac disease
  -  Clinically significant peripheral sensory neuropathy
  -  Active inflammatory bowel disease
  -  Recent gastroduodenal ulcer to be active or uncontrolled
  -  History of interstitial lung disease
  -  Recent pulmonary embolism, deep vein thrombosis, or other significant venous event
  -  Pre-existing bleeding diathesis and/or coagulopathy with exception of well-controlled anticoagulation therapy
  -  Recent major surgical procedure, open biopsy, or significant traumatic injury not yet recovered from prior major surgery.

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Swiss Prospective, Multicenter Study Sentinel Lymph Node Procedure in Colon Cancer

Summary: The study is a feasibility and validation study of the sentinel lymph node (SLN) procedure in all stages of colon cancer. If the SLN can be reliably identified, it could be submitted to a more accurate histopathological examination (multiple sections, special staining). The detection of micrometastases in the SLN (occult stage III, upstaging) is possible. Patients with micrometastases should be considered at higher risk.
  Additionally, a search for occult metastatic tumor cells in the bone marrow is performed.


Eligibility: Inclusion Criteria:
  -  Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology.
  -  Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded).
  -  Patient's informed consent
  Exclusion Criteria:
  -  Prior intrabdominal tumor surgery
  -  Other preexisting malignancies
  -  Hypersensitivity/allergy to dye (isosulfan blue)
  -  Pregnancy
  -  Breast-feeding
  -  No patient's informed consent

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

Summary: This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.


Eligibility: Inclusion Criteria:
  -  metastatic colorectal cancer
  -  tumor with k-ras mutation
  Exclusion Criteria:
  -  More than 1 prior regimen for treatment of metastatic disease

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

Summary: In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.


Eligibility: Inclusion Criteria:
  -  Stage 1 and 2 hypertension without treatment for at least 2 weeks
  -  Women with no risk of becoming pregnant
  Exclusion Criteria:
  -  Study participation could result in risk to health of subject
  -  Cardiovascular disease
  -  Secondary hypertension or stage 3 hypertension
  -  Myocardial infarction within the last 6 months
  -  Congestive heart failure
  -  Pulmonary edema
  -  Valvular alterations or rheumatic cardiopathy
  -  Clinically relevant conduction disorders significant arrhythmias
  -  Alcohol or illicit drug use
  -  Medication abuse
  -  Pregnant or nursing women

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Gene Expression Profiling in Normal Tissue and Tumor Tissue From Patients With Colon Cancer That Has Spread to the Liver, Lungs, or Peritoneum

Summary: RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer may help doctors identify biomarkers related to cancer.
  PURPOSE: This laboratory study is using gene expression profiling to evaluate normal tissue and tumor tissue from patients with colon cancer that has spread to the liver, lungs, or peritoneum.

Detailed description: OBJECTIVES:
  -  Evaluate gene expression profiles in normal and tumor tissue from patients with colon cancer metastatic to the liver, lungs, or peritoneum.
  -  Establish cell lines from primary colon tumors metastatic to the liver, lungs, or peritoneum.
  -  Determine the specific gene expression changes that result in the manifestation of the drug-resistant phenotype for each metastatic site.
  OUTLINE: This is a pilot study.
  Tumor and normal tissue collected during surgery are analyzed for gene expression profiling by cDNA microarray. Tissue is also analyzed for thymidylate synthase (TS) gene expression by quantitative PCR and for protein expression by western blot. Gene expression patterns are correlated with TS levels.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer metastatic to the liver, lungs, or peritoneum
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study of Circulating Cancer Cells in Patients With Metastatic Breast, Ovarian, Colon, or Pancreatic Cancer

Summary: RATIONALE: Counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread.
  PURPOSE: This research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

Detailed description: OBJECTIVES:
  -  To assess frequency of circulating tumor cells (CTCs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers.
  -  To assess the variability in number of CTCs between patients with the same tumor type.
  -  To correlate the number of CTCs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers.
  OUTLINE: Blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. Samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., EGFR, phosphorylated EGFR, AKT, phosphorylated AKT, cytokeratins, MAPK, Src, and FAK).

Eligibility: DISEASE CHARACTERISTICS:
  -  Radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease
  -  Hormone receptor status not specified
  PATIENT CHARACTERISTICS:
  -  Menopausal status not specified
  -  No history of any prior cancer
  PRIOR CONCURRENT THERAPY:
  -  No prior therapy for metastatic disease

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Immune Response in Peripheral Blood of Patients With Colon Cancer

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells.
  PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

Detailed description: OBJECTIVES:
  -  Quantify T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) from the peripheral blood of patients with colon cancer.
  OUTLINE: This is an open-label study.
  Patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). Blood is analyzed for tumor peptides (carcinoembryonic antigen and MUC1), circulating cytokines, and lymphocyte response by ELISA, ELISPOT, or intracellular flow.
  PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of colon cancer
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study of Tumor Samples From Patients With Stage III Colon Cancer Who Have Undergone Surgery and Chemotherapy

Summary: RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer who have undergone surgery and chemotherapy may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is looking at tumor samples from patients with stage III colon cancer who have undergone surgery and chemotherapy.

Detailed description: OBJECTIVES:
  -  Identify predictive factors of efficacy and safety of adjuvant chemotherapy comprising fluorouracil-based regimens in patients with stage III colon cancer.
  -  Investigate possibility of "personalized treatment" with adjuvant chemotherapy based on the predictive factors identified.
  OUTLINE: Patients' tumor tissue samples are collected for protein expression levels of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), VEGF, EGFR, mRNA-expression levels of TP, DPD, thymidylate synthase (TS), and orotate phosphoribosyl transferase (OPRT) by ELISA, Human Duo Set, and RT-PCR assays.
  Patients' enzyme expression levels are compared with their clinical data.

Eligibility: <Inclusion criteria>
  -  Pathologically confirmed stage III colon adenocarcinoma
  -  Curatively resected (R0)
  -  Patients scheduled for treatment with fluorouracil-based post-operative adjuvant chemotherapy
  -  Provided written informed consent
  <Exclusion criteria>
  -  Synchronous or metachronous multiple cancers
  -  Contraindications for fluorouracil-based chemotherapy
  -  Patients who have initiated neo-adjuvant chemotherapy or radiotherapy prior to participating in this study
  -  Ineligible patients according to the investigator's judgement

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Vitamin K-absorption From Dairy

Summary: Lactic acid bacteria produce a mixture of higher menaquinones, including menaquinone-9 (MK-9) and menaquinone-10 (MK-10). Vitamin K1 (phylloquinone) is normally present in chloroplasts in green vegetables. A new dairy product is developed containing both vitamin K1 and K2-vitamins. However, the extent to which the various forms of vitamin K are absorbed from such a mixture is not known. In this study the absorption profile of phylloquinone and menaquinones from this new dairy product containing several K-vitamins is investigated. This study describes a dietary intervention experiment for one single cocktail containing several K-vitamins as part of a dairy product.


Eligibility: Inclusion Criteria:
  -  Healthy men and women between 20 and 45 years old
  -  Subjects of normal body weight and height according to BMI < 30
  -  Subjects of Caucasian race
  -  Subject has given written consent to take part in the study
  Exclusion Criteria:
  -  Subjects with (a history of) metabolic or gastrointestinal disease
  -  Subjects presenting chronic degenerative and/or inflammatory disease
  -  Abuse of drugs and/or alcohol
  -  Subjects receiving corticoid treatment
  -  Subjects using oral anticoagulants

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Inflammatory Response in Laparoscopic and Open Colectomy

Summary: This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery


Eligibility: Inclusion Criteria:
  -  colorectal cancer
  Exclusion Criteria:
  -  metastases
  -  stage 4 colorectal cancer
  -  recurrent disease
  -  chronic diseases
  -  obvious inflammatory condition

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study of Capecitabine and Cetuximab as First-Line Therapy in Patients With Metastatic Wild Type Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Colorectal Cancer

Summary: The combination of capecitabine and cetuximab as first-line therapy will result in improved progression free survival compared to single agent capecitabine in patients with KRAS wild type colorectal cancer. Patients who are not able or willing to take Oxaliplatin/Irinotecan combination therapy are eligible for this study.


Eligibility: Inclusion Criteria
  -  Metastatic colorectal cancer
  -  Tumor classified WT KRAS
  -  At least 18 yrs of age
  -  ECOG PS 0,1 or 2
  -  Evidence of adequate organ function
  -  Measurable disease per RECIST criteria
  -  Have at least two of the following criteria:
  -  Age > 65 years
  -  ECOG PS 1 or 2
  -  Serum Albumin < or equal to 3.5g/dL
  -  Prior RT to abdomen or pelvis
  -  Stopped first-line combination systemic chemotherapy < 6 weeks duration
  Exclusion Criteria
  -  Tumors classified as KRAS mutation
  -  Prior therapy with cetuximab, panitumumab or other agent that targets EGFR
  -  Prior exposure to any biologic
  -  Known sensitivity to cetuximab or 5-FU (or marked intolerance to 5-FU)
  -  Known DPD deficiency
  -  Uncontrolled angina or a myocardial infarction within the previous 12 months
  -  Concurrent severe uncontrolled medical illness
  -  Known uncontrolled CNS metastases
  -  Bowel disease associated with chronic diarrhea
  -  Major surgery within 28 days

Relevance to patient case: possibly relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Colon Cancer Prognosis After Radical Surgery

Summary: 1. Radical surgery. It is supposed to improve prognosis of colon cancer. A surrogate measure of achievement of radical surgery is the number of lymph nodes removed with the specimen.
  2. Markers. There may be variables that may make patient assessment more sound. The project is including investigation of such markers (genes, old age, comorbidity, and others).
  3. Laparoscopic resections. This is being used more and more in cancer surgery but the feasibility of this approach remains to be proven compared with conventional open surgery. The project compares these according to 1) and 2).
  4. Morbidity and mortality must be surveilled to keep at a minimum. Many patients have comorbidity and are old to make this factor extra important, including perioperative care.
  5. Proper treatment of colon metastases may prolong life. Treatment of lung-metastases will be studied in particular.

Detailed description: 1. Radical surgery. A detailed description of procedures for each location of tumor in the large intestine is used. By following a given procedure for each location in the large intestine, the number of lymph nodes can be analyzed for each location to find out if this differs and if prognosis is affected by lymph node numbers according to tumor site.
  2. Markers. Different variables are examined for use in clinical judgment to make treatment better as well as genetic experimental analyses for comparison with clinical outcome to better understanding of clinical behavior.
  3. Laparoscopic resections. The technical challenge of laparoscopic approach has been compared with conventional surgery without any difference being observed in trials. However, it should be compared with radical open surgery to compare best achievements by using number of lymph nodes as well as outcome measures in the short and long term (mortality).
  4. Comorbidity, old age itself, type of surgery and perioperative care according to the so called fast track surgery may all play a part in reducing perioperative morbidity and mortality. A maximum 3% mortality should be aimed for.
  5. Colon cancer usually metastasize to the liver and lungs. Surgical treatment of liver metastases has been extensively studied and the prognosis has improved. Lung metastases has not been given similar attention but the prognosis of those operated may be good and equal that after liver surgery. The need for pulmonary resection and factors associated with metastases and lung metastases in particular will be studied.

Eligibility: Inclusion Criteria:
  -  Malignant tumor (adenocarcinoma) of the large intestine (colon)
  -  Willingness to participate
  Exclusion Criteria:
  -  No radical resection (R0) possible
  -  Unwilling to participate or medically unfit to undergo follow-up

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial

Summary: The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.


Eligibility: Inclusion Criteria:
  -  primary cancer
  -  right-side located tumor (from cecum to proximal transverse colon)
  Exclusion Criteria:
  -  tumor with obstruction
  -  tumor with perforation
  -  clinically advanced tumor (T4 stage)
  -  tumor with distant metastases
  -  synchronous tumor

Relevance to patient case: not relevant
Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Study of Perifosine + Capecitabine for Colon Cancer Patients

Summary: This is a Phase I study of Perifosine + Capecitabine for patients with advanced colon cancer.

Detailed description: This study is a Phase I trial. A total of 3 ‐ 9 patients will be enrolled. Three patients will initially be enrolled. There will be no dose escalation in this study as only one dose for perifosine (50 mg) in combination with one dose of capecitabine (1000 mg/m2 BID) will be evaluated. The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced DLT attributable to the study drug(s), when at least six patients have been treated at that dose and are evaluable for toxicity. Pharmacokinetic (PK) data will also be evaluated from all enrolled patients.

Eligibility: Inclusion Criteria:
  -  Patients with 3rd line or > metastatic colon cancer
  -  Patients must have received or not be candidates for regimens containing 5‐ FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab
  -  No prior exposure to perifosine
  -  Adequate bone marrow, liver, and renal function
  -  Patients must have at least one measurable lesion
  -  Patients must agree to have extra blood drawn for PK analyses
  Exclusion Criteria:
  -  Patients with prior exposure to perifosine.
  -  Patients receiving any other investigational agents or devices.
  -  History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
  -  Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5‐FU.
  -  Patients with known central nervous system CNS metastases.
  -  Patients with known HIV, Hepatitis B, or Hepatitis C seropositivity.
  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and psychiatric illness/social situations that would limit compliance with study requirements.
  -  Patients with a history of unstable or newly diagnosed angina pectoris, recent myocardial infarction (within 6 months of enrollment), or New York Heart Association class II‐IV congestive heart failure.
  -  Female patients who are pregnant or lactating are ineligible.

Relevance to patient case: not relevant