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: Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor Patients

Summary: This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of the orally administered phosphatidylinositol 3'-kinase (PI3K) inhibitor BKM120 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BKM120 and MEK162.
  Study drugs will be administered once daily orally on a continuous schedule. A treatment cycle is defined as 28 days.


Eligibility: Inclusion Criteria:
  -  Histologically/ cytologically confirmed, advanced non resectable solid tumors
  -  Measurable or non-measurable, but evaluable disease as determined by RECIST
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement.
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions

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: Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer

Summary: The purpose of this study is to evaluate the benefit of panitumumab in addition to best supportive care compared to best supportive care alone in patients with chemorefractory wild-type KRAS (Kirsten rat sarcoma viral oncogene homolog) metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Diagnosis of metastatic colorectal cancer (CRC)
  -  Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  -  At least 1 measurable or non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
  -  Treatment failure (defined as failure due to either disease progression [clinical or radiological] or toxicity [treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease. Oxaliplatin and irinotecan may have been administered sequentially or in combination.
  -  Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen) will also be considered as treatment failure of a prior regimen for metastatic disease
  -  Must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of CRC
  -  Man or woman at least 18 years of age
  -  Adequate hematologic, renal, hepatic and metabolic function
  -  Negative pregnancy test within 72 hours before randomization (for women of childbearing potential only)
  -  Subject or subject's legally acceptable representative has provided informed consent.
  -  Other protocol-specified criteria may apply
  Exclusion Criteria:
  -  Symptomatic brain metastases requiring treatment
  -  History of another primary cancer within 5 years of randomization
  -  Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib)
  -  Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) within 21 days before randomization
  -  Radiotherapy within 14 days before randomization.
  -  Exclusion Criteria for corrected QT (QTc) Evaluation Subpart of the Study: Prolongation of QT/QTc interval > 450 milliseconds at screening
  -  Other protocol-specified criteria may apply

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: BRAF V600E Mutations In Papillary Thyroid Carcinoma

Summary: The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

Detailed description: Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

Eligibility: Inclusion Criteria:
  -  Patients with papillary thyroid cancer
  Exclusion Criteria:
  -  Patients who do not want to be a part of this study

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: Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Summary: This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H&E and unstained slides to specific biomarker results using immunohistochemistry.

Detailed description: This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Eligibility: Inclusion Criteria:
  -  Patient with palpable thyroid nodule suspicious for thyroid neoplasm
  -  Patient selected to undergo fine needle biopsy for cytologic diagnosis
  -  Male (18 years of age or older)
  -  Female (18 years of age or older)

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: First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer

Summary: The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients


Eligibility: Inclusion Criteria:
  -  Histologically confirmed colorectal adenocarcinoma;
  -  Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
  -  BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
  -  Unresectable and measurable metastatic disease according to RECIST criteria;
  -  Male or female, aged > 18 years and < 75 years;
  -  ECOG PS < 2 if aged < 71 years;
  -  ECOG PS = 0 if aged 71-75 years;
  -  Life expectancy of more than 3 months;
  -  Adequate haematological function: ANC ≥ 1.5 x 10^9/L; platelets ≥ 100 x 10^9/L, Hb ≥ 9 g/dL;
  -  Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN);
  -  Serum creatinine ≤ 1.5 x ULN;
  -  Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
  -  At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
  -  Written informed consent to experimental treatment and molecular analyses.
  Exclusion Criteria:
  -  Presence or history of CNS metastasis;
  -  Serious, non-healing wound, ulcer, or bone fracture;
  -  Evidence of bleeding diathesis or coagulopathy;
  -  Uncontrolled hypertension;
  -  Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
  -  Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes;
  -  Chronic, daily treatment with high-dose aspirin (>325 mg/day);
  -  Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
  -  Active uncontrolled infections;
  -  Treatment with any investigational drug within 30 days prior to enrolment;
  -  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ cancer of the cervix;
  -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
  -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
  -  Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.

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

Clinical trial: An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

Summary: This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.


Eligibility: Inclusion Criteria:
  -  Adult participants, >/= 18 years of age
  -  Treatment in line with the currently approved indication in the Summary of Product Characteristics
  Exclusion Criteria:
  -  Contraindications according to the current Summary of Product Characteristics

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: Genetic Analysis to Evaluate the Racial Difference in the Outcome of Patients With Colon Cancer

Summary: This is a retrospective genetic analysis of stored tumor tissue samples to evaluate the distribution of Recurrence Score® and gene groups of stage II colon cancer in African American (AA) and Caucasian individuals. Other covariant factors in the medical chart will be analyzed as well. Three institutions will contribute patients to this study with a total patient number goal of approximately 200 with approximately 100 being AA and approximately 100 being Caucasian. As enrollment in this study proceeds a Caucasian subject will be matched for every African American enrolled.


Eligibility: Inclusion Criteria:
  -  Subjects must be 18 years of age or older.
  -  Subjects must be AA or Caucasian.
  -  Subjects with pathologic stage II colon cancer; Irrespective of number of nodes examined.
  Exclusion Criteria:
  -  Patients of races other than AA or Caucasian.
  -  No tumor block available from initial diagnosis.
  -  No tumor or very little tumor (<5% tumor present) in block as assessed by examination of the H&E slide by the Genomic Health, Inc (GHI) - designated pathologist.
  -  Tumor types other than adenocarcinoma NOS (not otherwise specified) and mucinous carcinoma as assessed by examination of the H&E slide by the GHI-designated pathologist.
  -  Insufficient RNA (<5 ng/μL or 300 ng) for RT-PCR (radiation therapy - pathologic complete response) analysis.
  -  Failure of assay to meet pre-specified quality control (QC) specifications.

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: Multicenter Single-port Colectomy RCT

Summary: This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.
  The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

Detailed description: This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Eligibility: Inclusion Criteria:
  -  colon adenocarcinoma
  -  curative resection
  -  age : 20 ~ 85
  Exclusion Criteria:
  -  distal transverse colon cancer
  -  splenic flexure colon cancer
  -  descending colon cancer
  -  emergency operation
  -  obstruction
  -  perforation
  -  ASA 3 or 4
  -  pregnant woman
  -  tumor associated with FAP, HNPCC, or IBD
  -  distant metastasis
  -  adjacent organ invasion
  -  synchronous colorectal cancer
  -  other malignancy within last five years

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: PeerScope B System™ Clinical Protocol

Summary: The PeerScope B System™ by PeerMedical Ltd. is intended to provide visualization (via a video monitor) and therapeutic access to the lower intestinal tract. The lower intestinal tract includes, but is not restricted to the organs, tissues and subsystems: large bowel and cecum. The device is introduced rectally, as with any standard colonoscope when indications consistent with the need for the procedure are observed in the adult patient population.
  The purpose of this prospective clinical study is to establish the usability of the PeerScope B System™ when used during standard colonoscopy procedure.
  The study population is comprised of patients indicated for colonoscopy.
  The primary endpoint is reaching the cecum of the colon with PeerScope B System™.Secondary endpoints:
  1. The first secondary endpoint is the incidence of complications using the PeerMedical colonoscope.
  2. The second secondary endpoint is successful therapeutic interventions as biopsies, polypectomies, APC etc.
  3. The third secondary endpoint is the procedure time.
  4. The fourth secondary endpoint is the subjective evaluation of the additional view angle by the physician.
  5. The fifth secondary endpoint is patient satisfactory.

Detailed description: Founded in 2009, PeerMedical develops colonoscopes capable of wide view angle at the press of the button. The PeerScope B System™ is an endoscopic platform that enables the physician to get a wide angle view while maintaining all of the features commonly used during Gastrointestinal (GI) procedures with very limited learning curve and in service process. The current standard devices have viewing limitations. By adding this viewing functionality, PeerMedical will potentially empower physicians to improve polyps detection and cancers within the colon.

Eligibility: Inclusion Criteria:
  -  Subject between the ages of 18 and 70
  -  The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
  -  Written informed consent must be available before enrollment in the trial
  -  For women with childbearing potential, adequate contraception
  Exclusion Criteria:
  -  Patients with a history of colonic resection;
  -  Patients with inflammatory bowel disease;
  -  Patients with a personal history of polyposis syndrome;
  -  Patients with suspected chronic stricture potentially precluding complete colonoscopy;
  -  Patients with diverticulitis or toxic megacolon;
  -  Patients with a history of radiation therapy to abdomen or pelvis;
  -  Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.

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 Cetuximab to Treat KRAS Wild Type Metastatic Colorectal Cancer

Summary: The primary purpose of this study is to evaluate the clinical response and safety of cetuximab plus irinotecan synchronously/subsequently in patients with KRAS wild-type metastatic colorectal cancer

Detailed description: CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It is a biosimilar of cetuximab (C225, Erbitux®) and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding cetuximab (CMAB009) to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility: Inclusion Criteria:
  -  histologically confirmed metastatic colorectal adenocarcinoma
  -  KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
  -  has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
  -  ECOG performance status 0 to 1
  -  Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve
  Exclusion Criteria:
  -  Previous irinotecan or anti-EGFR therapies
  -  hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
  -  liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
  -  Renal function: serum creatinine, more than 1.5 times the upper limit of normal
  -  Patients with symptomatic central nervous system metastases

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: A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors

Summary: This is a multi-center, open-label, phase Ib/II study. First, the aim of the phase Ib part is to estimate the MTD(s) and/or to identify the recommended phase II dose(s) (RP2D) for the combination of MEK162 and AMG 479 (ganitumab), followed by the phase II part to assess the clinical efficacy and to further assess the safety of the combination in selected patient populations. The dose escalation part of the study will be guided by a Bayesian Logistic Regression Model (BLRM). At least 18 patients are expected to be enrolled in the dose escalation part.
  Following MTD/ RP2D declaration, patients will be enrolled in three phase II arms to assess efficacy of the combination as well as to better understand the safety, tolerability, PK, antibody concentrations and PD of the combination at MTD/RP2D. Phase II arm 1 will consist of approximately 25 patients with KRAS-mutant colorectal adenocarcinoma. Phase II arm 2 will consist of approximately 20 patients with metastatic pancreatic adenocarcinoma. Phase II arm 3 will consist of approximately 28 patients with mutant BRAFV600 melanoma.
  Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. All patients will be followed up - at minimum patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment.


Eligibility: Inclusion Criteria:
  -  Patients aged ≥ 18 years
  -  Patients with advanced solid tumors (CRC, melanoma) with documented somatic KRAS or BRAFV600 mutations in tumor tissue. Patients with metastatic pancreatic adenocarcinoma may be enrolled irrespectively of KRAS or BRAFV600 mutational status.
  -  Patients must have relapsed or progressed following standard therapy or patients for whom no standard anticancer therapy exists.
  -  Measurable disease as determined by RECIST v1.1. World Health Organization (WHO) Performance Status (PS) ≤ 2.
  -  Adequate organ function
  -  Negative serum pregnancy test
  Exclusion Criteria:
  -  Prior therapy with MEK- or IGF-1R- inhibitor
  -  History or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or retinal degenerative disease
  -  Patients with known history of severe infusion reactions to monoclonal antibodies
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  History of thromboembolic event requiring full-dose anticoagulation therapy
  -  Clinically significant cardiac disease
  -  History of another malignancy within 2 years
  -  Pregnant or nursing (lactating) women
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant