araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer

Summary: The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab

Detailed description: Phase 1: Single Arm Study
  Phase 2: Randomized Controlled, Parallel

Eligibility: Inclusion Criteria:
  -  Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
  -  Histologic or cytologic confirmation of the diagnosis.
  -  Eastern Cooperative Oncology Group (ECOG) ≤ 1
  -  Adequate organ & marrow function.
  Exclusion Criteria:
  -  Uncontrolled or significant cardiovascular disease.
  -  Phase 2: Prior therapy with a RAF inhibitor.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients

Summary: Advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. It does not matter if the patients are ill or healthy. It is especially important for people who have diseases that cannot be cured. It allows people to make sure their wishes are respected if they become very sick or are dying. Thinking about these issues can be upsetting. But, for many people, it is helpful. This type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made


Eligibility: Inclusion Criteria:
  -  Primary pancreatic or hepatobiliary cancer (including ampullary carcinoma)as well as gastric and/or esophageal cancers, excluding neuroendocrine histology
  -  Progressive disease: Locally advanced or metastatic disease with progression on at least one course of treatment (surgery, radiation, or chemotherapy), or untreated patients unfit for therapy because of comorbidities or ECOG performance status >2, and finally, patients with ECOG performance status 2 -- patients must have discussed on at least one occasion with the treating investigator oncologist that their cancer cannot be cured
  -  In the estimation of the treating physician investigator, life expectancy ≤ 1 year
  -  Known to a GI medical oncology MSKCC clinic: Patients who have already established a relationship with a GI medical oncologist (who is an investigator on this protocol) after at least one new visit in the clinic (or as an in-patient), have MSKCC pathologist confirmed cancer of an above histology, and express an initial intent to be followed primarily at MSKCC
  -  English speaking*
  -  Able to provide informed consent
  -  Age greater than or equal to 18 years
  -  Do not have an advance directive or living will * English is the validated language in one of the study tools, and the language in which information is communicated in the narrative and video.
  Exclusion Criteria:
  -  Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental functioning" (3 or more errors). SPMSQ in appendix.
  -  Any patient psychological state deemed by the treating physician to pose any risk of psychological harm by issues raised in a discussion of the trial, or in its testing procedures. Any subject who may become upset during any aspect or discussion of the study will be offered counseling services.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Neoadjuvant Treatment of Colon Cancer

Summary: This study will investigate
  -  the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene
  -  the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.


Eligibility: Inclusion Criteria:
  -  Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
  -  Analysis of KRAS, BRAF, PIK3CA
  -  Age ≥18 år
  -  Performance status ≤ 2
  -  Hematology
  -  ANC ≥ 1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  -  Biochemistry
  -  Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL
  -  Consent to translational research
  -  Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
  -  Written and orally informed consent.
  Exclusion Criteria:
  -  Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease.
  -  Peripheral neuropathy NCI grade >1
  -  Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ
  -  Other investigational treatment within 30 days prior to treatment start
  -  History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
  -  Bleeding tumors
  -  Hypersensitivity to one or more of the substances

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Pemetrexed and Gemcitabine for Treatment Resistant Patients With Metastatic Colorectal Cancer and KRAS Mutations

Summary: This study aims to investigate the efficacy and safety of the combination of pemetrexed and gemcitabine in heavily pre-treated, chemotherapy resistant colorectal cancer patients with KRAS mutations.


Eligibility: Inclusion Criteria:
  -  Histologically verified adenocarcinoma in colon or rectum
  -  Age >18
  -  Metastatic colorectal cancer progressed after chemotherapy regimens containing fluoropyrimidines, oxaliplatin and irinotecan.
  -  KRAS mutation in primary tumour or metastasis.
  -  Measurable disease according to RECIST
  -  ECOG performance status 0, 1 or 2
  -  Adequate function of liver, kidneys and bone marrow measured by biochemistry (max. 2 weeks before enrolment)
  -  EDTA clearance: Uncorrected GFR > 45 ml/min.
  -  Neutrophilocytes ≥1.5 x 10^9/l, leukocytes ≥3.0 x 10^9/l, thrombocytes ≥100x10^9/l
  -  ALAT ≤ 3 x upper normal value (ULN), bilirubin ≤ 3 x upper normal value, Aptt and INR normal (or 2-3 at AC treatment). (ALAT and basic phosphatase ≤ 5 x upper normal value in case of liver metastases).
  -  Blood samples and paraffin embedded tissue from primary tumour and/or metastases for translational research.
  -  Fertile men and women (women <2 year after last menstruation) must use efficient birth control.
  -  Signed informed consent.
  Exclusion Criteria:
  -  Clinically significant other concurrent disease making the patient unfit for participation in the study according to the investigator.
  -  Other malignant disease within 5 years prior to study enrolment, except from planocellular and basal cell carcinomas in the skin or carcinoma-in-situ cervix.
  -  Other experimental treatment within 30 days prior to treatment start.
  -  Pregnant or breastfeeding women.
  -  Clinical or radiological signs of CNS metastases.
  -  Planned radiation of target lesions.
  -  Concurrent vaccination against yellow fever.

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer

Summary: In extrahepatic bile duct cancer and pancreatic cancer, we will treat postoperatively with COX2 inhibitor and assess survival rate and recurrent rate.

Detailed description: Patients : total 220 patients
  -  Extrahepatic bile duct cancer : 55 patients for administration of COX2 55 patients for control group
  -  Pancreas cancer : 55 patients for administration of COX2 55 patients for control group
  Indication
  -  After operation of extrahepatic bile duct cancer or pancreas cancer
  -  Age : 19 - 70 years old
  -  The patients who agree to consent sheet.
  Contraindication
  -  Impossible of administration due to severe postoperative morbidities (bleeding, bowel obstruction, pancreatic fistula, biliary fistula)
  -  Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP>160)
  -  Renal insufficiency: CCR < 50 or serum creatinin >3.0
  -  Hepatic insufficiency: Liver cirrhosis or active hepatitis
  -  Preexisting allergic reaction history for NSAIDs or Sulfonamide
  -  Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
  -  Preexisting Asthma. Especially aspirin-sensitive asthma.
  -  Contraindications to aspirin, clopidogrel or celecoxib
  -  The patients who refuse trial
  -  The patients who has Psychogenic problem
  Allocation
  -  We will allocate patients randomly, to administration group or control group
  Methods
  -  From postoperative third day, administration will be started
  -  celecoxib 200mg bid for 6 months for administration group
  -  Follow up and assess recurrence rate and survival rate

Eligibility: Inclusion Criteria:
  -  The patients who underwent operation for extrahepatic bile duct cancer or pancreas cancer
  -  Between 19 and 70 years old
  -  Agreed to consent sheet
  Exclusion Criteria:
  -  The patients cannot administration of drug due to severe postoperative morbidities.
  -  Preexisting heart disease: Ischemic heart disease, Heart failure. Severe uncontrolled hypertension (systolic BP>160)
  -  Renal insufficiency: CCR < 50 or serum creatinin >3.0
  -  Hepatic insufficiency: Liver cirrhosis or active hepatitis
  -  Preexisting allergic reaction history for NSAIDs or Sulfonamide
  -  Current drug intake: Warfarin. Lithium, Fluconazole, Aspirin, Celecoxib
  -  Preexisting Asthma. Especially aspirin-sensitive asthma.
  -  Contraindications to aspirin, clopidogrel or celecoxib
  -  When patients refused
  -  Patients has psychological problem

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec

Summary: The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.

Detailed description: A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer

Eligibility: Inclusion Criteria:
  - Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .
  Exclusion Criteria:
  - Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate

Summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
  -  To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.
  OUTLINE: This is a multicenter study.
  DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of refractory non-small cell lung cancer
  -  Received sorafenib tosylate on protocol ECOG-E2501
  -  Available blood specimens
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: An Observational Study to Evaluate the Safety and Efficacy of FOLFIRI / FOLFOX Plus Cetuximab as First-line Therapy in Patients With KRAS Wild-type Metastatic Colorectal Cancer

Summary: This is an open-label, non-randomized, prospective, multicentric, Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC.

Detailed description: Cetuximab, a chimeric immunoglobulin G1 (IgG1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-FU/FA and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with KRAS wild-type mCRC in the first-line setting. The purpose of this study is to generate post marketing surveillance (PMS) data for cetuximab in first-line mCRC, which is mandated by the Licensing Authorities.
  This is an open-label, non-randomized, prospective, multicentric Phase IV study evaluating FOLFIRI/ FOLFOX plus cetuximab in the first-line therapy of subjects with KRAS wild-type metastatic CRC. The study plans to enroll 100 subjects with KRAS wild type CRC at 20 centres across India. Tumour status, physical and laboratory examinations will be performed during the baseline visit. Subjects will be administered FOLFIRI/ FOLFOX and cetuximab according to the clinical condition in the following treatment visits. Regular safety assessments and all adverse events (AEs) will be documented throughout and until the end-of-study visit. The outcome of AEs ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (If possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). Skin toxicity present at the end-of-study visit will be followed up until outcome is known.
  OBJECTIVES
  Primary Objective:
  -  To evaluate the safety and tolerability of Cetuximab in combination with standard chemotherapy such as FOLFOX or FOLFIRI as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.
  Secondary Objective:
  -  To evaluate the efficacy of Cetuximab in combination with standard chemotherapy as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mCRC)
  -  Subjects with KRAS wild-type status of tumour tissue
  -  Chemotherapy naïve subjects
  -  Subject who have signed written informed consent (as per institutional protocol)
  Exclusion Criteria:
  -  As per summary of product characteristics of cetuximab

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: The Patency Period of the New Plastic Anti-reflux Biliary Stent

Summary: The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.

Detailed description: Bile duct related cancer is a condition quite commonly seen among Asians. Predisposing conditions for primary bile duct cancer include recurrent infections and autoimmune diseases such as recurrent pyogenic cholangitis (RPC) and primary sclerosing cholangitis (PSC) as well as congenital problem such as choledochal cyst. Peri-ampullary tumour, pancreatic tumour and metastatic tumours with bile duct compression are other causes of bile duct obstruction. As many of these tumours are discovered at a late stage, curative treatment is usually not feasible. Palliative endoscopic stenting of the obstructed biliary system remains the treatment of choice for the majority.
  The main problem with endoscopic stenting of the biliary system is the short stent patency period. There are some reports on modifications to plastic biliary stenting method in recent years including changes in stent designs, use of a different material or coating, administrating prophylactic antibiotics and the use of special drugs. All these have failed to show any conclusive effect on the stent patency period.
  A preliminary study has demonstrated some promising results in the use of a stent with an anti-reflux property very similar to the stents the investigators are using in this study.

Eligibility: Inclusion Criteria:
  -  Age 18 years old
  -  Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting
  -  Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression
  -  Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria.
  Exclusion Criteria:
  -  Patients fit for surgery.
  -  Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments.
  -  Previous sphincterotomy.
  -  Other medical conditions that will result in a life expectancy of less then 3 months (ASA class >4)
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: Comparison of Biliary Forceps Biopsy and Brush Cytology

Summary: Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates.
  The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.


Eligibility: Inclusion Criteria:
  -  biliary stenosis with suspected malignancy
  Exclusion Criteria:
  -  no definite diagnosis available

Relevance to patient case: not relevant
Patient case: 61-year-old male with Ampullary carcinoma. Genetic variant: KRAS. Other conditions: None.

Clinical trial: KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009

Summary: -  There is no data at present concerning the KRAS mutation in patients from Martinique with colorectal cancer. Despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. This study has a descriptive purpose, allowing a comparison of the population from Martinique to other populations.
  -  A study of incidence of colorectal cancer, overseen by the Association from Martinique for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of the local characteristics of the colorectal cancer.
  -  These two descriptive characteristics of colorectal cancer in Martinique will be useful data for the health professionals to provide their patients better care.

Detailed description: -  The colorectal carcinogenesis is complex. It influences among others, the EGFR (Epidermal Growth Factor Receptor) which activation leads to tumoral proliferation, differentiation and invasion. The binding of the EGF (Epidermal Growth Factor) or of another ligand to the EGFR is responsible for the activation of the Ras- Raf and Pi3k pathways.
  -  The mutation of the genes KRAS, BRAF or PIK3CA results in their continuous activation, independently of the activation or of the pharmacological blocking of EGFR. The most frequently found mutation affects the KRAS gene (20 to 50 % of the cases). 90 % of these mutations are situated on codons 12 and 13 of this gene (70 % codon 12 and 30 % codon 13). These mutations are responsible for a decrease of the GTPase activity of the ras protein, which stays then in active conformation bound to the GTP. This leads to the blocking of the pathway and to the inactivity of the pharmacological blocking of EGFR.

Eligibility: Inclusion Criteria:
  -  for the study of the KRAS mutation: 250 patients drawn by lots among the cases of colorectal carcinoma diagnosed between January 1st, 2007 and December 31st, 2009 in Martinique
  -  for the study of incidence: patient for whom was diagnosed a colorectal carcinoma between January 1st, 2007 and December 31st, 2009
  -  patient unopposed and in free agreement to participate in this study
  -  patient having his main home in Martinique at the time of the diagnosis
  -  patient 18 years old and over
  Exclusion Criteria:
  -  patient whose diagnosis is prior to 2007 and later in 2009
  -  patient having shown opposition to the participation in this study
  -  patient minor or under guardianship
  -  patient not having his main home in Martinique at the time of the diagnosis

Relevance to patient case: not relevant