araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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: definitely relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

Summary: This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene


Eligibility: Inclusion Criteria:
  -  Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant)
  -  Availability of a representative formalin fixed paraffin embedded tumor tissue sample
  -  At least one measurable or non-measurable lesion
  -  Age ≥ 18 years
  -  World Health Organization (WHO) Performance Status ≤ 2
  -  Good organ (hepatic, kidney, BM) function at screening/baseline visit
  Exclusion Criteria:
  -  Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed).
  -  Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit
  -  Patient with peripheral neuropathy NCI-CTC Grade ≥ 3
  -  Patient with diarrhea NCI-CTC Grade ≥ 2
  -  Patient with acute or chronic pancreatitis
  -  Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
  -  Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus
  -  Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

Summary: This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

Detailed description: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies.

Eligibility: Inclusion Criteria:
  -  Aged at least 18 years.
  -  Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
  -  ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F).
  -  The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.
  -  Estimated life expectancy of more than 12 weeks.
  Exclusion Criteria:
  -  Clinically significant abnormalities of glucose metabolism.
  -  Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
  -  Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  -  Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
  -  A bad reaction to AZD5363 or any drugs similar to it in structure or class.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Implementation of Laparoscopy-assisted Surgery for Colon Cancer

Summary: The purpose of this study is to study the implementation of laparoscopy-assisted surgery for cure of colon cancer in daily surgical practice.

Detailed description: Prospective observational study of laparoscopy-assisted surgery for resectable colon cancer with regard to short term and long term outcomes

Eligibility: Inclusion Criteria:
  -  Age >17 years
  -  diagnosis of colon cancer either endoscopically, radiologically or histologically proven
  -  No evidence of disseminated disease on CT scan
  -  T1-3 according to preoperative CT scan
  -  written informed consent to participate
  Exclusion Criteria:
  -  preoperative diagnosis of locally advanced tumor (T4)
  -  suspicion of pathological lymph nodes outside anticipated resection area
  -  contraindications against laparoscopic surgery, e.g. known bowel adhesions, anesthesiological concerns
  -  lack of informed consent

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 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 RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant 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 BEZ235 and MEK162.
  Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, 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 1.0
  Exclusion Criteria:
  -  Patients with primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus - Unacceptable ocular/retinal conditions
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Biomarkers in Tissue Samples From Older Women With Breast Cancer

Summary: This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:
  To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer.
  OUTLINE:
  Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.

Eligibility: -  Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown
  -  Patients underwent lumpectomy with negative margins and were clinically node-negative

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Attenuated Inflammatory Response in Laparoscopic Colon Surgery

Summary: Pro-inflammatory responses following laparoscopic surgery.

Detailed description: Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.

Eligibility: Inclusion Criteria:Colon cancer stage I-III -
  Exclusion Criteria:Colon cancer stage IV
  -

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Summary: This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.


Eligibility: Inclusion Criteria:
  -  Histologically/cytologically confirmed, advanced solid tumors, AML or high risk and very high risk MDS
  -  Measurable disease as determined by RECIST 1.1
  Exclusion Criteria:
  -  Primary CNS tumor or CNS tumor involvement
  -  Diabetes mellitus
  -  Unacceptable ocular/retinal conditions
  -  Clinically significant cardiac disease or impaired cardiac function

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Biomarkers in Patients With Head and Neck Cancer

Summary: RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.
  PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.
  -  To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.
  OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Eligibility: DISEASE CHARACTERISTICS:
  -  Treated on protocol ECOG-E5397
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

Clinical trial: Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Summary: Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.
  The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Eligibility: Inclusion Criteria:
  -  The patients diagnosed as biliary tact adenocarcinoma.

Relevance to patient case: not relevant