araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer

Summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene amplification.

Detailed description: A Randomised Open-Label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 monotherapy versus paclitaxel in Patients with Advanced Gastric or Gastro-oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (SHINE study). Patients were to be assigned to strata by FGFR2 status of: polysomy, low or high gene amplification.

Eligibility: Inclusion Criteria:
  -  Female or male aged 25 or over
  -  Histological diagnosis of locally advanced or metastatic gastro adenocarcinoma (including adenocarcinoma of the lower third of the oesophagus or the gastro oesophageal junction )
  -  Radiographically confirmed progression after 1 prior chemotherapy or chemoradiotherapy for gastric cancer. Suitable for and expected to benefit from paclitaxel monotherapy.
  -  At least one lesion, not previously irradiated, that has baseline at least 10mm in the longest diameter for non nodal lesions and is assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI)
  -  Provision of either an archival tumour sample or a fresh tumour sample for confirmation of FGFR2 polysomy/gene amplification
  Exclusion Criteria:
  -  Prior exposure to AZD4547 or history of hypersensitivity other drugs similar in structure or class to AZD4547. Hypersensitivity to paclitaxel or formulated in cremophor EL (polyoxyethylated castor oil)
  -  Prior taxane treatment for gastric cancer with the exception of adjuvant/neo-adjuvant therapy given > 6 months; Major surgery, radiotherapy with wide field of radiation or any cancer treatment within 4 weeks before the first dose of the study treatment
  -  With the exception of alopecia, any unresolved toxicities from prior therapy with a Common Terminology Criteria for AE (CTCAE) grade >1 at the time of starting study treatment.
  -  Blood and Echocardiogram (ECG) readings that are deemed to be abnormal by falling outside of the reference ranges in the protocol inclusion/exclusion section.
  -  Taking other regular medication that are predicted to interact with AZD4547 due to their route of metabolism.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

Summary: Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.

Detailed description: Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery

Eligibility: Inclusion Criteria:
  -  Patients with colorectal cancer
  -  Controls
  Exclusion Criteria:
  -  ASA>3
  -  Metastatic Disease
  -  Acute bowel obstruction
  -  Acute bowel perforation
  -  BMI<30
  -  Chronic Systemic or Autoimmune Diseases
  -  Smokers
  -  Alcohol consumers

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study of ABT-700 in Subjects With Advanced Solid Tumors

Summary: This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.


Eligibility: Inclusion Criteria:
  -  Subject with advanced solid tumors; Dose-expansion: evidence for MET gene amplification.
  -  Subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists.
  -  Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
  -  Subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: Subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib in combination with ABT-700.
  Exclusion Criteria:
  -  Subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABT-700.
  -  Subjects with uncontrolled metastases of the central nervous system. Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of ABT-700.
  -  Subject has unresolved adverse events > Grade 1 from prior anticancer therapy except for alopecia or anemia.
  -  Subject has had major surgery within 21 days prior to the first dose of ABT-700.
  -  Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or FOLFIRI/cetuximab or erlotinib per most current prescribing information, or at the discretion of the Investigator. Subjects with K-Ras mutation-positive colorectal cancer will be excluded from receiving FOLFIRI/cetuximab.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Phase II Study of Gemcitabine and Capecitabine for Treatment Resistant, Metastatic Colorectal Cancer

Summary: The present study aims to investigate the efficacy and safety of the combination of capecitabine and gemcitabine in heavily pre-treated, treatment resistant metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically verified colorectal adenocarcinomas
  -  Age > 18 years
  -  Metastatic colorectal cancer refractory to 5-FU, oxaliplatin, irinotecan and relevant biological agents.
  -  Measurable disease according to RECIST 1.1
  -  ECOG performance status 0, 1 or 2
  -  Adequate renal, hepatic and haematological function
  -  Consent to blood samples and available paraffin embedded tumour material for translational research studies
  -  Fertile males and females (<2 years after last period for women) must use effective birth control.
  -  Signed Informed consent
  Exclusion Criteria:
  -  Clinically significant concurrent disease.
  -  Other malignant diseases within 5 years of inclusion in the study, except squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
  -  Other experimental therapy within 30 days of treatment initiation.
  -  Patients who are breast feeding, childbearing or of childbearing potential without using dual effective contraception.
  -  Clinical or radiological evidence of CNS metastasis.
  -  Planned radiation therapy against target-lesions.
  -  Known allergy to 5FU/capecitabine or gemcitabine.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Efficacy and Safety of Simtuzumab With FOLFIRI as Second Line Treatment in Colorectal Adenocarcinoma

Summary: This randomized study compares the efficacy of simtuzumab (GS-6624) versus placebo in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) chemotherapy regimen in participants with metastatic KRAS mutant colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Metastatic Colorectal Carcinoma with KRAS mutation.
  -  Received first line therapy and discontinued part or all of first line therapy.
  -  Estimated life expectancy > 3 months.
  -  Stage IV disease.
  -  Eastern Cooperative Oncology Group (ECOG) 0-2.
  -  Adequate hepatic and hematologic function
  -  No major operations within 4 weeks prior to treatment start.
  Exclusion Criteria:
  -  More than 1 prior chemotherapy regimen for stage 4 colorectal cancer.
  -  Experimental medical treatment within 30 days prior to study entry.
  -  Known or suspected cerebral metastases.
  -  History or presence of any form of cancer, other that colorectal cancer, within the 3 years prior to enrollment.
  -  Known dihydropyrimidine dehydrogenase-deficiency (special screening not required).
  -  Subjects with angina pectoris, poorly controlled ventricular arrhythmias (does not include asymptomatic, occasional premature ventricular contractions), history of clinically significant coronary heart disease or cardiomyopathy, or ECG abnormalities consistent with ischemia.
  -  Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
  -  Clinically active liver disease, including active hepatitis (any etiology) or cirrhosis.
  -  Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) within 21 days prior to randomization
  -  Prior irinotecan therapy for metastatic disease is not permitted.
  -  Systemic fungal, bacterial, viral, or other infection.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Summary: 1. Trial design: Prospective observational study
  2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria
  3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
  -  C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
  4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
  5. Duration of Trial Recruitment: 2 years


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  19~80 year old male or female
  -  Histologically proven advanced or metastatic NSCLC
  -  Failed to 1st line chemotherapy
  -  Tumor tissue for genetic analysis
  -  Evaluable target lesion by RECIST v1.1
  -  ECOG performance from 0 to 3
  -  Expected survival more than 12 weeks
  Exclusion Criteria:
  -  Previous treatment of EGFR-tyrosine kinase inhibitors
  -  Severe hypersensitivity to erlotinib
  -  Residual toxicities (above grade 2) after previous chemotherapy
  -  Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: The Real Clinical Background of Advanced Colorectal Cancer Treatment Situation Survey

Summary: Collect the real clinical background of advanced colorectal cancer c of China.

Detailed description: The Primary Objectives of this study is collect the real clinical background of advanced colorectal cancer treatment situation of China. The Secondary Objectives is the mutation of K-ras , targeting therapy , use present situation of cetuximab and liver metastases treatment situation of colorectal cancer patients.

Eligibility: Inclusion Criteria:
  -  Patients with histologically or cytologically confirmed diagnosis of metastatic colorectal cancer.
  Exclusion Criteria:
  -  Patients with histologically or cytologically confirmed diagnosis other than metastatic colorectal cancer.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

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: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases

Summary: The purpose of this trial is to study health related quality of life (HQoL)after resection of colorectal liver metastases combined with perioperative chemotherapy. The investigators want to study if an aggressive, life prolonging and multimodal treatment can be defended from a quality of life perspective.

Detailed description: Background: Hepatic resection is the only treatment with potential curative intent for patients having colorectal liver metastases. Combined with chemotherapy, the overall 5-year survival is 40-50%. The disease free 5-year survival is about 20%, and about 70% of resected patients experience recurrence from their disease. Even if surgery is superior all other treatments, most patients will finally die from their cancer. However; surgery contributes by adding years of life, and for a minority, a disease free life. There has been much effort to study predictors for outcome after surgery, but little has been focused on quality of life following this treatment.
  Method: EORTC Validated questionnaire (European Organisation Research of Treatment of Cancer) version QLQ-C30 (3.0) and QLQ LMC21. The patients fill out the questionnaire before surgery as a baseline, and then after 3,6 and 12 months after surgery. The investigators also register important clinicopathological data about each patient prospectively.

Eligibility: Inclusion Criteria:
  -  Liver metastasis from colorectal cancer
  -  Resectability, with intension of R0 resection
  -  No macroscopic tumor left after surgery
  -  Patients with combined resectable extrahepatic tumors are also included.
  -  Patients must complete the questionnaire before the operation.
  Exclusion Criteria:
  -  Drop out of questionnaire after surgery
  -  Patients found to be irresectable during the operation or where macroscopic tumor tissue are left behind.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Identification the Expression of Sox2 in Colorectal Cancer Tissues

Summary: Sox2 has been studied in several types of human solid tumors. The investigators found that Sox2 had higher expression level in colorectal cancer and metastatic tissues than normal tissues. So the investigators assumed that whether Sox2 plays an important role in the progression and migration of colon cancer.

Detailed description: In our study, we examined Sox2 expression in archived human colon cancer tissues and found that its Sox2 expression correlates with reduced patient survival, increased tumor grade and metastasis probability.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colorectal cancer
  Exclusion Criteria:
  -  Clinical diagnosis characteristics not exactly described in the patients information

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Study of the Association of Nonalcoholic Fatty Liver Disease With Colorectal Malignant Neoplasm

Summary: The aim of this sudy is to investigate the prevalence of colorectal cancer (CRC) in patients with nonalcoholic fatty liver disease (NAFLD) and evaluate whether NAFLD is a risk factor for CRC.

Detailed description: As one of the most common cancer worldwide, colorectal cancer (CRC) is a major cause of cancer death in Asian countries. And during the past three decades, the incidence of CRC has been increasing rapidly in china. Many studies supported that cigarette smoking, obesity and insulin resistance were associated with CRC. In recent years, metabolic syndrome (MetS) - Including glucose tolerance, dyslipidemia, obesity, hypertension and chronic inﬂammation - and its individual components have been proven to be the risk for colorectal neoplasm. Colonoscopy is the most accurate technique for diagnosis, surveillance and exclusion of colorectal neoplasm for high-risk CRC groups. Therefore, improved risk stratiﬁcation knowledge of the target population is necessary to improve CRC patients' prognosis.
  Nonalcoholic fatty liver disease (NAFLD) is the most prevalent chronic liver disease worldwide and cause a wide spectrum of liver damage, such as steatohepatitis, cirrhosis, even end-stage liver disease and hepatocellular carcinoma. NAFLD has been found to be associated with obesity, insulin resistance, hypertension and dyslipidemia, and is considered as a liver manifestation of MetS. Although it has been also well established that MetS and its individual components are risk factors for colorectal neoplasm, as above, there is paucity of research looking at the relation between NAFLD and CRC. Therefore, the investigators aimed to investigate the prevalence of CRC in patients with NAFLD and evaluate whether NAFLD is an independent risk factor for CRC.

Eligibility: Inclusion Criteria:
  -  Patients had colonoscopy and
  -  Patients had conventional inspections(blood routine, liver function test and abdomen B ultrasonography)
  Exclusion Criteria:
  -  Patients were excluded with history of colorectal cancers or polyps, other extraintestinal malignancies and contraindications to colonoscopy.
  -  Patients were excluded who had viral hepatitis, cirrhosis, liver cancer or other liver disease.
  -  Patients ere excluded who drank more than 20g alcohol per day.

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer, Colon Cancer in the Adjuvant Setting, Advanced Gastric Cancer or Breast Cancer

Summary: This multi-center observational study will evaluate the use of Xeloda (capecitabine) in patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer and breast cancer in routine clinical practice. Eligible patients receiving treatment with Xeloda according to product label will be followed for up to 10 months.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic colorectal cancer, colon cancer in the adjuvant setting, advanced gastric cancer or breast cancer who are candidates for receiving Xeloda according to product label
  Exclusion Criteria:
  -  Contraindications according to label and off-label use

Relevance to patient case: not relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers

Summary: Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.
  Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.
  The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility: Inclusion Criteria:
  -  Has not yet started treatment for the identified cancer
  Exclusion Criteria:
  -  medically compromised patients
  -  congenital syndromes
  -  being treated with radiotherapy or chemotherapy.

Relevance to patient case: not relevant