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

Clinical trial: Ph II Trial of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Second-line Treatment of Metastatic Colorectal Cancer

Summary: The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with irinotecan, 5-FU and leucovorin in the second-line treatment of subject with metastatic colorectal cancer


Eligibility: Inclusion Criteria:
  -  ECOG Performance Status (PS) ≤1
  -  Histologically or cytologically confirmed, unresectable metastatic colorectal cancer
  -  Measurable disease by RECIST guidelines
  -  Evidence of disease progression following first-line therapy with a fluoropyrimidine, oxaliplatin, and bevacizumab (≤ 8 weeks since last dose)
  -  Available paraffin embedded tumor tissue
  -  Willing to give a whole blood sample for the study of proteins and genetic polymorphisms
  Exclusion Criteria:
  -  Less than 28 days elapsed since major surgery at time of randomization
  -  Known CNS metastases
  -  Excessive risk of bleeding (including use of therapeutic anticoagulation other than low dose aspirin) and history of thrombotic or embolic cerebrovascular accident
  -  Uncontrolled hypertension
  -  Clinically significant cardiovascular disease
  -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  -  Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis
  -  Known HIV Positive

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

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

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


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

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

Clinical trial: Level of HER2-neu Gene Amplification an Response to Trastuzumab

Summary: Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.


Eligibility: Inclusion Criteria:
  -  HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
  Exclusion Criteria:
  -  HER2-negative advanced breast cancer Pretreatment with trastuzumab

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 S-1 Plus LV for Untreated Metastatic Colorectal Cancer

Summary: This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Histologically proved adenocarcinoma
  -  Unresectable and recurrent colorectal cancer
  -  Age20 ≤ at enrollment
  -  Performance status 0 or 1 (ECOG)
  -  No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
  -  Adequate hematologic, hepatic and renal functions
  -  At least one measurable lesion by RECIST criteria
  Exclusion Criteria:
  -  Serious drug hypersensitivity
  -  Pregnant or nursing
  -  Bleeding from gastrointestinal tract
  -  Diarrhea
  -  Simultaneously active double cancer
  -  Serious illness or medical condition
  -  Brain metastasis

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

Clinical trial: Immunoreactivity to Cetuximab in Cancer Patients

Summary: RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.
  PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

Detailed description: OBJECTIVES:
  -  To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.
  OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following:
  -  Head and neck cancer
  -  Advanced colorectal cancer
  -  Previously treated with cetuximab
  -  Serum samples available from patients enrolled in one of the following clinical trials:
  -  VU-VICC-GI-0410 (colorectal cancer)
  -  VU-VICC-GI-0622 (colorectal cancer)
  -  VU-VICC-HN-0356 (head and neck cancer)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Biomarkers of Angiogenesis and Disease in Patients With Unresectable Malignant Mesothelioma Treated on Clinical Trial CALGB-30107

Summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers of angiogenesis and disease in patients with unresectable malignant mesothelioma treated on clinical trial CALGB-30107.

Detailed description: OBJECTIVES:
  -  Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin portend a poor prognosis in patients with unresectable malignant mesothelioma treated with vatalanib on protocol CALGB-30107.
  -  Determine if elevated levels of thrombospondin I serum levels, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin correlate with response or stable disease in these patients.
  OUTLINE: Serum samples previously obtained from patients on protocol CALGB-30107 are tested for levels of thrombospondin I serum, vascular endothelial growth factor receptor I, fibroblast growth factor, transforming growth factor, and mesothelin using enzyme-linked immunosorbent assays (ELISA).
  PROJECTED ACCRUAL: A total of 47 specimens will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of malignant mesothelioma
  -  Unresectable disease
  -  Must have received treatment with vatalanib on protocol CALGB-30107
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

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

Clinical trial: Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Summary: Aims:
  1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.
  2. To determine the compliance and complications associated with both strategies.
  Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).
  Study groups:
  -  Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.
  -  Group II: colonoscopy.
  Sample-size calculation: 27,749 subjects in each study group (total: 55,498).


Eligibility: Inclusion Criteria:
  -  Men and women aged 50-69 years
  Exclusion Criteria:
  -  Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease
  -  Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)
  -  Severe comorbidity
  -  Previous total colectomy
  -  Not signed informed consent to participate

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

Clinical trial: Tumour Registry Colorectal Cancer

Summary: To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.

Detailed description: The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
  The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.

Eligibility: Inclusion Criteria:
  -  Colorectal cancer
  -  18 years and older
  -  Antineoplastic treatment
  Exclusion Criteria:
  -  No colorectal cancer
  -  Below 18 years
  -  No antineoplastic treatment

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

Clinical trial: Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

Summary: Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer


Eligibility: Inclusion Criteria:
  -  colorectal cancer
  Exclusion Criteria:
  -  metastases
  -  recurrent disease
  -  chronic diseases

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

Clinical trial: Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Summary: The aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

Detailed description: Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.
  Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.
  The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of colorectal cancer before the age of 70
  -  Diagnosed in one of the participating hospitals
  -  Able to read and understand Dutch
  Exclusion Criteria:
  -  Previous referral for genetic counseling

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 to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI

Summary: This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506 as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic CRC. It will also determine the impact of the combined administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506, oxaliplatin, 5 FU, and irinotecan.
  This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60 patients will be enrolled into this study to ensute that at least 12 - 15 patients for each combination regimen can be evaluated for safety and pharmacokinetics. For this reason a minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20 patients will receive FOLFIRI in combination with BAY73-4506.


Eligibility: Inclusion Criteria:
  -  Histological or cytological documentation of adenocarcinoma of the colon or rectum.
  -  At least 1 measurable lesion as per RECIST
  -  ECOG Performance Status of 0 - 1
  -  Life expectancy of at least 12 weeks.
  -  Adequate bone marrow, liver, and renal function
  Exclusion Criteria:
  -  More than 1 previous chemotherapy for Colorectal Cancer. Adjuvant chemotherapy for Colorectal Cancer (Stage I, II, II) is permitted, if the adjuvant therapy ended >6 month before screening.
  -  Previous FOLFOX treatment for patients who will be included in the mFOLFOX6 cohort apart from FOLFOX treatment in an adjuvant setting.
  -  Previous FOLFIRI treatment for patients who will be included in the FOLFIRI cohort.

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

Clinical trial: Inflammatory Response in Laparoscopic and Open Colectomy

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


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

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

Clinical trial: Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

Summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility: Inclusion Criteria:
  1. Female presenting with metastatic breast cancer.
  2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
  3. HER2 and HR status must have been determined.
  4. Patients must have HER2 negative breast cancer.
  5. Patients must have a documented disease progression as define by RECIST at baseline.
  6. Patients with HR+ disease:
  -  Must have received at least one prior endocrine therapy in the metastatic setting.
  -  Must have received no more than three lines of chemotherapy in the metastatic setting.
  7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
  Exclusion Criteria:
  1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
  2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  -  History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
  -  Clinically significant resting bradycardia (< 50 beats per minute).
  -  LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
  3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
  4. Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
  Other protocol-defined inclusion/exclusion criteria may apply

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 Continuing Care Needs in Colorectal Cancer Patients in Different Stages

Summary: The aims of this study are to:
  1. explore supportive care needs in colorectal cancer patients with treatment and survivors;
  2. compare the supportive care needs in different stage of colorectal cancer;
  3. identify the significant factors for the supportive care needs;
  4. explore the supportive care needs within one year after newly diagnosis.

Detailed description: Both large scale cross-sectional survey and a prospective 1-year longitudinal panel study design will be used in this study. The cross-sectional survey is to examine the current status of supportive care needs perceived by different stage of colorectal cancer inpatients and outpatients including survivors. The 1-year longitudinal design is to explore the change of supportive care needs perceived by patients within one year after newly diagnosed with colorectal cancer.

Eligibility: Inclusion Criteria:
  -  Patients with colorectal cancer in any stage or survivors
  -  Those who are willing to participate in the research
  -  Aged above 18
  Exclusion Criteria:

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 Behaviors in Patients Who Have Finished Treatment for Stage I, Stage II, or Stage III Colorectal Cancer

Summary: RATIONALE: Gathering information over time from patients who have finished treatment for colorectal cancer may help doctors predict which cancer survivors will improve their physical activity and diet.
  PURPOSE: This clinical trial is studying health behaviors in patients who have finished treatment for stage I, stage II, or stage III colorectal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To characterize patterns and identify predictors of post-treatment physical activity and dietary changes made by colorectal cancer survivors.
  Secondary
  -  To identify the affective and cognitive effects of post-treatment physical activity and dietary changes in these patients.
  -  To identify these patients' preferences regarding diet and physical activity health promotion programs.
  OUTLINE: This is a multicenter study.
  Patients complete surveys at baseline and at 3 and 6 months. A randomly selected subset of 84 patients also receive an activity monitor to be use at each of the 3 time points. The acceptability of their use is assessed and whether activity levels change across the 3 time points and the extent to which they are convergent with self-reported physical activity are examined.
  During each survey, questionnaires are administered to assess the following areas: physical/medical characteristics (self-reported), self-efficacy for physical activity, fruit and vegetable consumption, and dietary fat intake; outcome expectations for physical activity, fruit and vegetable consumption, and dietary fat intake; physical activity and diet behavioral self-regulation; illness representations (causal attributions and controllability of recurrence); perceived risk of colorectal cancer (CRC) recurrence; emotional representations of CRC (cancer-related anxiety and worry about cancer recurrence); healthcare provider recommendations to alter physical activity and dietary intake; social influence from important others; current physical activity and dietary intake; and diet and physical activity program preferences. Patients who received the activity monitor are asked feedback on acceptability of them.
  Measures of sociodemographics and disease/treatment characteristics (via medical chart review) are recorded.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of localized or regional colorectal cancer
  -  Stage I, II, or III disease
  -  Completed treatment within the past 6 weeks
  -  No previous diagnosis of colorectal cancer
  PATIENT CHARACTERISTICS:
  -  English speaking
  -  No current evidence of neoplastic disease except for nonmelanoma skin cancer
  -  No evidence of severe cognitive impairment
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant