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

Clinical trial: Study of Fruquintinib in Patients With Metastatic Colorectal Cancer（CRC）

Summary: Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced CRC in phIb study.
  This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

Detailed description: This is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to compare the efficacy and safety of Fruquintinib plus Best Supportive Care (BSC) versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy.
  After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1.
  Primary Efficacy Endpoint:
  Progression free survival (PFS) (According to RECIST Version 1.1).
  Secondary Efficacy Endpoints:
  Objective Response Rate (ORR), Disease Control Rate (DCR), Overall Survival (OS).
  Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Eligibility: Inclusion Criteria:
  -  ≥ 18 and ≤ 75 years of age , with ≥ 40Kg
  -  Histological or cytological confirmed metastatic colorectal cancer
  -  ECOG performance status of 0-1
  -  Failed 2 or more lines of chemotherapy
  -  Adequate hepatic, renal, heart, and hematologic functions
  -  At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  -  Signed and dated informed consent.
  -  Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Any factors that influence the usage of oral administration
  -  CNS metastasis
  -  One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
  -  Abuse of alcohol or drugs
  -  Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
  -  Disability of serious uncontrolled intercurrence infection
  -  Proteinuria ≥ 2+ (1.0g/24hr)
  -  Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
  -  History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
  -  History of acute myocardial infarction, acute coronary syndrome or CABG in 6 months
  -  Bone fracture or wounds that was not cured for a long time
  -  Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

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

Clinical trial: Preliminary Evaluation of Septin9 in Patients With Hereditary Colon Cancer Syndromes

Summary: This is an observational, case-control study evaluating the quantitative level of Septin9 in plasma pre- and post-colectomy in hereditary colorectal cancer (CRC) syndrome patients (Familial Adenomatous Polyposis (FAP), Lynch syndrome (also known as HNPCC), and Multiple Adenomatous Polyposis (MAP, also known as MYK/MYH) cases) and genetically related FAP-family members as controls and references.


Eligibility: Inclusion Criteria:
  -  Informed consent provided
  -  Age > or = to 18 years of age
  -  Patient group FAP
  - Clinical diagnosis of familial adenomatous polyposis
  -  Patient group Lynch syndrome Clinical diagnosis of Lynch syndrome
  -  Patient group MAP
  - Clinical diagnosis of MYH-associated polyposis and presence of more than 20 colon polyps
  -  Control group (FAP)
  - Genetically related family member of patient
  -  Patients: Able and willing to attend routine follow-up as advised
  -  Controls, i.e. relatives of patients: Willingness to give blood at each routine follow-up as advised for the diseased relative
  Exclusion Criteria:
  -  Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)
  -  Current diagnosis of colorectal cancer
  -  Pregnancy

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

Clinical trial: Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

Summary: Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12 administrations) in patients with metastatic colorectal cancer.


Eligibility: Inclusion Criteria:
  -  Patients with metastatic colorectal cancer International Union Against Cancer (UICC) Stage IV who are progressive under at least two previous chemotherapy regimes or who refused conventional treatment or who are not eligible for conventional treatment
  -  Progressive disease documented by subsequent computed tomography (CT) or magnetic resonance imaging (MRI) scanning prior to study entry. The last CT or MRI scans must be performed within 1 month before study entry. The first CT or MRI scan should be conducted within 6 months before study entry
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  -  Expected survival of ≥ 6 months
  -  Greater than or equal to 18 years of age
  -  Platelet count ≥ 100 x 10**9/L
  -  Total leukocytes ≥ 2500/mm**3
  -  Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 4 x upper limit of normal
  -  Total bilirubin ≤ 2.0 mg/dl (or 34µmol/L, Systeme International (SI) unit equivalent)
  -  Serum creatinine ≤ 2.0 mg/dl (0.20 mmol/l)
  -  Written informed consent in accordance with Good Clinical Practice and local legislation
  Exclusion Criteria:
  -  Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
  -  Exposure to an investigation agent within 30 days prior to the first BIBH 1 infusion
  -  Patients who are not fully recovered from surgery (incomplete healing)
  -  Chemotherapy or immunotherapy within 30 days prior to the first BIBH 1 infusion
  -  Radiation therapy to the symptomatic sites included for tumour measurements within 30 days prior to study entry
  -  Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment (e.g. BIBH 1, Panorex)
  -  Serious illness: e.g., active infections requiring antibiotics, bleeding disorders, patients with known untreated or unstable coronary heart disease (e.g. unstable angina or myocardial infarction within 6 months prior to study entry) or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
  -  Women who are breast-feeding or pregnant
  -  Men and women of childbearing potential who are unwilling to utilise a medically acceptable method of contraception
  -  Patients who suffer from autoimmune 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: A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer

Summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.

Detailed description: Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models.
  The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities.
  Based on these results, is study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed metastatic breast cancer relapsed or refractory to approved standard available treatment
  -  Prior treatment with standard first line therapy in the metastatic setting
  -  Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q amplification status
  -  Demonstrated progression of disease by radiological or clinical assessment (Measurable disease according to RECIST Version 1.1 is NOT required for enrollment)
  -  Estimated life expectancy >6 months
  Exclusion Criteria:
  -  Current or recent treatment with biologic anticancer therapies
  -  Ongoing AEs from prior anticancer therapies
  -  Active central nervous system (CNS) metastases
  -  Clinically significant or uncontrolled hypertension or cardiac disease
  -  Females who are pregnant or breastfeeding

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

Clinical trial: Liver Enzymes and Fluid Balance Following Colorectal Surgery

Summary: The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery.
  Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.


Eligibility: Inclusion Criteria:
  -  Patients undergoing colorectal surgery
  Exclusion Criteria:
  -  Severe cardiac failure Severe renal failure Severe liver failure

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 Study of Combining Ultrasound Microbubbles and Chemotherapy to Treat Malignant Neoplasms of Digestive System

Summary: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects. The main purpose is to identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.

Detailed description: Ultrasonic sonoporation can increase the release of chemotherapeutics, thus increasing the therapeutic effects.
  1. Main purpose
  1. To identify the safety of combining ultrasonic microbubbles and chemotherapeutics to treat malignant neoplasms of hepatic metastases from alimentary system and pancreatic carcinoma.
  2. To explore the largest mechanical index and ultrasonic treatment time which patients can endure.
  2. Secondary purpose
  1. To observe tumor clinical benefit rate (CR+PR+SD).
  2. To evaluate the preliminary effect,such as time to failure(TTF), time to death(TTD)

Eligibility: Inclusion Criteria:
  -  Pathological diagnosis of liver metastases from alimentary system and pancreatic carcinoma
  -  Failed routine chemotherapy
  -  Neoplasms can be evaluated by imaging
  -  ECOG《2
  Exclusion Criteria:
  -  Have systematic chemotherapy in 2 weeks
  -  Be allergic to ultrasonic microbubbles and chemotherapeutics
  -  Uncontrolled high blood pressure, cardiovascular disease
  -  Active bleeding
  -  Have serious mental and psychological 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: Phase 1 Study of E7090 in Subjects With Solid Tumor

Summary: This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:
  1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
  2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.


Eligibility: Inclusion Criteria: Part 1and Part 2
  1. Provide written informed consent
  2. Male or female subjects age >= 20 years at the time of informed consent
  3. Subjects with a histological and/or cytological diagnosis of solid tumor
  4. Subjects who failed standard therapies, or for which no appropriate treatment is available.
  5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
  6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
  Inclusion Criteria: Part 2 only
  7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
  Exclusion criteria
  1. Patients with brain metastasis who have clinical symptoms or requiring treatment.
  2. Medical history of clinically significant cardiovascular impairment
  3. Concomitant systemic infection requiring medical treatment
  4. Effusion requiring drainage
  5. Known intolerance to the study drug (or any of excipients)
  6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
  7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.
  8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
  9. Females who are pregnant or breastfeeding
  10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.

Relevance to patient case: possibly relevant
Patient case: 35-year-old female with Colorectal cancer. Genetic variant: FGFR1 Amplification. Other conditions: None.

Clinical trial: Physical Activity in Relation to Surgical Procedures

Summary: This study will compare the outcome after surgery between a group of patients that receives instructions for prehabilitation training and one group that received standard treatment.

Detailed description: The aim of this study is to investigate whether a training program with intensified physical activity prior to and after a surgical procedure reduces the surgical-related postoperative recovery time, hospital stay, sick leave and complication rate.
  A secondary aim is to investigate the effect of a training program with pre- and post- operative PA on the rate of resumption of QoL and normal physical function.

Eligibility: Inclusion Criteria:
  -  Diagnosed colorectal cancer and a planned surgical procedure
  Exclusion Criteria:
  -  HIPEC surgery, not able to give informed consent or understand the intervention

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 Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer

Summary: This study seeks to evaluate the efficacy and tolerability of veliparib in combination with FOLFIRI +/- bevacizumab in previously untreated, metastatic adenocarcinoma of the colon or rectum. FOLFIRI is a chemotherapy regimen of fluorouracil, leucovorin and irinotecan.
  This is a blinded study such that the Investigator and Subject will be blinded but AbbVie will be unblinded.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
  -  At least 1 unresectable lesion on a CT (Computerized Tomography) scan that is measurable as defined by RECIST, Version 1.1
  -  ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1
  -  Adequate hematologic, renal and hepatic function
  Exclusion Criteria:
  -  Prior anti-cancer treatment for metastatic colorectal cancer
  -  Prior exposure to PARP (poly ADP-ribose polymerase) inhibitors
  -  The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to colorectal cancer recurrence
  -  Any clinically significant and uncontrolled major medical condition
  -  Participant is pregnant or lactating
  -  Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities
  -  For those receiving bevacizumab, standard medical exclusionary conditions 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: Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Summary: 300 patients with colorectal cancer will be investigated before surgery and 60 of them will also be investigated in the same manner after surgery. Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and a questionnaire, but only before surgery including questions on sleep, sleep apnea, lung disorders.
  Outcome: side effects of surgery and mortality rate, association with cancer type.
  Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after surgery.

Detailed description: Group 1. Inclusion: 240 patients with colorectal cancer scheduled for surgery. Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before surgery with Lung-function measurements, blood-gas sample, questionnaire, Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality, Sleep apnea, hypxoia, hyprecapnia and effect on lungfunction (VC, FEV1). Detailed morphologic analysis of cancer type.
  Group 2. Inclusion: 35 patients with colorectal cancer scheduled for open surgery, Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.
  Group 3. Inclusion: 25 patients with colorectal cancer scheduled for laparoscopic or robot surgery.
  Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
  Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for surgery of colorectal cancer
  Exclusion Criteria:
  -  Dementia, CPAP treatment for obstructive sleep apnea

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

Clinical trial: Clinical Trial of Quantitative Detection Kit for Hsp90α in Colorectal Cancer

Summary: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients.

Detailed description: Detect plasma Hsp90α concentration of colorectal cancer patients, healthy volunteers, benign colorectal diseases patients, validate accuracy, specificity and sensitivity of Hsp90α kit.

Eligibility: Inclusion Criteria:
  -  colorectal cancer patients, healthy volunteers, benign colorectal diseases patients
  Exclusion Criteria:
  -  Patients who previously accepted radiotherapy

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

Clinical trial: Metagenomic Evaluation of the Gut Microbiome in Patients With Lynch Syndrome and Other Hereditary Colonic Polyposis Syndromes

Summary: The purpose of this study is to understand the role bacteria that normally live in the colon may play in colorectal cancer risk, in addition to the hereditary risk to colorectal cancer. The investigators will collect stool specimens as well as additional colon biopsy specimens during the patient's scheduled colonoscopy procedure. The investigators will also collect a questionnaire about diet and lifestyle. The samples will be used to study the impact of diet on naturally-occurring oral and gut bacteria and their influences on human health including risk of cancer.


Eligibility: Inclusion Criteria:
  -  Male or Female age 18 or older
  -  Hereditary colorectal cancer syndrome with one of the following:
  -  Lynch syndrome, as defined by the presence of a deleterious germline mutation in the MLH1, MSH2, MSH6, PMS2 or EPCAM genes
  -  Other hereditary colonic polyposis syndromes, as defined by the presence of a deleterious germline mutation in any one of the following polyposis genes (APC, biallelic MYH, STK11, SMAD4, BMPR1A, or other CRC-risk associated genes at discretion of PI)
  Exclusion Criteria:
  -  Unable to provide informed consent for testing
  -  Unable to complete English language questionnaire
  -  Receiving active chemotherapy
  -  Having completed active chemotherapy less then 12 months prior to day of scheduled lower endoscopy
  -  No infectious or drug induced colitis less then 12 months prior to day of scheduled lower endoscopy
  -  No history of inflammatory colitis (Crohn's disease or ulcerative colitis)

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

Clinical trial: Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?

Summary: Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.

Detailed description: Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests

Eligibility: Inclusion Criteria:
  -  patients with colorectal carcinoma after have been diagnosed
  Exclusion Criteria:
  -  Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.

Relevance to patient case: not relevant