araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Surgicel® Fibrillar for Delayed Bleeding After ESD

Summary: The aim of this study is to assess the effect of Surgicel® Fibrillar as adjuvant treatment to H2RA on preventing ulcer bleeding after ESD for gastric epithelial tumors

Detailed description: 1. Patient (1) Inclusion: Diagnosed as gastric dysplasia or early gastric cancer
  -  Scheduled for ESD (2) Exclusion: Coagulopathy- liver cirrhosis, thrombocytopenia
  -  Anti-platelet agents
  2. Method
  (1) Study group: combination with Surgicel® Fibrillar and H2RA (2) Control group: monotherapy with PPI 3. Sample size : 157 4. Result
  1. Primary endpoint: rate of delayed bleeding after ESD
  2. Secondary endpoint: follow-up hemoglobin after ESD

Eligibility: Inclusion Criteria:
  -  ESD for gastric dysplasia or early gastric cancer
  Exclusion Criteria:
  -  Coagulopathy: liver cirrhosis, thrombocytopenia
  -  Anti-platelet agents

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC

Summary: Lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.
  Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.
  Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.
  Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.
  However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.
  Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.
  Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.


Eligibility: Inclusion Criteria:
  1. Histological confirmed non-small cell lung cancer (NSCLC), Stage IIIB or stage IV, between January 1, 2008 to December 31, 2011
  2. Confirmed EGFR rare mutations (EGFR mutation except both exon 19 deletion and exon 21 L858R) using direct DNA sequencing
  3. Experiences of treatment with EGFR TKIs.
  4. at least one measurable and/or evaluable lesion according to RECIST criteria (version 1.1)
  Exclusion Criteria:Subjects should not enter the study if any of the following exclusion criteria are fulfilled: EGFR wild type, EGFR exon 19 deletion alone, EGFR L858R alone

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Summary: To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.


Eligibility: Inclusion Criteria:
  -  1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
  Exclusion Criteria:
  -  1. Active infection 2. Active bleeding

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Europe-Japan Diagnostic Study for EGFR Testing

Summary: This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

Detailed description: A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,

Eligibility: Inclusion Criteria:
  -  Patients aged 18 years and older in Europe and aged 20 years and older in Japan
  -  Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
  -  Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
  -  Provision of diagnostic cancer tissue or cytology sample upon inclusion
  -  Provision of a routine blood sample
  Exclusion Criteria:
  -  Evidence of severe or uncontrolled systemic disease
  -  Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
  -  Pregnancy or breast-feeding

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer

Summary: This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.

Detailed description: This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.

Eligibility: Inclusion Criteria:
  1. Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma.
  2. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent.
  3. Subjects with EGFR overexpression (2+ or 3+ in IHC)
  Exclusion Criteria:
  1. Subjects who have received irinotecan
  2. Subjects who have received EGFR-directed therapy
  3. Other active malignancy within the last 5 years

Relevance to patient case: definitely relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Density of Neurons in the Stomach and Prognosis of Gastric Adenocarcinoma

Summary: Preclinical studies at our institution, based on a genetic mouse model of stomach cancer, strongly suggest that innervation of the stomach wall is deeply involved in tumorigenesis of stomach cancer. The data indicate that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®)in the stomach wall inhibits the development of cancer as well as reduces already established tumor volume in the stomach in this mouse model. Gene expression data indicate that vagotomy suppresses protein gene product 9.5 (PGP9.5). The expression of PGP9.5 is highly specific for the density of neurons and the diffuse neuroendocrine system. The investigators will take biopsies from tumors and adjacent normal mucosa either by means of endoscopy and/or from operative specimens from participants treated or evaluated for stomach cancer at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital. The biopsies will be evaluated with immunohistochemistry and gene expression studies for the presence and density of PGP9.5. These data will be correlated to stage evaluation (TNM) and survival.


Eligibility: Inclusion Criteria:
  -  Fifteen patients evaluated- or treated for suspected or verified gastric adenocarcinoma at the Department of Gastrointestinal Surgery, St Olavs Hospital, Trondheim University Hospital
  -  informed consent
  Exclusion Criteria:
  -  General contraindications for endoscopy with biopsies (i.e. bleeding disorders or use of anticoagulants).

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Botulinum Toxin for Stomach Cancer Treatment

Summary: Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.


Eligibility: Inclusion criteria:
  Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:
  1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
  2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
  3. Patients who, after meticulous information about chemotherapy, still do not want such treatment.
  4. Patients with performance status (ECOG) 0-2.
  Exclusion criteria:
  1. Known allergy to any of the components in Botox®
  2. Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert`s Syndrome).
  3. Pregnant or lactating women.
  4. Another cancer disease that is not under control.
  5. Another concomitant treatment for cancer.
  6. Serious mental illness.
  7. Performance status (ECOG) 3-4.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Exercise Time in Sedentary Middle-aged Female

Summary: The exercise time is an important factor among the medical guides for weight loss; however, there is still little knowledge about exercise duration paths in middle-aged and older women. The present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

Detailed description: Participants included sedentary women (age 45-75 years) with overweight or obesity (n= 115). They were randomly divided into two groups including continuous exercise, and interval exercise. The weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility: Inclusion Criteria:
  -  Sedentary lifestyle
  -  Good Health
  -  Weight stability
  Exclusion Criteria:
  *Abnormality or history of Disease

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil

Summary: Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but it is limited to use alone. The investigators designed this study to compare the effect and safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.


Eligibility: Inclusion Criteria:
  -  Age ≥20
  -  American Society of Anaesthesiologists(ASA) physical status classification I~III
  -  Early gastric cancer patients who were scheduled for Endoscopic submucosal dissection
  Exclusion Criteria:
  -  Age < 20
  -  American Society of Anaesthesiologists(ASA) physical status classification IV
  -  those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
  -  known drug allergies or history of drug abuse
  -  psychological disease

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Evaluation of Symptoms Improvement in NSCLC Patients With First-Line Therapy of EGFR Tyrosine Kinase Inhibitor

Summary: This is an open-label, non-interventional, single-arm, multicenter study in a real-world population to assess the clinically symptom improvement and quality of life (QoL) in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment.
  The Primary Objective is to estimate symptom improvement rates in patients with locally advanced or metastatic NSCLC and positive EGFR mutation who receive EGFR-TKIs as the first-line treatment. A clinically meaningful improvement is defined as an increase from baseline of 2 or more points for LCS (Lung Cancer Scales) at Week 4.

Detailed description: The Secondary Objectives are:
  1. To estimate symptom improvement rates at weeks 2 and 12
  2. To estimate mean change from baseline in overall QoL scores using the FACT-L instrument and LCS score at Week 2, 4 and 12.
  3. To estimate the proportion of patients exhibiting an LCS change of 7 points or more at weeks 2, 4 and 12.
  4. Subgroup information of symptom improvement rate, QoL and disease-related symptom scores by gender, smoking status, smoking pattern, WHO performance, number of metastatic sites, female/never smokers and patients with COPD at week 2, week 4 and week 12.

Eligibility: Inclusion Criteria:
  -  Patients diagnosed with symptomatic, locally advanced or metastatic (stage IIIb/IV) NSCLC.
  -  Patients who are positive for EGFR mutation
  -  Patients with a prescription of EGFR-TKI as their first-line treatment
  Exclusion Criteria:
  - Involvement in any planning and/or conduct of the clinical trial.

Relevance to patient case: not relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification

Summary: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.

Detailed description: This is an open-label, multicenter, multinational, Phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification.
  The trial will consist of a screening period, a treatment period, and an end of treatment visit occurring when neratinib is discontinued for any reason, a safety follow-up visit occurring 28 to 42 days after the last dose of neratinib and a survival follow-up period lasting for a maximum of 12 months for each patient after their last dose of neratinib or until initiation of additional anti -cancer therapy.
  Treatment will consist of neratinib alone 240 mg daily in all HER2 mutated cancers excluding hormone positive breast cancers and bladder cancers, or neratinib 240 mg daily and paclitaxel 80 mg/m^2 IV on Days 1, 8, and 15 of every 4 week cycle in bladder cancers , or neratinib 240 mg daily and fulvestrant 500 mg on Days 1, 15 of the first month, then Day 1 of every 4 week cycle in hormone positive breast cancers.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed cancers for which no curative therapy exists.
  -  Documented HER2 mutation.
  Exclusion Criteria:
  -  Prior treatment with any pan-HER TKI (eg, lapatinib, afatinib, dacomitinib, neratinib).
  -  Patients who are receiving any other anticancer agents.
  -  Symptomatic or unstable brain metastases.
  -  Women who are pregnant or breast-feeding.
  Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Relevance to patient case: possibly relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

Summary: This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.


Eligibility: Inclusion Criteria:
  -  18 years old at time of consent
  -  Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
  -  EGFR-positive tumor expression
  -  Adequate blood and organ function
  -  Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
  -  Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements
  Exclusion Criteria:
  -  Other anti-cancer treatment during the study
  -  Symptomatic brain metastases
  -  Other clinically significant disease as defined by the protocol
  -  Chronic skin condition that requires prescribed oral or intravenous treatment
  -  History of severe rash that required discontinuation of prior EGFR targeted therapy
  -  Receiving therapeutic doses of warfarin or heparin for anti-coagulation
  -  Known diagnosis of HIV or active viral hepatitis
  -  Women who are pregnant or breast feeding

Relevance to patient case: possibly relevant
Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Dose Escalation Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2849330 in Subjects With Advanced Her3-Positive Solid Tumors

Summary: Human Epidermal Growth Factor Receptor 3 (HER3) expression is seen across a wide variety of solid malignancies and is associated with poor prognosis. Up-regulation of HER3 expression and activity is also associated with resistance to multiple pathway inhibitors. GSK2849330, a monoclonal antibody targeting HER3, is a new agent for subjects whose tumors express HER3. This study is a phase I, first time in human, open-label, dose escalation study. The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849330 in subjects with advanced HER3-positive solid tumors. The study will be conducted in two parts. Part 1 (Dose-Escalation Phase) will include dose escalation and PK/PD cohorts to evaluate safety, PK, and PD to guide selection of dose regimen(s) for Part 2. In Part 2 (Expansion Cohorts), up to 3 cohorts will be enrolled at the dose regimen(s) selected based on Part 1 data, to evaluate safety in a larger cohort of subjects at the recommended dose regimen and also to evaluate preliminary evidence of clinical benefit.


Eligibility: Inclusion Criteria:
  -  Males and females >=18 years of age (at the time consent is obtained).
  -  Written informed consent provided.
  -  Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Sufficient archival tumor specimen is available for HER3 immunohistochemistry (IHC) analysis, or subject is willing to undergo a fresh tumor biopsy for HER3 IHC analysis.
  -  Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx).
  Exclusion Criteria:
  -  Subjects with leptomeningeal or brain metastases or spinal cord compression.
  -  Prior HER3- directed treatment (HER2- or EGFR-directed treatment is acceptable).
  -  Concurrent medical condition that would jeopardize compliance.
  -  Receiving chronic immunosuppressive therapies (includes daily steroid doses in excess of 20 milligrams [mg]/day of prednisone).

Relevance to patient case: not relevant