araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

Summary: Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer.
  Recently developed hemostatic powder [Endo-Clot(TM)] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility & safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.


Eligibility: Inclusion Criteria:
  -  Age over 19 and less 80 yeas old
  -  Gastric cancer was diagnosed with biopsy and/or computed tomography
  -  Endoscopic hemostasis is needed upto GI hemorrhage
  -  Endoscopic examination is available in 24hours
  -  ECOG performance status(PS) <2
  Exclusion Criteria:
  -  Double primary caner
  -  Hypersensitivity of hemostatic power[Endo-Clot(TM)]
  -  Variceal bleeding or benign gastric ulcer bleeding
  -  Hemodynamically unstable with low systolic BP<90mmHg and/or tachycardia PR>120bpm
  -  endoscopic hemostasis within 7 days before screening
  -  Contraindication for endoscopic examination
  -  Pregnant
  -  Breast feeding
  -  bleeding tendency with low platelet count <50,000 /mm^3 and/or INR>2
  -  Bacterial infection with needs for antibiotics therapy
  -  Unavailable to discontinue anti-coagulation agent for 3days
  -  Vascular shunt
  -  Cardiovascular and/or pulmonary diseases
  -  Active hepatitis or severe liver diseases
  -  Renal dysfunction
  -  Bone marrow dysfunction
  -  Neurologic deficit and/or psychotic feature
  -  Unavailable informed consent

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Summary: The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.
  The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).


Eligibility: Inclusion criteria:
  -  Recurrent or metastatic urothelial cancer
  -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  -  Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  -  Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  -  Further inclusion criteria apply
  Exclusion criteria:
  -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  -  Further exclusion criteria apply

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Difference of Gastric Microbiota in the Process of Correa's Model.

Summary: Helicobater pylori plays an important role in the development of gastric cancer. Eradication therapy can reducing the morbidity of gastric cancer, but can't totally prevent it especially when atrophy and more serious precancerous lesions already happened. Prior studies found the gastric bacterial difference among gastritis, intestinal metaplasia and gastric cancer. However, they didn't reach an agreement. Correa's model is widely accepted in the development of gastric cancer. The pathological change makes a more suitable environment for bacteria to overgrowth. This study are designed to analyze the gastric microbial difference of non-atrophic gastritis, atrophic gastritis, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.


Eligibility: Inclusion Criteria:
  1. Patients go through a gastric endoscopy examination with non-atrophic gastritis, atrophic gastris, intestinal metaplasia, intraepithelial neoplasia and gastric cancer.
  2. Did not take any antibiotics,PPI,probiotics and chinese herbs in the past one month,and took less than one week in the past three months before the gastroscopy examination.
  3. Sign the informed consent.
  Exclusion Criteria:
  1. Had been taken Helicobacter pylori eradication therapy before.
  2. Previous gastrointestinal surgery.
  3. During the pregnancy and lactation period.
  4. With any serious diseases like liver failure,heart failure,renal failure,malignant tumor,alcoholism or any other disease that may effect the result.
  5. With any mental problems.

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

Summary: Background: Gastric cancer (GC) is major global health concern and the second leading cause of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity of Her2/neu overexpression and amplification in GC should be noticed. The investigators investigated the significance of evaluating Her2/neu expression in different paraffin blocks of tumor tissue in GC.
  Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry (IHC). In cohort 2, the investigators combined the results from two different paraffin blocks and used the higher one as the final score.


Eligibility: Inclusion Criteria:
  -  Undergone curative surgery of gastric cancer,
  -  18-80 years old.
  Exclusion Criteria:
  -  None

Relevance to patient case: definitely relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma

Summary: The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).


Eligibility: Inclusion Criteria:
  -  Patient > 18 years old
  -  Head and neck squamous cell carcinoma diagnosed by biopsy
  -  N0 classification (N0: no lymph node invasion on clinical and radiological examination).
  -  Neck dissection or sentinel lymph node biopsy required to treat the patient
  -  ECOG 1,2 or 3
  -  Patient's consent
  Exclusion Criteria:
  -  Patient previously treated by radiotherapy or surgery for head and neck neoplasm.
  -  Contraindication or patient unwillingness to undergo surgical treatment
  -  Incapacitated adults

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Significance of Circulating Tumor Cells in the Treatment of Gastric and Rectal Cancer

Summary: The primary purpose of this study is to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Detailed description: Laparoscopic surgery represents a milestone for treatment of gastric and rectal cancer, with advantages of minimal invasion and rapid recovery compared to open approach. However, for progressive gastric and rectal cancer, laparoscopic approach has not been officially promoted by NCCN guideline (2015).
  Over the past decade, circulating tumor cells (CTCs), originated from a tumor cell, have been identified as potential blood-based biomarkers capable of providing prognostic and predictive Information.
  In the present study, the investigators utilize the CTCBIOPSY® system (YZYBIO Company, Wuhan, China), which has been approved by CFDA (Chinese Food and Drug Administration), to detect CTCs, and try to compare both short-term and long-term treatment effect of laparoscopic vs. open approach on progressive gastric and rectal cancer, based on circulating tumor cell (CTC) test results as well as disease-free survivals, and figure out principles of laparoscopic approach for progressive gastric and rectal cancer. Secondary purpose is to establish an evaluation system for laparoscopic surgery for progressive gastric and rectal cancer treatment using CTC as a biomarker.

Eligibility: Gastric cancer
  Inclusion Criteria:
  -  Gastric cancer of stage II/III
  Exclusion Criteria:
  -  History of malignant tumors
  -  Gastric cancer of stage Ⅳ
  -  Preoperative neoadjuvant chemotherapy
  -  History of upper abdominal surgery
  -  Severe other contradictions of surgery
  Rectal cancer
  Inclusion Criteria:
  -  Primary rectal carcinoma
  -  Single lesion
  -  No metastasis
  -  Sphincter-saving surgery available
  Exclusion Criteria:
  -  History of malignant tumors
  -  Acute bowel obstruction, bleeding or perforation
  -  Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
  -  Severe other contradictions of surgery

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer

Summary: Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.


Eligibility: Inclusion Criteria:
  -  local advanced or metastatic non-small cell lung cancer
  -  large cell lung carcinoma or adenocinoma
  -  Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
  -  EGFR T790M positive
  -  No uncontrolled hypertension
  -  No active bleeding or thrombosis in recent 6 months
  -  No previously treated with VEGF antibody
  Exclusion Criteria:
  -  newly diagnosed thrombosis
  -  anti-coagulation therapy
  -  uncontrolled hypertension
  -  uncontrolled nephropathy

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

Summary: Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.

Detailed description: Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.

Eligibility: Inclusion Criteria:
  -  Suspected of having a cancerous lesions
  -  The age of patients is from 40-80 years
  -  Patients must undergo esophagogastroduodenoscopy
  Exclusion Criteria:
  -  Clinical diagnosis of advanced gastric cancer
  -  Acute upper gastrointestinal bleeding
  -  Severe systemic diseases
  -  Refuse to attend the study

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

Summary: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

Detailed description: First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
  Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma positive EBUS-TBNA specimen
  Exclusion Criteria:
  -  other diagnosis

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Trastuzumab Based Therapy in HER2 Positive AGC

Summary: Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

Detailed description: A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Eligibility: Inclusion Criteria:
  1. pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
  2. received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
  3. with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
  4. Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
  5. left ventricular ejection fraction(LVEF) more than 50 percents;
  6. sufficient bone marrow, liver and renal function.
  Exclusion Criteria:
  1. received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
  2. trastuzumab based adjuvant/neoadjuvant therapy;
  3. treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
  4. patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
  5. trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.

Relevance to patient case: definitely relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: Imaging With a New Agent That Finds a Cancer Protein Called HER2

Summary: The purpose of this study is to test if an imaging agent called Zr-DFO-pertuzumab that finds HER2 proteins can be used to take pictures of HER2-positive cancer.


Eligibility: Inclusion Criteria:
  -  Age 21 years or greater
  -  Any biopsy proven HER2-positive malignancy. ASCO guidelines will be used to define HER2-positivity for breast cancer. Similar guidelines will be used for other cancer types as appropriate.
  -  At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
  -  ECOG performance of 0-2
  Exclusion Criteria:
  -  Life expectancy < 3 months
  -  Pregnancy or lactation
  -  Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.

Relevance to patient case: not relevant
Patient case: 64-year-old male with gastric cancer; genetic feature: ERBB2 amplification

Clinical trial: The p53 Colorectal Cancer Trial

Summary: Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.


Eligibility: Inclusion Criteria:
  -  Metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an EGFR inhibitor if applicable.
  -  Tumor lesion suitable for biopsy
  -  Age >18 years
  -  Clinically or radiologically measurable tumor deposits according to the RECIST criteria
  -  WHO performance status 0-1
  -  Radiology studies (CT thorax/abdomen/pelvis) and echo cor and ECG must be performed within 28 days prior to registration.
  -  Before patient registration in the trial, written informed consent must be given according to national and local regulations.
  -  Blood test requirements:
  Neutrophils > 1.0 e9/L Platelets > 75 e9/L Bilirubin < 20 µmol / L. Serum creatinine < 1.5 x ULN
  Exclusion Criteria:
  -  Co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
  -  Known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution.
  -  Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  -  Pregnant or lactating patients cannot be included.
  -  Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
  -  Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.

Relevance to patient case: not relevant