araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Chidamide in Combination With Carboplatin and Paclitaxel in Advanced Non-small Cell Lung Cancer

Summary: The purpose of this study is to evaluate the efficacy and safety of Chidamide combined with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer.

Detailed description: The study is to evaluate efficacy which includes the progression free survival (PFS), PFS at 6 months, objective response rate, duration of response rate, overall survival and time to progression, and safety which include adverse events, vital signs, laboratory tests, of the treatment of chidamide plus paclitaxel and carboplatin in patients with advanced non small cell lung cancer.

Eligibility: Inclusion Criteria:
  -  Patients with histology or cytology confirmed non-small-cell lung cancer,stage IIIb or IV. Newly diagnosed or relapsed after surgery but have not received systemic drug therapy.Adjuvant chemotherapy after surgery should have completed for more than one year at study entry.
  -  Aged 18~75 years
  -  Epidermal growth factor receptor (EGFR) mutation negative or EGFR status is unknown
  -  With at least one measurable lesion
  -  White blood cell count≥4×10^9/L,platelet count≥100×10^9/L and hemoglobin≥11g/L
  -  Life expectancy ＞3 months
  -  Eastern Cooperative Oncology Group performance status of ≤1 at study entry
  -  Women of childbearing age should have pregnancy test negative and would like to conduct birth control during the study
  -  Have signed informed consent
  Exclusion Criteria:
  -  Patients with clinically significant corrected QT interval prolongation, or ventricular tachycardia,or auricular fibrillation, or ≥Grade 2 sino-auricular heart-block,or ≥Grade 3 atrioventricular block,or myocardial infarction within one year, or congestive heart failure,or patients with symptomatic coronary disease which need to be treated by drug
  -  The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10mm during diastolic period
  -  Organ transplant patients
  -  Patients with active bleeding or new thrombotic diseases
  -  Patients with body temperature ＞38.5℃ for more than 3 days
  -  Total bilirubin ＞1.5 fold of upper limit of normal (ULN), ALT/AST＞1.5 fold of ULN or serum creatine ＞1.5 fold of ULN
  -  Patients with symptomatic brain-metastasis
  -  Pregnant or lactating women
  -  Patients with mental disorder

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

Summary: Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Detailed description: Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Eligibility: Inclusion Criteria:
  -  Clinical diagnosis of malignant ascites or malignant pleural effusion
  Exclusion Criteria:
  -  Non-malignant ascites or pleural effusion

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

Summary: This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.


Eligibility: Inclusion Criteria:
  -  Age >=18 years
  -  For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
  -  For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC
  -  For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
  -  Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
  -  Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1
  -  Life expectancy >=12 weeks
  -  Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
  -  Adequate hematologic and end organ function
  -  Use of highly effective form of contraception
  Exclusion Criteria:
  -  Prior anti-cancer therapy
  -  Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
  -  Known significant hypersensitivity to any components of study treatment
  -  Grade >=2 peripheral neuropathy
  -  Type 1 or Type 2 diabetes
  -  Grade >=2 hypercholesterolemia or hypertriglyceridemia
  -  Congenital long QT syndrome
  -  Active congestive heart failure or ventricular arrhythmia

Relevance to patient case: possibly relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of Gene Expression Profiling and Immunological Mechanism Affects the Response of Immunotherapy

Summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor presenting malignant cavity effusion after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
  2. Malignant cavity effusion from cancer patients is obtained through puncture and is centrifugalized to get supernatant fluid and enrich cancer cells before and after the therapy.
  3. The enriched cancer cells which are flash frozen, as well as the supernatant, are stored at -80°C until processing.
  4. The T-Cell Receptor/B-Cell Receptor gene expression in cavity effusion is detected by micro-array to explore the mechanism that DC-CIK immunotherapy controls the malignant cavity effusion.
  5. Statistical analysis is performed using unsupervised hierarchical cluster.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed with malignant tumor and malignant cavity effusion.
  2. An Eastern Cooperative Oncology Group（ECOG）performance status of 0-2.
  3. Normal cardiac, hepatic, renal and bone marrow functions.
  4. Life expectancy >3 months.
  5. Not receive other anti-tumor treatment.
  6. Not receive chemotherapy in pleural and abdominal cavity.
  Exclusion Criteria:
  1. Previous history of other malignancies.
  2. Serious or uncontrolled concurrent medical illness.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Characterization of Peripheral Muscle Function in Patients With Non-small-cell Lung Cancer

Summary: Rationale: With 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. Patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. This syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. However, despite the importance of cachexia in lung cancer, its mechanisms ans its relation with muscle function and effort tolerance are still unknown.
  Aim: To explore muscle function, signaling pathways and its relationship to impaired functional capacity of patients with non-small-cell lung cancer(NSCLC); depending of whether they have cachexic state at diagnosis.
  Methods: This study will be conducted at the Institut universitaire de cardiologie et de pneumologie de Québec. 56 patients newly diagnosed of NSCLC will be recruited and separated whether or not they have a cachexic state. The evaluation will need two visits separated by 5 days.
  During the evaluation the following tests will be done:
  -  Anthropometric measures
  -  Level of daily physical activity
  -  Pulmonary function test
  -  Maximal incremental cardiopulmonary exercise test on ergocycle
  -  Endurance test on ergocycle
  -  Muscle function tests
  -  Magnetic stimulation
  -  Quadriceps biopsy


Eligibility: Inclusion Criteria:
  -  Men and women with a primary lung cancer diagnosis
  Exclusion Criteria:
  -  Already have undertaken surgery, chemotherapy or radiotherapy treatment
  -  Having an other cancer in the last five years
  -  Taking anticoagulation therapy

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: CT in Diagnosing Patients With Lung Cancer

Summary: This clinical trial studies computed tomography (CT) in diagnosing patients with lung cancer. Diagnostic procedures, such as CT, may help find and diagnose lung cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. Conduct a prospective clinical imaging study to quantify the amount of inter- and intra-physician contouring variability on four dimensional (4D) CT, active breathing control (ABC) CT, free breathing CT, and free breathing and ABC cone beam (CB)CT.
  II. Quantify the magnitude and distribution of target and organ at risk volume variations between the different imaging modalities.
  III. Determine dosimetric changes related to contouring variations for tumor and normal tissue.
  OUTLINE:
  Patients undergo conventional free breathing CT, 4D CT, ABC CT, ABC CBCT, and free breathing CBCT before undergoing radiation therapy.

Eligibility: Inclusion Criteria:
  -  Measurable disease on CT scan
  -  Patients with lung cancer visible on CT who are scheduled to receive external beam radiation treatment will be eligible for this study
  -  Patients must be able to perform ABC procedures
  Exclusion Criteria:
  -  Patients requiring continuous supplemental oxygen due to the requirement of spirometry during all imaging studies
  -  No vulnerable populations will be enrolled (prisoners, children, pregnant females or institutionalized individuals)
  -  Women of childbearing potential will undergo a pregnancy test

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

Summary: To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Detailed description: 1. The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) .
  2. Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing.
  3. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。
  4. Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy.
  5. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Eligibility: Inclusion Criteria:
  -  histologically confirmed with malignant tumor;
  -  Age: 18-80 years;
  -  an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  -  At least one measurable lesion according to the RECIST criteria;
  -  Adequate bone marrow, cardiac, liver, and renal function;
  -  Life expectancy ≥2 months;
  -  Not received other anti-tumor treatment
  -  Informed consent signed
  Exclusion Criteria:
  -  previous history of other malignancies;
  -  Uncontrolled central nervous system metastases;
  -  Serious or uncontrolled concurrent medical illness.

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors

Summary: This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.

Detailed description: This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.

Eligibility: Inclusion Criteria:
  1. Patients with the following indications:
  i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
  -  For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
  -  For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
  2. ECOG Performance Status of 0-2
  3. Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
  4. Willingness and ability to comply with all study procedures
  5. Written informed consent obtained prior to any screening procedures
  6. During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: the Quality of Life Assessment of Lung Cancer Patients in China

Summary: The goal of this study is assess the quality of life of advanced non-small cell lung cancer (NSCLC) patients who are undergoing first-line chemotherapy, analyze the current status and tendency of quality of life (QOL). The method is to use the Functional Assessment of Cancer Therapy-Lung (FACT-L) scales, assess the quality of life before the chemotherapy, after 1st cycle of chemotherapy and after 2nd cycle. After 3 time-points, investigators analyze all the subscales and constructs of FACT-L. The assumption is the quality of life will be better after 2 cycle of chemotherapy.

Detailed description: 1. Lung cancer is the most deadly cancer in the world, 85% lung cancer are non-small cell lung cancer (NSCLC). The quality of life of NSCLC patients become more and more important, because of most NSCLC is incurable.
  2. The recruitment will take place in 20 center all over the country and 500 patients will enrolled.

Eligibility: Inclusion Criteria:
  -  age: >18 and <75 years old
  -  pathological or cytological diagnosis confirmed advanced non-small cell lung cancer
  -  Eastern Cooperative Oncology Group Performance Status: 0-2
  -  have never receive any kind of anti-cancer chemotherapy
  -  agree to regularly assessment of quality of life
  -  sign the informed consent form
  Exclusion Criteria:
  -  Currently attending any antitumor drug clinical trials
  -  Pregnancy or breast-feeding women
  -  Currently receiving anti-tumor chemotherapy, or received any antitumor chemotherapy previously.
  -  not suitable to participate in this test

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

Summary: The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

Detailed description: The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

Eligibility: Inclusion Criteria:
  -  Non-suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung nodule lesion in the chest (based on local CT result);
  4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  -  Suspected lung cancer group (600 cases)
  1. Aged 40 to 75 years;
  2. Male smoker (≥400 cig/year), female smoker or non-smoker;
  3. Visible lung cancer lesion in the chest (based on local CT result);
  4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.
  Exclusion Criteria:
  -  Histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion;
  -  Already treated by chemotherapy or surgery

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Analysis of Plasma Tumor DNA in Lung Cancer Patients

Summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in <50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility: Inclusion Criteria:
  -  Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
  -  Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
  -  Patients must have given written informed consent
  Exclusion Criteria:
  -  Patients who refuse the blood samplings

Relevance to patient case: not relevant
Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.


Eligibility: Inclusion Criteria:
  -  Advanced NSCLC
  -  EGFR mutation or six months or longer benefit from EGFR TKIs
  -  Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
  -  Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.
  Exclusion Criteria:
  -  Inability to take oral drugs

Relevance to patient case: not relevant