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

Clinical trial: Comparison of Circulating Tumor DNA and Tumor Tissue DNA by Targeted Sequencing in Non-Small Cell Lung Cancer

Summary: Conduct a prospective study to compare gene detection by ctDNA with tumor tissue DNA via targeted DNA sequencing in surgical NSCLC patients.

Detailed description: Previous studies have shown the feasibility of detecting mutation status by circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no clinical standard method has been established, and most previous studies were lack of prospective clinical data and aimed at advanced NSCLC.
  We plan to perform a prospective study including consecutive cases of NSCLC patients who underwent surgical treatments. Primary tumor and plasma samples were collected in each patients and gene mutation analysis were performed immediately after surgery. We utilized the targeted DNA sequencing with a next-generation sequencing (NGS) platform to detect driver somatic mutations in matched tumor DNA (tDNA) and plasma ctDNA samples with matched white blood cell (WBC) DNA as a control. A panel of genes were identified.

Eligibility: Inclusion Criteria:
  -  Patient who is confirmed primary lung cancer by frozen pathologic histology
  -  Both the fresh tissue tumor and plasma samples are collected for analysis
  Exclusion Criteria:
  -  Patients who received any treatment prior to resection
  -  Patients who have a history of malignancy
  -  Paraffin embedded section confirmed small cell lung cancer or unclassified carcinoma
  -  Tumor specimens where insufficient DNA

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

Clinical trial: Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

Summary: The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

Detailed description: Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.

Eligibility: Inclusion Criteria:
  1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
  2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
  3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
  4. 18-70 years old;
  5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
  6. agreed to participate in the study and sign an informed consent;
  7. without other severe comorbidities.
  Exclusion Criteria:
  1. lactating or pregnant patients;
  2. allergy to multiple drugs;
  3. with other severe comorbidities or psychological diseases;
  4. severe infection;
  5. participation in other clinical trials within the recent three months.

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

Clinical trial: Novel Detection System for Lung Cancer Curative Effect Monitoring

Summary: The purpose of this study is to investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.

Detailed description: Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21（L858R） mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation（T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.

Eligibility: Inclusion Criteria:
  1. Aged 18-85 years old;
  2. The diagnosis of lung cancer by pathological examination;
  3. At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
  4. People understand and are willing to accept the study, and sign the informed consent
  Exclusion Criteria:
  1. With severe hemorrhagic disease;
  2. Compliance is poor, can't cooperate with the visitor.

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

Clinical trial: Fibrocytes in Rheumatoid Arthritis, Asthma and Interstitial Lung-disease.

Summary: To study Fibrocytes in patients with Rheumatoid Arthritis, Interstitial lung disease and severe asthma and healthy controls.

Detailed description: Objectives: 1) To demonstrate that circulating CD45+ CD34+ CD11b+ cells can express Procollagen 1 and thereby show that these markers can be used to identify circulating fibrocytes. 2) To measure the levels of circulating CD45+, CD34+, CD11b+ cells in patients with RA, Fibrotic ILDs, severe asthma and in healthy controls (HC). 3) To compare the levels with number of peripheral blood mononuclear cells (PBMC) that differentiate to mature fibrocytes in vitro.
  Method: The CD45+, CD34+, CD11b+ cells from 4 patients were isolated by cell sorting, and stained for Procollagen. 30 patients (10 of each RA, fibrotic ILDs: IPF or non-specific interstitial pneumonitis (NSIP), severe asthma) and 10 HC were included. Current medication, disease activity, lung function and radiographic data were collected. In 100 µL of lysed blood cells were enumerated by flowcytometry. Further, PBMC were isolated and cultured for 5 days. Coverslips from two wells were stained and mature fibrocytes counted and reported as fibrocytes per 106 PBMC originally added to the well.

Eligibility: Inclusion Criteria:
  -  10 patient with rheumatoid arthritis.
  -  10 patients with interstitial lung disease (idiopathic pulmonary fibrosis or nonspecific interstitial pneumonia)
  -  10 patients with asthma
  -  10 healthy volunteers
  Exclusion Criteria:
  -  Unable to sign written informed consent to participate in the study.

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 Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Summary: Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.


Eligibility: Inclusion Criteria:
  1. Relapsed or refractory HER2 positive cancer.
  2. KPS>60.
  3. Life expectancy>3 months.
  4. Gender unlimited, age from 18 years to 80 years.
  5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.
  6. Acceptable organ function
  Hematology:
  -  Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
  -  White blood cell (WBC) (> 2000/mm^3).
  -  Platelet count greater than 50,000/mm^3.
  -  Hemoglobin greater than 9.0 g/dl.
  Chemistry:
  -  Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
  -  Serum creatinine less or equal to 3 times the upper limit of normal
  -  Total bilirubin less than or equal to 3 times the upper limit of normal.
  7. No other serious diseases(autoimmune disease, immunodeficiency etc.).
  8. Adequate cardiac function(LVEF≥40%).
  9. No other tumors.
  10. Patients volunteer to participate in the research.
  Exclusion Criteria:
  1. Allergic to cytokines.
  2. Uncontrolled active infection.
  3. Acute or chronic GVHD.
  4. MODS.
  5. Treated with T cell inhibitor.
  6. HIV affected.
  7. Other situations improper for the research.

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

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

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

Clinical trial: Blood-based Identification and Monitoring of Patients With ALK-translocated Lung Cancer

Summary: Genetic rearrangements in the Anaplastic Lymphoma Kinase (ALK) gene result in the creation of a variety of oncogenic fusion proteins that drive malignancy in a subset of non-small cell lung cancers (NSCLC) patients. Treatment with the ALK small tyrosine kinase inhibitor (TKI) crizotinib has produced remarkable results for ALK-positive patients, however the current diagnostic tests used in the clinic are not sufficiently detailed and require a tumor biopsy.
  The aim of this study is to use a new diagnostic test to detect ALK rearrangements using next generation sequencing, which will improve the diagnosis and treatment of ALK-positive NSCLC patients. Furthermore, this test will be performed on blood samples, making it minimally invasive for the patients. It is our believe that circulating tumor DNA (ctDNA) in blood can be employed as an easy accessible and comprehensive source of information to diagnose ALK-positive disease, but also as a means of monitoring patient response during treatment. Quantitation of the the amount of ALK rearrangement will give information about which patients benefit from treatment and when treatment is no longer effective. The project will be a multicenter study where blood samples will be collected every 6 weeks from patients treated at four major hospitals in Denmark.
  This study will benefit future patients with lung cancer, as it will improve both the monitoring and evaluation of their treatment. Monitoring patients during treatment will provide more knowledge of disease progression and the effect of ALK-TKI treatment, contributing to a greater selection of patients, who will respond to treatment. This will potentially allow effective treatment to continue longer than with conventional methods


Eligibility: Inclusion Criteria:
  -  Non-small cell lung cancer diagnosis
  -  Biopsy-verified ALK-translocation
  Exclusion Criteria:
  -  Patients were it is not possible to retrieve a biopsy
  -  Patients with squamous cell carcinoma

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

Clinical trial: Doctor-Patient Communication in Lung Cancer Care

Summary: The purpose of this study is to better understand communication between patients with lung cancer and their doctors. The investigators are also interested in patient's perceptions of the quality of communication with his/her doctor and how these perceptions may impact patient outcomes. The doctor is participating in this study and has given us permission to approach his/her eligible patients for study participation.


Eligibility: Inclusion Criteria:
  -  Patients with confirmed lung cancer diagnosis or mass suspicious of lung cancer seen at MSK within past 0-3 months at time of consent as per clinician report and/or EMR
  -  Lung cancer treatment plan at MSK to include surgery, chemotherapy, radiation and/or immunotherapy within three months of the time of consent
  -  Participating physician approves his/her patient's participation in this study per physician report.
  -  Former (at least 100 cigarettes in lifetime and quit more than 30 days prior to enrollment) or current smoker (lifetime smoker who reports cigarette smoking within the past 30 days) as per self report or EMR;
  -  English fluency (determined through EMR or clinician report), as we do not have the resources to translate the consultations from other languages or the surveys to other languages;
  -  Patients must 18 years old or older
  Physician Inclusion Criteria:
  -  An MSK attending physician (radiologists, medical oncologists, and surgeons), who is a member of the Thoracic Disease Management Team currently treating thoracic patients at MSK as per self report
  Exclusion Criteria:
  -  Patient unable to comply with study procedures as determined by principal investigator.
  Physician Exclusion Criteria:
  -  Inclusion on protocol face-page (e.g., Bernard Park, MD)

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

Clinical trial: Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?

Summary: Not significantly increased survival in T/T


Eligibility: Inclusion Criteria:
  -  NSCLC with spinal metastasis
  Exclusion Criteria:
  -  brain metastasis and expected survival < 3 months

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

Clinical trial: Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
  The Compassionate Use Programme will also provide additional safety information on gilotrif use.


Eligibility: Inclusion Criteria:
  1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
  2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
  3. No further treatment option is available.
  4. Male and female patients age ≥18 years.
  5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
  Exclusion Criteria:
  1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
  3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
  4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
  5. Bilirubin ≥1.5 mg/dl
  6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
  7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
  8. Pregnancy or breast feeding.
  9. Pre-existing Interstitial Lung Disease (ILD).
  10. Patients suitable to be included into afatinib clinical trials

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

Clinical trial: Perfusion CT Imaging in Lung Cancer With SBRT

Summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility: Inclusion Criteria:
  -  Gender: male or female
  -  CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
  -  Patient will sign a consent form prior to study entry
  -  Lung cancer and lung metastases are biopsy proven
  Exclusion Criteria:
  -  Patients who are unable to give valid informed consent
  -  Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

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

Clinical trial: CANPOS: Predictive Biomarkers of Tumor Progression in Non-small Cell Lung Cancer

Summary: CANPOS is a non-interventional study aiming at evaluate at the time of initial surgery the value of new serum markers to predict the occurrence of metastases in patients with early-stage non-small cell lung cancer. This would represent a rational to develop personalized follow-up and prevention strategies


Eligibility: Inclusion Criteria:
  -  patients with a diagnosis or suspected for a diagnosis of lung cancer, non-small cell lung cancer
  -  age over 18 years
  -  patient naïve of any oncology treatment (excluding surgery alone) within the past 5 years
  -  patient who signed the informed consent by the study protocol
  Exclusion criteria were:
  -  any ongoing treatment for cancer
  -  any history of cancer within 5 years before the diagnosis of lung cancer
  -  any psychological, sociological or geographical conditions that would not allow the study follow-up

Relevance to patient case: not relevant