araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Low-dose Computed Tomography Screening for Lung Cancer in Relatives With Family History of Lung Cancer

Summary: Screening with the use of low-dose computed tomography (LDCT) reduces mortality from lung cancer. Relatives with family history of lung cancer are at increased risk of lung cancer compared to those without a family history in pooled analysis. A prospective trial using LDCT of lung to screen the relatives with family history of lung cancer is needed.

Detailed description: Investigators invited participants with family history to join in this study under the criteria of (1) relatives of the lung cancer patients; (2) age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old; (3) compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation. The participants with (1) proved lung cancer either with or without treatment, (2) presence of hemoptysis or history of remarkable lung fibrosis, (3) any other cancer history or (4) chest CT examination within one year would be excluded from the study.
  The study was planned to enroll 1000 participants from simplex families and 500 participants from multiplex families for lung LDCT screening. Multiplex family was defined as two or more family members with lung cancers, and simplex family as one family member with lung cancer.

Eligibility: Inclusion Criteria:
  1. relatives of the lung cancer patients;
  2. age older than 55 years old or age older than the age of onset of lung cancer proband if the family members were less than 55 years old;
  3. compulsory signing the consent agreement after understanding the purpose of study and the exposure of radiation.
  Exclusion Criteria:
  1. proved lung cancer either with or without treatment,
  2. presence of hemoptysis or history of remarkable lung fibrosis,
  3. any other cancer history or
  4. chest CT examination within one year

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Web-based Genetic Research on Lupus

Summary: The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Detailed description: Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Eligibility: Inclusion Criteria:
  -  diagnosed with lupus by a qualified physician.
  -  consents to have 23andMe (via a partner) contact the physician to obtain medical record information
  -  willing to submit a saliva sample for DNA testing and complete online surveys related to condition
  -  at least 6 years old (minors under 18 require parental consent to enroll)
  -  access to the internet
  -  resides in the United States
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Efficacy and Safety of Pyrotinib in Patients With HER2 Mutation Advanced Non-Small Cell Lung Cancer

Summary: Various driver gene mutations have been identified in lung cancer. Among them, human epidermal growth factor 2 (HER2) was identified in about approximately 2% of non-small cell lung cancers.Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced Non-small cell lung cancer.

Detailed description: This study is designed to evaluate the efficacy and safety of Pyrotinib in patients with HER2 positive advanced pre-treated Non-small cell lung cancer.
  To observe objective response rate (ORR) of pyrotinib in HER2 positive NSCLC. To observe Progression free survival （PFS）. To assess the overall survival (OS). To assess side effects. To evaluate quality of life. To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.

Eligibility: Inclusion Criteria:
  -  Aged ≥18 and ≤80 years.
  -  ECOG performance status of 0 to 1.
  -  Life expectancy of more than 12 weeks.
  -  At least one measurable lesion exists.(RECIST 1.1)
  -  Histologically or cytologic confirmed HER2 positive advanced Non-small cell lung cancer who failed prior therapies.
  -  Required laboratory values including following parameters:
  ANC: ≥ 1.5 x 10^9/L, Platelet count: ≥ 80 x 10^9/L, Hemoglobin: ≥ 90 g/L, Total bilirubin: ≤ 1.5 x upper limit of normal, ULN, ALT and AST: ≤ 1.5 x ULN, BUN and creatine clearance rate: ≥ 50 mL/min LVEF: ≥ 50% QTcF: < 470 ms
  -  Signed informed consent.
  Exclusion Criteria:
  -  Subjects with third space fluid that can not be controled by drainage or other methods.
  -  Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
  -  Less than 4 weeks from the last radiotherapy,chemotherapy,target therapy
  -  Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
  -  Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
  -  Receiving any other antitumor therapy.
  -  Known history of hypersensitivity to pyrotinib or any of it components. Ongoing infection (determined by investigator).
  -  History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
  -  Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
  -  Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
  -  Known history of neurological or psychiatric disease, including epilepsy or dementia.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Genomic Landscape of Ceritinib

Summary: The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase (ALK) rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression.

Detailed description: Further improvements in therapy can only be achieved with a better understanding of the genomic landscape of ALK rearranged non-small cell lung cancer (NSCLC), specifically at the time of disease progression following treatment with ALK inhibitors. Recently, secondary ALK mutations, L1196M and G1269A have been described in patients with acquired resistance to crizotinib. A small subset of ALK positive lung cancer patients who progressed after treatment with ceritinib had tumors available for molecular analysis. Secondary mutations found included G1202R, F1174C, and F1174V. While this is interesting, an unbiased genomic study (exome or whole genome sequencing) using massively parallel sequencing at the time of disease progression is critical to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. To the best of the investigators' knowledge, such a study has not yet been reported.
  The investigators believe the time is ripe now to comprehensively characterize genomic alterations using massively parallel sequencing technology of ALK driven adenocarcinoma of the lung to fully understand the clonal heterogeneity before therapy and fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance. A better understanding of genomic alterations through an unbiased comprehensive approach likely would lead to rationally designed therapy to augment response to ALK inhibitors.

Eligibility: Inclusion Criteria
  -  Diagnosis of metastatic stage IIIB/IV lung adenocarcinoma.
  -  Presence of known ALK gene rearrangement.
  -  Consented to HRPO# 201305031 ("Tissue and Blood Acquisition for Genomic Analysis and Collection of Health Information from Patients with Thoracic Malignancies, Suspected Thoracic Malignancies, or Mesothelioma") with an existing specimen prior to initiation of treatment with ceritinib.
  -  At least 18 years of age.
  -  Received treatment with standard of care ceritinib

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy for Early Stage Lung Cancer

Summary: Lungs are made up of individual lobes. When a lung cancer tumour is detected in one of these lobes, surgeons typically perform a Lobectomy. A Lobectomy is the surgery most commonly done to treat early-stage lung cancer and requires removal of an entire lobe of the lung, which removes a large amount of lung tissue For patients with small tumours saving as much healthy lung tissue as possible is important. Each lobe of the lung has smaller sections called segments. When a lung cancer is in one of these segments, it is possible to remove that segment, without removing the entire lobe. This surgery is called a segmentectomy. Compared to a lobectomy, a segmentectomy saves a larger amount of healthy lung tissue.
  With the advances in screening technology for lung cancer tumours, an increasing amount of very small lung cancer tumours are being found, and the demand for segmentectomy is increasing. A segmentectomy is a hard surgery to perform robotically because it is difficult to view the tissue lines that separate each segment within the lobe. As a result, it is difficult for the surgeon to see exactly which pieces of tissue should be removed. Because of these challenges, many patients having robotic surgery will have a lobectomy, even if a full lobectomy is not needed.
  Near-Infrared Fluorescence (NIF) using indocyanine green (ICG) fluorescent dye is a recent advancement in the robotic platform of robotic surgery. The surgeon will view the CT scan to determine which segment the tumour is located in. Once identified, the surgeon will isolate the segment by cutting off the blood supply to that segment. Then ICG will be injected into a vein. It is expected that the entire lung, except the isolated segment, which will remain 'dark' as it was isolated from blood supply, will fluoresce, giving off a green hue when viewed with the da Vinci Firefly camera. The surgeon will identify 'dark' segment, and will remove it. A pathologist will examine the excised tissue to ensure that the tumour was removed in its entirety. Once confirmed, the surgeon will end the procedure. If the pathologist determines that the segment removed did not contain the entire tumour, then the surgeon will perform a routine lobectomy. This ensures patient safety and confirms that all participants will have the entire tumour removed from their lung.


Eligibility: Inclusion Criteria:
  1. Age > 18 years
  2. Tumor size <3 cm
  3. Clinical Stage 1 Non-Small Cell Lung Cancer (NSCLC)
  4. CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.
  Exclusion Criteria:
  1. Hypersensitivity or allergy to ICG, sodium iodide or iodine
  2. Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

Summary: EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.

Detailed description: 1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.

Eligibility: Inclusion Criteria:
  -  NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
  Exclusion Criteria:
  -  liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: the"Fuzzing" Therapy of TCM to Improve the Survival Quality of Early-stage NSCLC by Intervening the CTCs

Summary: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells(CTCs) play a key role in the process of distant metastasis. The investigators' study will elaborate the clinical significance of CTCs intervented by Traditional Chinese Medicine(TCM) in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Detailed description: Metastasis is the leading cause of death in patients with lung cancer, and circulating tumor cells play a key role in the process of distant metastasis.In recent years, research results have shown that CTCs may become a emerging marker and new target in the treatment of lung cancer. The investigators' study will elaborate the clinical significance of CTCs intervented by TCM in lung cancer from the diagnosis and clinical staging,metastasis and recurrence, individual treatment and prognosis and so on, in order to provide a new direction for the treatment of lung cancer.

Eligibility: Inclusion Criteria:
  1. Complete resection was accepted in IIa ~ Ⅲa stage, and the pathological changes could confirmed as non small cell lung cancer patients;
  2. Patients receiving chemotherapy for the first time in 6 weeks after surgery;
  3. Age from 18 Years to 70 Years;
  4. The liver and renal function were normal,and no other disease.
  5. Patients compliance is good ang can understand the situation of this study and signed informed consent
  Exclusion Criteria:
  1. Patients without clear pathological diagnosis;
  2. The expected survival period is morn than 6 months;
  3. Patients with serious diseases such as heart, liver, kidney and hematopoietic system;
  4. Patients with pregnancy or lactation;
  5. Persons with a history of less control.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Summary: Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer
  The LuCa Biology and Outcome (BiO)-Project


Eligibility: Inclusion Criteria:
  -  Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
  -  Age ≥ 18 years. There is no upper age limit.
  Exclusion Criteria:
  -  Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  -  No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
  -  No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Relevance to patient case: not relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Retrospective Study About Treatment Strategy After First/Second Line EGFR-TKI Failure

Summary: This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.


Eligibility: Inclusion Criteria:
  -  Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
  -  Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
  -  Patients who take EGFR-TKI as first/second line therapy.
  Exclusion Criteria:
  -  Patients who has taken EGFR-TKI before.
  -  Patients who take EGFR-TKI as third or more line.
  -  Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
  -  The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
  -  Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.

Relevance to patient case: possibly relevant
Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

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