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

Clinical trial: Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Summary: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Detailed description: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Eligibility: Inclusion Criteria:
  -  Provision of signed, written and dated informed consent prior to any study specific procedures
  -  Male or female, aged 18 years or older
  -  Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  -  KRAS mutation positive tumour sample as determined by the designated testing laboratory
  -  Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy
  Exclusion Criteria:
  -  Mixed small cell and non-small cell lung cancer histology.
  -  Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
  -  Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  -  Other concomitant anti-cancer therapy agents excepts steroids
  -  Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  -  Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

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

Clinical trial: Discordant HER2/Neu Status of Breast Cancer.

Summary: The purpose of this study is to determine discordant HER2/neu status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Detailed description: HER2/neu status of primary breast tumor and axillary lymph nodes were tested by IHC staining. In the cases of equivocal result of IHC, FISH test were performed.
  The result of HER2/neu status between primary breast tumor and axillary lymph node were analyzed.

Eligibility: Inclusion Criteria:
  -  Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.
  Exclusion Criteria:
  -  Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.

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 Treatment Outcome and Toxicity in Non-small Cell Lung Cancer Patients Wither-irradiated to a High Dose for Recurrent Disease

Summary: As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation.
  Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in MAASTRO are unknown at present. This study will provide knowledge on benefit and risks of such a therapeutic approach.

Detailed description: MAASTRO clinic is a leader in the (individual) management of patients with lung cancer. This has resulted in major publications in the past on individualized (chemo)radiotherapy for (NSCLC) [van Baardwijk 2006 and 2010]. As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation is also given in curative intent, thus again using high doses of radiation.
  Publications on this topic are rare. Most reports address the results of palliative re-irradiation of NSCLC [Ebara 2007, Jackson 1987, Montebello 1993, Tada 2005]. The ones available on re-irradiation with curative intent used outdated techniques [Okamoto 2002, Wu 2003]. Only one recent publication has analyzed the results of 37 NSCLC patients of whom 9 were re-irradiated with at least 50 Gy using helical tomotherapy [Kruser in press].
  The results of radical re-irradiation applying highly conformal radiation techniques within MAASTRO are unknown. This study will provide knowledge on benefit and risks of such a therapeutic approach. Furthermore, it may provide enough evidence to initiate a Phase II/III clinical trial for re-irradiation of NSCLC patients with curative intent.

Eligibility: Patients with advanced stage non-small cell lung cancer treated to higher doses of irradiation (i.e. EQD2>50Gy) twice: in the primary and recurrent setting.

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, Hair and Lung Concentrations of Metals and Metalloids in Patients With Lung Cancer or Chronic Obstructive Pulmonary Disease

Summary: Prospective research to study the relationship between concentrations of metals/metalloids in blood, hair and lung tissue with the occurence of lung cancer or chronic obstructive pulmonary disease.


Eligibility: Inclusion Criteria:
  -  Patients of 18 to 75 years of age.
  -  Patients admitted for lung resection (either cancerous or non-cancerous) or lung transplant
  Exclusion Criteria:
  -  Patients with mental or physical conditions that prevent them giving their agreement for 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: Rapid Learning for Lung Cancer

Summary: A retrospective, data mining project that re-uses routine patient care data for decision support systems.

Detailed description: By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility: Inclusion Criteria:
  - Patients notes as suffering from lung cancer in at least one clinical data source.

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, 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: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Study of Psychopathological Characteristics of Patient Smoking in Thoracic Oncology

Summary: Persistent smoking after lung cancer has been the subject of medical, therapeutic and epidemiological publications for twenty years of research. Continued persistent smoking is all the more a problem for oncologists as there is evidence that smoking cessation, with lung cancer, gives therapeutic benefit. Quitting smoking can improve the response to treatments (chemotherapy, radiotherapy, surgery), quality of life and overall survival. However many patients refuse adhesion to tobacco cessation. Daily practice leads us to the hypothesis that adhesion differences aren't related to the denial of medical information, nor to resignation or to nicotine dependence. Patients who continue smoking seem to face a form of impossibility to wean. Cigarette seems to be felt as a part of their body in their narration and description of their body image.


Eligibility: Inclusion Criteria:
  -  Men and women aged 18 years or older
  -  Patient affiliated to a social security system
  -  Patient who has signed and dated informed consent, written before all procedures related to the study
  -  Patient who has received the results of the previous mandatory medical examination
  -  Patient who has been diagnosed with lung cancer, regardless of the histological type of the cancer
  -  Patient who maintains an active smoking at the time of inclusion
  -  Patient who has smoked at least one cigarette in the previous year of inclusion
  -  Patient who is being treated for lung cancer (surgery, chemotherapy, radiotherapy) and not another form of cancer
  -  Tobacco consumer's only by smoke inhalation
  -  Tobacco consumer's or tobacco associated with cannabis
  Exclusion Criteria:
  -  Major patient under guardianship or curatorship or maintenance of justice
  -  Patient deprived of his liberty or in an emergency situation
  -  Patient with a Performance Statut(OMS) higher than 2 and/or with a psychiatric disorder like " schizophrenia and other psychotic disorders " (DSM IV)
  -  A palliative care patient
  -  Patient who began smoking during his diagnostic examination or after the diagnosis of cancer
  -  A pregnant or breastfeeding woman
  -  Patient in an exclusion period

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

Clinical trial: Immune Response in Lung Cancer

Summary: This study is designed to evaluate the importance of the immune cells localization (distribution) between malignant tumor islets and surrounding stroma and to investigate the associations between these immune cells as well as cytokines and clinicopathological and prognostic factors of non-small cell lung cancer (NSCLC) patients.


Eligibility: Inclusion Criteria:
  -  Eastern Cooperative Oncology Group (ECOG) score of 0-1
  -  Patients with histologically documented non-small cell lung cancer
  -  Control group - patients without non-small cell lung cancer
  -  Written (signed) Informed Consent to participate in the study
  Exclusion Criteria:
  -  Any other malignancies within 5 years
  -  Any unstable systemic disease (including active infections, significant cardiovascular disease)
  -  Prior chemotherapy or radiotherapy
  -  Autoimmune disease
  -  Nursing or pregnant women

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 Roles of Age, Comorbidity, and Telomere Length in Lung Cancer Treatment and Prognosis

Summary: The investigators hypothesize that the age-adjusted telomere length in lung cancer patients before chemotherapy may be correlated to comorbidity status and predict outcome. The change of telomere length shortening after chemotherapy may relate to treatment side effect and treatment response.

Detailed description: Except chemotherapy, telomere shortening were also related to a variety of cellular stress, including hydrogen peroxide, UV, and x-irradiation, transforming growth factor-beta, overexpression of oncogenes such as Ha-Ras. The cellular stress induced telomere shortening and/or telomere dysfunction and promote accelerated senescence in normal and malignant cells. Oxidative stress, which presented in several chronic inflammatory diseases, such as atherosclerosis, coronary artery disease, and chronic obstructive airway disease, was also found to be correlated with telomere shortening.

Eligibility: Inclusion Criteria:
  1. Patients who are newly diagnosed as lung cancer and prepared for scheduled chemotherapy.
  2. The diagnosis is based on pathology via surgical specimen, or biopsy; or cytology via lung, lymph node aspiration or effusion study.
  Exclusion criteria:
  includes clinical diagnosis of lung cancer without pathology or cytology proving, combined with other type malignancy, and expected short survival time less than one month.

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

Clinical trial: Circulating Fibrocytes in Non-small Cell Lung Cancer.

Summary: The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Detailed description: Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  Exclusion Criteria:
  -  Combination of other malignancy.
  -  Age less than 20 years (not include 20 years).
  -  Pregnancy.

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 Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Summary: This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.


Eligibility: Inclusion Criteria:
  -  female patients, >=18 years of age, with locally advanced breast cancer.
  Exclusion Criteria:
  -  previous therapy for any invasive malignancy.

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

Clinical trial: Determinants of Intensity of Care of Lung Cancer Patients With Organ Failure

Summary: Investigators will evaluate determinants of the patients' care type : palliative, medical or intensive care. The place of patient or family on care's decision will be noticed. Investigators will evaluate 3 month-survival and patients' feelings (visit with a psychologist) according to type of care they benefited.

Detailed description: Two hundred patients have to be enrolled in 2 years in the Grenoble Teaching Hospital and in the Saint Louis hospital in Paris between November 2010 and November 2012. Each lung cancer patient with at least one organ failure, admitted in emergency, thoracic oncology or directly in ICU will be included.
  The objectives are to identify patients' characteristics associated with proposition for intensive care unit admission and those associated with the decision of intensive care unit admission.

Eligibility: Inclusion Criteria:
  -  lung cancer
  -  Organ failure
  Exclusion 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: Single Scope Staging of Lung Cancer With Endosonography

Summary: Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach).
  Objectives: main and secondary:
  1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone.
  2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach).
  Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA.
  Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled.
  Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.


Eligibility: Inclusion Criteria:
  -  (Suspected) NSCLC;
  -  Indication for mediastinal nodal assessment;
  -  Suspected mediastinal lymph nodes within reach of EBUS;
  -  Age 18 years or older;
  -  Clinically fit to undergo surgical resection of the lung tumor;
  -  Provision of a written informed consent;
  Exclusion Criteria:
  -  Mediastinal re-staging after neo-adjuvant treatment;
  -  Indication for EUS other than mediastinal staging, eg a for malignancy
  -  suspected left adrenal;
  -  Active malignancy with a life expectancy of less than two years;
  -  Former therapy for lung cancer (chemotherapy, radiotherapy or surgery);
  -  Technical contraindication for EBUS or EUS (eg, esophagus stenosis);
  -  Pregnancy;
  -  Inability to consent;

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

Clinical trial: Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

Summary: Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Detailed description: Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.
  Methods:
  A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

Eligibility: Inclusion Criteria:
  1. Diagnose malignant pleural effusions by:
  -  Diagnose malignant pleural neoplasms by histopathology
  -  Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
  2. Written informed consent
  Exclusion Criteria:
  1. <18years of age
  2. Expected survival <3 months
  3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
  4. Planned chemotherapy
  5. Pregnancy or breast-feeding (women of child-bearing potential)
  6. Not signed informed consent or non-compliance with treatment protocols

Relevance to patient case: not relevant