araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: TrasGEX™: Dose Escalation Study

Summary: This is a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response will also be evaluated.


Eligibility: Main Inclusion Criteria:
  1. Signed written informed consent granted prior to initiation of any study-specific procedures;
  2. Male or female patients of ≥18 years of age;
  3. ERBB2 (HER-2) gene amplification or ERBB2 overexpression
  4. Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
  5. No anti-tumor therapy of proven benefit available at study enrollment;
  6. Life expectancy of >=3 months;
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
  8. Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
  9. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
  and
  Main Exclusion Criteria:
  1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
  2. Major surgery within four weeks of the first dose of TrasGEX™;
  3. Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
  5. History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
  6. History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
  7. Left ventricular ejection fraction <50%;
  8. Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
  9. Pregnancy or lactation; and
  10. Concurrent uncontrolled significant illness

Relevance to patient case: possibly relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Mindfulness for Lung Cancer Patients and Partners

Summary: The aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.

Detailed description: Receiving a diagnosis of cancer is a major cause of distress and is usually characterized by anxiety and depression. Compared to patients with other cancer diagnoses, patients with lung cancer report higher levels of distress, which probably can be explained by the poor prognosis. At the time of diagnosis, lung cancer is often locally or systematically advanced and 5-year survival is only 15 percent.
  Mindfulness based stress reduction (MBSR) is a recently developed psychological intervention that appears to be promising in terms of reducing psychological distress in cancer patients. It consists of 8 weekly group sessions in which formal and informal mindfulness practices are practiced. As most of the earlier studies have been conducted in patients with breast cancer, it is important to examine the effectiveness of this approach in patients with other types of cancer, such as lung cancer. Furthermore, a diagnosis of cancer is not only highly distressing for the patient but also for the partner and family.
  In this study, the (cost)effectiveness of MBSR compared with treatment as usual will be investigated in 110 patients with lung cancer and 110 partners.

Eligibility: Inclusion Criteria:
  -  Cytologically or histologically proven non-small cell lung cancer and small cell lung cancer.
  -  Patients can participate after lung cancer diagnosis, from start of treatment or after treatment.
  -  Sufficient understanding of Dutch language.
  Exclusion Criteria:
  -  Former participation in MBSR or MBCT course.
  -  Current psychological treatment by psychologist or psychiatrist.
  -  Cognitive impairments hampering participation in MBSR and completion of questionnaires.
  -  Physical impairments prohibiting participation in MBSR training.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study

Summary: To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.

Detailed description: A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer

Eligibility: Inclusion Criteria:
  -  18~70 year old, KPS score >50 points, estimate survival > 3 months;
  -  Primary lung cancer patients after chemotherapy or radiation therapy;
  -  Primary lung cancer patients after targeted therapy;
  -  Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
  -  Primary lung cancer recurrence or surgery can't complete resection;
  -  Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
  -  No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
  -  Patients Voluntary attempt, and informed consent.
  Exclusion Criteria:
  -  History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
  -  Cachexia; or other deadly diseases;
  -  Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
  -  Active infection;
  -  Pregnant or lactating women
  -  At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
  -  Now or recently will join another experimental clinical study ;
  -  Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Conservative Surgery With or Without Axillary Lymphnode Removal in Treating Women With T1N0 Breast Cancer

Summary: Rationale
  Axillary surgery is still fundamental part of breast cancer (BC) management for adjuvant treatment planning.
  Purpose
  Randomized phase III trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage I breast cancer.
  To determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

Detailed description: OBJECTIVES:
  To compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (QUAD) vs. quadrantectomy alone (QU)) followed by adjuvant treatment.
  To plan no adjuvant therapy vs. adjuvant therapy (eA+CMF+TAM regimen) based on a biological panel of the primary tumor in the QU group (defined as good panel (GP) ( ER+, and up to one unfavourable features (G3, Her2+++, Laminin Receptor+) or bad panel (BP)(ER-, or ER+ and more than one unfavourable features), whereas in QUAD group based on good factor ( N-, ER+ and GI-II disease (GF)) or bad factor ( N+ or GIII or ER- disease (BF)).
  To determine the relationship between the biological variables (hormone receptor status, grading, Laminin receptor, and c-erbB2) and the clinical outcome of the disease in these patients.
  OUTLINE This is a randomized unicenter study. Patients are randomized to 1 o 2 treatment arms.
  Arm 1: patients undergo conservative surgery with axillary lymphnodes removal Arm 2: patients undergo conservative surgery without axillary lymphnodes removal Post-operative adjuvant strategy was previously described.
  Patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter.
  PROJECT ACCRUAL 600 patients will be accrued for this study over 4 years
  ELIGIBILITY Ages eligible for study: 18-65 years Genders eligible for study: female

Eligibility: Inclusion Criteria:
  -  women with T1N0M0 invasive breast cancer
  -  18-65 years
  Exclusion Criteria:
  -  bilateral breast cancer
  -  no other prior or concurrent malignancy except basal cell carcinoma

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Icotinib Combined With Whole Brain Radiotherapy in Treating Multiple Brain Metastases From Non-Small Cell Lung Cancer

Summary: The aim of this study is to explore the efficacy and toxicity of icotinib combined with WBRT in treating patients with multiple brain metastases from NSCLC.

Detailed description: Brain metastases occur in 25-40% of patients with non-small cell lung cancer (NSCLC). It is one of the primary reasons resulting in treatment failure and the death. Whole-brain radiation therapy (WBRT) is the standard approach to the treatment of multiple brain metastases from NSCLC. Regardless of the treatment of brain metastases by WBRT combined with systemic chemotherapy,outcomes of NSCLC with brain metastases are still very poor. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from NSCLC. Icotinib shows nearly the same effect as gefitinib in advanced NSCLC patients failed with chemotherapy.

Eligibility: Inclusion Criteria:
  -  Cytologic or histological diagnosis of non-small cell lung cancer
  -  Patients with disease progression after systemic chemotherapy with two-drug combination regimens that includes a platinum agent or patients with EGFR mutation status who have not been treated
  -  Patients are diagnosed with multiple brain metastases for the first time in 4 weeks
  -  Diagnosis of brain metastases is made based on Magnetic resonance imaging (MRI).
  -  Doctors consider the patient will benefit from WBRT
  -  No prior brain radiotherapy
  -  ECOG performance status 0-2
  -  age:18-75 years
  -  Neutrophil count ≥1.5×10 to the 9th power/L and platelets≥100×10 to the 9th power/L. hemoglobin ≥90 g/L
  -  Hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) Alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 2.5 times ULN (or less than or equal to 5 times ULN in case of known liver involvement)
  -  Renal: Serum Creatinine less than or equal to 1.5 times upper limit of normal (ULN)
  -  Patients with measurable brain metastases according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  -  Patients must sign an informed consent indicating that they are aware of the investigational nature of the study
  Exclusion Criteria:
  -  Prior brain radiation therapy
  -  Solitary brain metastasis according to Magnetic resonance imaging (MRI)
  -  Mort than 3 extracranial organs have metastatic lesions
  -  Prior invasive malignancy (skin basal cell cancer, carcinoma in situ of cervix are permissible).
  -  pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

Summary: The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  1. Men and women, 18 years or older, with histologically or cytologically-confirmed, Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) with tumor progression following at least one prior treatment regimen [(either chemotherapy or an Epidermal Growth Factor Receptor inhibitor (EGFR)] for advanced disease. There is no restriction on the number of prior treatment regimens allowed.
  2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 1.
  3. Adequate organ function.
  4. Adequate contraception (if appropriate).
  5. Consent to retrieve archival tumor tissue.
  6. Consent to repeated tumor biopsy (dose expansion phase).
  Exclusion Criteria:
  1. Prior systemic cancer-directed treatments or investigational drugs within 4 weeks or 5 half lives, whichever is shorter except erlotinib which may be continued with intervention in subjects allocated in Arm A.
  2. Symptomatic central nervous system metastases.
  3. Acute or chronic pancreatitis.
  4. Persistent diarrhea or malabsorption > Grade 2, despite medical management.
  5. Impaired cardiac function or significant cardiac disease.
  6. Diabetes on active treatment, fasting blood glucose > 126 mg/dL, (glycated haemoglobin) HbA1c > 6.5%.
  7. Known Human Immunodeficiency Virus (HIV), chronic hepatitis B or C infection.
  8. Prior treatment with an investigational dual target of ripamycin 1 (TORC1)/ target of ripamycin 2 (TORC2), Phosphatidylinositol 3-Kinase (PI3K), or protein kinase B (Akt) inhibitor. Prior treatment with analogs of rapamycin (rapalogs) is allowed.
  9. Major surgery < 2 weeks prior to starting study drugs. No specific wash out is required for radiotherapy. Subjects must have recovered from any effects of recent therapy that might confound the safety evaluation of study drug.
  10. Pregnant or breastfeeding, inadequate contraception.
  11. History of concurrent second malignancies requiring ongoing systemic treatment.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Tumor Markers in Lung Cancer: DCAMLK-1LK-1

Summary: DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.
  The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.

Detailed description: In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.
  Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.

Eligibility: Inclusion Criteria:
  -  >45 years of age
  Exclusion Criteria:
  -  Unable to provide informed consent

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Circulating Tumor Cells in Lung Cancer

Summary: TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)
  BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.
  PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).
  SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.
  STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.
  Duration of the inclusions: 54 months.
  Duration of the study: 66 months.
  PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.
  SAMPLE SIZE : 200 patients
  STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.


Eligibility: Inclusion Criteria:
  -  Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.
  -  Age ≥ 18 years.
  -  Measurable or evaluable disease according to RECIST criteria.
  -  Ability to sign informed consent.
  Exclusion Criteria:
  -  Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
  -  Prior chemotherapy, radiation or surgery for lung cancer.
  -  Inability to comply with study and/or follow-up procedures.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: Pulmonary Rehabilitation Before Lung Cancer Resection

Summary: This study seeks to study the effectiveness of a short mindfulness based pulmonary rehabilitation program prior to a surgical resection in patients with lung cancer and severe Chronic Obstructive Lung Disease (COPD).


Eligibility: Inclusion Criteria:
  -  Patient is scheduled to undergo a surgery for non small cell lung cancer
  -  Moderate to severe COPD
  -  Current or ex smoker of ten or more years
  Exclusion Criteria:
  -  Unable to perform exercise due to active cardiovascular, musculoskeletal or mental problems Poorly motivated to attend the rehabilitation sessions or receive randomization.

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: French National Observatory of the Patients With Non-small Cell Lung (NSCLC) and Molecular Testings

Summary: The French National Cancer Institute (INCa) support a 28 hospital platforms network for molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies (commercially available or through clinical trials).
  The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).

Detailed description: The French National Cancer Institute (INCa) support a 28 hospital platforms network for molecular testing of cancer patients. These platforms routinely assess a panel of biomarkers in order to speed up access of French cancer patients to targeted therapies (commercially available or through clinical trials).
  Regarding stage IV non-squamous NSCLC patients, 7 biomarkers are assessed including activating EGFR mutations, EML4-ALK translocation and EGFR T790M, KRAS, BRAF, HER2 and PI3KCA mutations. In 2012, up to 17 to 20,000 patients will be tested on this platform network.
  The objective of the BIOMARKERS-France study is to describe the epidemiological, clinical and molecular characteristics of these patients and their tumors and to assess the impact of these analyzes on their treatment (ie bio-guided therapy) as well as outcomes (response rate, progression free and overall survival).
  This study will collect, in a prospective way, data from a unique national cohort in order to guide future decisions regarding biomarker assessments (type? Number? Methods? Etc) in connexion with all the other research works currently ongoing in France.

Eligibility: Inclusion Criteria:
  -  Advanced Non-small cell lung cancer (NSLC)
  -  Biomarkers analysis on hospital platforms
  Exclusion Criteria:
  - Histology other than NSLC

Relevance to patient case: not relevant
Patient case: 49-year-old female with lung cancer; genetic feature: ERBB2

Clinical trial: 18F FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Summary: The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. We will assess the uptake of this novel radiopharmaceutical in subjects with breast cancer, lung cancer, glioblastoma multiforme (GBM) and other cancers requiring antiangiogenesis treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. Evaluate 18F FPPRGD2 PET/CT or PET/MRI for prediction and early assessment of response to anti-angiogenesis therapy in patients with non-small cell lung cancer (NSCLC), breast cancer, glioblastoma multiforme (GBM) and other cancers.
  OUTLINE:
  Patients undergo 18F FPPRGD2 PET/CT or PET/MRI at baseline, 1 week, and 6 weeks (or standard of care follow-up) and 18F FDG PET/CT at baseline and 6 weeks (or standard of care follow-up) .
  After completion of study imaging, patients are followed up at 12 months.

Eligibility: Inclusion Criteria:
  -  Provides written informed consent
  -  Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment
  -  Able to remain still for duration of each imaging procedure (about one hour)
  Exclusion Criteria:
  -  Pregnant or nursing

Relevance to patient case: not relevant