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

Clinical trial: A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

Summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

Detailed description: Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3, VEGFR 1-3, and PDGFR α/β. Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for stronger efficacy in those with genomic aberrancies of FGF or PDGF. Abnormalities in the FGF, VEGF, and PDGF-related genes are observed across lung cancer histologies.
  The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors. Specifically, patients with FGFR1-amplification appeared to derive particular benefit from lucitanib.
  Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF, VEGF, and PDGF genetic alterations.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
  -  Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3, VEGFA, or PDGFRα amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2, or FGFR3 activating mutation
  -  Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
  -  Eastern Cooperative Oncology Group (ECOG) of 0 or 1
  -  Measurable disease per RECIST 1.1
  -  Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
  Exclusion Criteria:
  -  Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
  -  Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
  -  Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
  -  Symptomatic and/or untreated central nervous system metastases
  -  Presence of another active cancer
  -  Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
  -  Pregnant or breastfeeding women

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

Clinical trial: Calypso-based Deep Inspiration Breath Hold (DIBH) Radiation Treatments of Lung Cancer

Summary: The purpose of this study is to test the use of Calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. The Calypso beacons are small devices that are implanted in the lungs, near the tumor. They are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. The investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.


Eligibility: Inclusion Criteria:
  -  Patients must have histologic proof of malignancy suitable for thoracic radiation therapy
  -  Patients planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or oligo-metastatic carcinoma to the lung.
  -  Age ≥ 18 years old
  -  KPS ≥ 60%
  -  Ability to hold their breath for >20 seconds for 5 times
  -  Patients who are able to tolerate flexible bronchoscopy
  -  Patients with life expectancy of at least 12 months
  -  Patients able to have bronchoscopic placement of Calypso as confirmed on a recent (within the past 8 weeks) CT scan.
  -  Patients who are able to comply with the protocol follow-up schedule.
  Exclusion Criteria:
  -  Patients unable to comply with instructions for DIBH
  -  Patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which Calypso Medical considers will interfere with the Calypso System's electromagnetic localization.
  -  Patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the Calypso System operation on these devices are unknown.
  -  Patients with clinically significant active infections.
  -  Patients with bronchiectasis in the region of the intended implantation sites.
  -  Patients with a history of hypersensitivity to nickel.
  -  Patients whose lung tumors are being monitored with MR imaging (MR imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders).
  -  Posterior lesions that would be >19cm distance from Calypso detector plate. Patients may be treated in the prone position in order to meet the required minimum distance.
  -  Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study.
  -  Patients who are deemed unable to safely undergo or tolerate flexible bronchoscopy
  -  Patients who are unable to tolerate anesthesia or sedation
  -  Patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation.
  -  Female patients who are pregnant or nursing

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

Clinical trial: Long-term Observation PMS for Afatinib

Summary: In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).


Eligibility: Inclusion criteria:
  - Patients with EGFR mutation-positive inoperable or recurrent NSCLC will be included.
  Exclusion criteria:
  - None

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

Clinical trial: The Impact of Lung Cancer-derived Fibroblasts on Mast Cells Activation

Summary: In addition to their role in allergic inflammation, mast cells are often found at the site of tumors. They have been attributed both to pro- and anti-tumorigenic roles depending on the tumor type. Secretion of mast cell mediators such as histamine, tryptase, fibroblast growth factor (b-FGF), vascular endothelial growth factor (VEGF) and interleukin-8 (IL-8) can enhance tumor growth and angiogenesis while TNF-a and heparin act as tumor suppressors.
  The non-small cell lung cancer constitutes the majority of cases of lung cancer. In lung cancer, mast cell numbers correlate with tumor angiogenesis and poor prognosis.
  In this work, we are interested to determine the factors in lung cancer microenvironment that attribute to mast cell activation. Beside the tumor cells themselves, the cancer microenvironment includes other cells such as fibroblasts. The fibroblasts arising from tumor stroma, called cancer-associated fibroblasts (CAFs), undergo activation, and have different feature compared to normal fibroblasts (NFs). In this work we are interested to determine whether CAF cells derived from lung tumors, together with the lung cancer cells, or microvesicles-derived from these cells, are able to stimulate mast cells to degranulate and/ or to release various cytokines and chemokines.
  For this propose, during surgery of patients with lung cancer, we will take unnecessary sample from the cancer and from normal area for purification of CAF or normal fibroblast cells. Those cells will be co-cultured with both lung cancer cell line (A-549) or microvesicles-derived from these cells, and human mast cell line (LAD2). Supernatants will be collected for determine degranulation and cytokine release from these mast cells.


Eligibility: Inclusion Criteria:
  Patient with non small cell lung carcinoma
  Exclusion Criteria:

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

Clinical trial: Ethaselen for the Treatment of Thioredoxin Reductase High Expression Advanced Non-small Cell Lung Cancers

Summary: Thioredoxin reductase plays an critical role in lung cancer patients, in vitro study showed that, ethaselen, specific inhibitor of thioredoxin reductase, could inhibit lung cancer cell growth and induce apoptosis. In China, phase 1 clinical trials of ethaselen showed that 1200 mg dose ethaselen could be well tolerated, in pre-clinical study we found that, approximately 50% non-small cell lung cancers harbored high thioredoxin reductase expression(IHC result ++ or +++), phase 1a/b of ethaselen had finished in 2008, the result showed that 1200mg ethaselen per day was safety and tolerated by Chinese malignant tumor patients.In pre-clinical research, our group found that, elevated of thioredoxin reductase activity was associated with the expression of thioredoxin reductase tested by immunohistochemistry, which means high expression of this enzyme may be a favourite predicted factor of ethaselen, the specific inhibitor of thioredoxin reductase.

Detailed description: This phase 1c study will include patients pathologic diagnosis advanced non-small cell lung cancer who had received more than two lines standard treatment, according to NCCN Non-small cell lung cancer guideline, there were no standard treatment scheme for these patients. Approximately 40 patients will be included in the study, patients will received oral ethaselen dispersible tablet, 600 mg bid dose, primary endpoint of this study is 6 week disease control rate(DCR, CR+PR+SD), secondary endpoints include progression free survival(PFS), overall survival(OS), quality of life(QOL) and drug safety.

Eligibility: Inclusion Criteria:
  -  advanced non-small cell lung cancer, stage IIIB/IV who had received more than 2 standard treatment scheme
  -  18-75 years old, anticipate overall survival more than 3 months, ECOG 0-2
  -  within 4 weeks, not receive chemotherapy, radiotherapy or surgery
  -  HB≥90g/L； ANC ≥1.5×109/L；PLT ≥80×109/L
  -  EGFR/ALK mutation negative
  -  immunohistochemistry test of cancer tissue showed ++ or +++ of thioredoxin reductase
  -  brain metastasis without symptoms
  Exclusion Criteria:
  -  according to NCCN non-small cell lung cancer guidelines (2014 v3), there were standard treatment scheme for the patients
  -  pregnancy or breast-feeding women
  -  any serious disease which could not be controled
  -  urine protein≥++, or 24h urine protein＞1g
  -  received any anti-cancer treatment within 4 weeks

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

Clinical trial: Screening for Early Lung Cancer in Shanghai, China

Summary: Imaging procedures including chest X-ray and low-dose computed tomography may be effective in lung cancer early detection. Yet it is unknown whether low-dose computed tomography combined with computer aided detection （CAD) is more effective than LDCT in screening of early lung cancer.

Detailed description: The randomized clinical trial is to investigate and compare the effectiveness of CAD-guided low-dose computed tomography and low-dose computed tomography in lung cancer screening for community individuals in Shanghai, China. Thus, an imaging protocol which can detect early lung cancer in asymptomatic high risk patients will be proposed.

Eligibility: Inclusion Criteria:
  -  Age of 55 to 74 years; smoking history of at least 30 pack-years; and if former smoker, have quit within 15 years
  -  Age 50 or older ,20 or more pack-year history of smoking, and one additional risk factor (occupational exposure, residential radon exposure, cancer history, family history of lung cancer, history of lung disease)
  -  Age 35 and one additional risk factor
  -  Ability to accept LDCT examination and sign informed consent form
  Exclusion Criteria:
  -  Individuals with any symptoms suggestive of lung cancer （e.g., vigorous coughing, chest pain, weight loss, blood-stained sputum）
  -  Individuals with acute pulmonary abnormalities or those in poor health conditions or those have metallic implants or devices in the chest or back will be excluded due to the potential impact on the results as well as difficulty of acquiring the images.
  -  Pregnant women

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

Clinical trial: Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

Summary: The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.


Eligibility: Inclusion Criteria:
  Lung cancer:
  For patients participating in Part A (initial testing) and Part B (serial testing):
  -  Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy.
  -  Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory.
  -  ≥ 18 years of age
  Specific to patients participating in Part B (serial testing):
  -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
  -  Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory.
  -  Must be within 3 months of their diagnosis of metastatic lung cancer.
  -  Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol.
  Colorectal Cancer:
  For patients participating in Part A (initial testing) and Part B (serial testing):
  -  Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy.
  -  Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment).
  -  >18 years of age
  Specific to patients participating in Part B (serial testing):
  -  Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
  -  Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory.
  -  Must be within 3 months of their diagnosis of metastatic colorectal cancer.
  Exclusion Criteria:
  lung cancer and colorectal cancer
  -  Comorbidities that would prohibit or make serial urine collection difficult or impossible

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

Clinical trial: Non Invasive Detection of Lung and Breast Cancer by Odor Signature

Summary: The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology enables a high level of sensitivity and provides users with a quick lab response and a simple yes or no answer.
  The aim of this study is to contribute and detect the patient at the earliest possible stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a promising approach towards future possible lung and breast cancer screening method.

Detailed description: Early detection of cancer can dramatically improve the survival chances. to date, there is no efficient diagnostic tool for detection of lung cancer in early stages. Regarding breast cancer, the common screening tool us mammography, which suffer from low sensitivity and high false positive. Thus, there is an urgent need for developing a screening tool for early stages lung and breast cancer.
  The sense of smell depends on the ability of specialized sensory cells of the nose to perceive volatile compounds (VOCs). Diseases such as infections and malignancies can be associated with changes in host metabolism, accompanied by production of different VOCs, and thus a different odor. Several studies have shown that different cancers secrete different VOCs, thus produce different smell.
  We have developed a system which uses biosensors that can scent the VOCs that lung and breast cancer cell produce, thus distinguish between healthy control and lung or breast cancer. These biosensors can detect low stages lung and breast cancer.
  Patients will supply urine samples and exhaled breath samples using a kit that we will supply. The samples will be shipped to our lab, where they will be processed and the VOCs will be separated from the head space of the samples. The biosensors will be exposed to the VOCs samples and will report whether the specific sample id cancerous (lung or breast) or not.
  The Data will be collected from all samples and statistical analysis will be calculated, in order to test the specificity and sensitivity of our biosensors to detect cancerous samples.

Eligibility: Inclusion Criteria:
  -  Diagnosed Lung Cancer patients
  -  Diagnosed Breast Cancer patients
  Exclusion Criteria:
  -  Cancer patients who were treated using chemotherapy
  -  Cancer patients who were treated using radiation
  -  Cancer patients who were treated using biological treatments
  -  Cancer patients who were treated with chemotherapy
  -  Cancer patients who were treated with any anti- cancer therapies
  -  Cancer patients who use drugs that affect the immune system

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

Clinical trial: Study of EGFR-TKI to Asymptomatic Brain Metastases of NSCLC

Summary: The purpose of this study is to determine whether EGFR-TKI can control the development of intracranial lesions in Non Small Cell Lung Cancer patients with asymptomatic brain metastases, and the difference in progression free survival between exon 19 and exon 21 mutations.

Detailed description: A open, positive control of phase II clinical trials, divided into selection period, treatment period and follow-up period , comply with the standard set of participants signed a written informed consent, according to different divided into 19 patients with EGFR mutations outside show son mutation group) and 21 extra show mutations, and according to the ECOG physical status, age, previous systemic treatments such as hierarchical analysis, regular follow-up and to assess efficacy, life care and safety.

Eligibility: Inclusion Criteria:
  1. at the age of 18 -70 years old, male or female
  2. the non-small cell lung cancer diagnosed by histopathology
  3. detected by ARMS to confirm that the EGFR sensitive mutant patients
  4. the existence of MRI diagnosis of intracranial metastatic head enhancement, and the presence of imaging evaluating lesions (according to RECIST1.1)
  5. have not received prior treatment of intracranial metastases, including radiotherapy, gamma knife, chemotherapy drugs
  6. no brain metastasis symptoms, including, increased intracranial pressure, no vomiting, ignoring the papillary edema, no headache, without hemiplegia, ignore things not clear, without epilepsy
  7. PS:0 or 1
  8. the expected survival time 3 months &gt;
  9. patients signed informed consent voluntarily
  Exclusion Criteria:
  1. 4 weeks before entering the group received operation or operation, the wound has not healed completely
  2. into group 2 weeks before receiving immune therapy or treatment of traditional Chinese Medicine
  3. serious cardiovascular diseases, including Department of internal medicine, uncontrolled hypertension, unstable angina, myocardial infarction history exists within the past June, severe arrhythmia or pericardial effusion
  4. serious infection, need intravenous antibiotic, antifungal or antiviral treatment
  5. before entering the group 4 weeks participated in any study drug clinical trial
  6. there are serious tumor invasion, oppression by the main bronchus or bronchial stenosis or obstruction, superior vena cava syndrome
  7. the existence of herniation of brain tumor apoplexy, epilepsy, and frequent
  8. suffering from a mental illness, poor compliance
  9. the researchers think that do not fit into the group of cases

Relevance to patient case: not relevant