araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

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: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Summary: This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Detailed description: Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both groups will be evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.

Eligibility: Inclusion criteria:
  1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
  2. Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1, FGFR2,or FGFR3
  3. RANO defined tumor progression by MRI in comparison to a prior scan
  4. Patients must have received prior external beam radiotherapy and temozolomide.
  Exclusion criteria:
  1. History of another primary malignancy
  2. Prior or current treatment with a FGFR inhibitor
  3. Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
  4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

Summary: To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.

Detailed description: This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.

Eligibility: Inclusion Criteria:
  -  Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients
  -  Performance status score ≤ 2
  -  Chest CT with measurable lesions
  Exclusion Criteria:
  -  Examination revealed any part of venous thromboembolism
  -  Chemotherapy regimens containing bevacizumab or Endostar
  -  Severe coagulopathy
  -  Active bleeding within two weeks

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Correlation Research of Thioredoxin Reductase in Lung Cancer

Summary: In pre-clinical study the investigators found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, so the investigators hypothesis that this is due to tumor cells loading of the patients, the enzyme activity may harbours huge difference between carcinoma tissues and para-carcinoma tissues in early staged non-small cell lung cancers, and after surgery, the enzyme activity may fall down to a normal level because of removing of tumor.

Detailed description: This is a cooperative research project in Thoracic Surgery Department and Medical Oncology Department of Affiliated Cancer Hospital of xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity using blood and lung cancer tissue and measure thioredoxin reductase messenger ribonucleic acid (mRNA) and protein expression using lung cancer and pericarcinomatous tissue in early staged(Ⅰ~ⅢA) non-small lung cancers, to study the correlations of thioredoxin reductase between blood and tissue. The secondary objectives are to measure the thioredoxin reductase activity between non small lung cancers and lung benign lesion patients to identify the difference between tumor and lung benign mass.

Eligibility: Inclusion Criteria:
  -  Pathologically proven staged(Ⅰ~ⅢA) non-small cell lung cancer or CT scan shows resectable lung mass
  -  Receive surgery in Thoracic Oncology department Hunan Tumor Hospital without contraindication of surgery
  -  Malignant tumor treatment naive（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before）
  -  Signed informed consent about providing blood and tissue for study
  Exclusion Criteria:
  -  Patients have received antitumor treatment
  -  Patients with contraindication of surgery or patients who need adjuvant chemotherapy with contraindication of chemotherapy
  -  Pregnant or breast feeding women

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Study of Use of CTC in NSCLC

Summary: The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients

Detailed description: Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.
  The use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients.

Eligibility: Inclusion Criteria:
  For subjects with lung malignancies:
  -  18 years of age and older
  -  Diagnosis of new or recurrent non-small cell lung cancer
  -  Awaiting treatment and follow up
  -  Have radiographic measurable metastatic disease that can be followed
  -  Be able to sign an IRB approved informed consent form
  -  Life expectancy greater than 12 weeks
  For subjects with COPD and without lung malignancies:
  -  18 years of age and older
  -  Diagnosis of COPD
  -  No current or prior malignancies (except squamous or basal cell carcinoma of the skin)
  -  Be able to sign an IRB approved informed consent form
  For Healthy Control Subjects (Dry Runs):
  -  18 years of age and older
  -  Has no current or prior malignancies (except squamous or basal cell carcinoma of the skin)
  -  Patients must sign an IRB approved informed consent form
  Exclusion Criteria:
  For subjects with lung malignancies:
  -  Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)
  -  ECOG performance status of 4
  -  Pregnant female (self-reporting)
  -  Cognitively Impaired
  -  Prisoner
  For subjects with COPD and without lung malignancies and Healthy Controls:
  -  Any other form of malignancy (except squamous or basal cell carcinoma of the skin)
  -  Pregnant female (self reporting)
  -  Cognitively impaired
  -  Prisoner

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: Biomarkers for Diagnosis of Lung Cancer

Summary: The study goal is to collect blood samples from individuals at risk for lung cancer in order to identify protein markers for diagnosis of lung cancer in the Chinese population.


Eligibility: Inclusion Criteria:
  -  Adults ≥ 18 years of age
  -  Patients referred to pulmonologists, oncologists, or thoracic surgeons for diagnosis of suspicious pulmonary nodules as either lung cancer or benign and undergoing bronchoscopic biopsy
  -  Patients will be enrolled if the result of the bronchoscopic biopsy is a diagnosis of NSCLC or benign pulmonary nodule
  -  Cases: Patients with untreated non-small cell lung cancer, i.e. primary lung adenocarcinoma or squamous cell carcinoma of early
  -  Computed tomography or X-Ray is available and shows a suspicious pulmonary nodule
  -  A biopsy or surgical resection to clarify the nature of the lung nodule is available (NSCLC or benign, including histological diagnosis) in both groups
  -  Controls: Patients must be available for a 6 month follow-up to confirm benign diagnosis
  -  A serum and plasma sample was collected prior to any treatment of the lung nodule beyond biopsy
  -  No other cancer diagnosis in the last 5 years excluding non-melanoma skin cancer
  -  Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.
  Exclusion Criteria:
  -  Prior treatment for lung cancer by chemotherapy or surgery (excluding biopsy)
  -  Patients with benign nodules who are not able or willing to have a 6-month follow-up visit to confirm benign diagnosis
  -  Diagnosis or treatment of other cancer in the last 5 years excluding non-melanoma skin cancer. In the judgment of the clinical investigator, patients who are likely to be non compliant or uncooperative during the study.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Summary: The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed breast adenocarcinoma.
  -  Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample.
  -  Prior first-line systemic therapy in the metastatic setting.
  -  Demonstrated progression of disease by radiological or clinical assessment.
  -  Female patient, aged ≥18 years old.
  -  Estimated life expectancy >3 months.
  -  Normal Left ventricular function
  -  Adequate haematological, hepatic and renal functions.
  -  For women with childbearing potential, a negative pregnancy test prior to initiation of the study drug and willingness to use an effective contraception.
  -  Ability to swallow oral capsules or tablets.
  Exclusion Criteria:
  -  More than two lines of chemotherapy with or without targeted therapy in the metastatic setting.
  -  Previous treatment with bevacizumab within 3 months of first dose of Investigational Medicinal Product.
  -  Active central nervous system metastases, cerebral oedema, and/or progressive growth.
  -  Patients with impaired cardiac function.
  -  Uncontrolled arterial hypertension
  -  Patients with history of thrombotic disorders or hereditary risk factors of thromboembolic events
  -  Serum potassium level below Lower Limit of Normal
  -  Uncontrolled hypothyroidism.
  -  Pregnant or breastfeeding women.

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

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: definitely relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

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: 57-year-old male with lung cancer; genetic feature: FGFR1

Clinical trial: A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases

Summary: Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms. It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer. Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB). This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.


Eligibility: Inclusion Criteria:
  -  Histologically or cytologically confirmed lung cancer or breast cancer at primary site
  -  Patient with inoperable brain metastases
  -  Female or male, ≥ 20 and < 65 years of age
  -  Karnofsky performance status (KPS) ≥ 70%
  -  Life expectancy ≥ 12 weeks
  -  Adequate organ function
  -  Willing and able to provide a written informed consent
  Exclusion Criteria:
  -  Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
  -  Male whose partner is planning to be pregnant
  -  Inability to swallow
  -  Meningeal carcinomatosis
  -  History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
  -  Prior use of temozolomide
  -  Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
  -  Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
  -  Current use of valproic acid
  -  Use of any investigational product within 4 weeks prior to the initiation of study treatment
  -  Patient with any condition or disease which is considered not suitable for this study by investigator

Relevance to patient case: not relevant
Patient case: 57-year-old male with lung cancer; genetic feature: FGFR1

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