araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Summary: This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

Detailed description: This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.
  After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:
  -  Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
  -  Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
  Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.
  The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.

Eligibility: Inclusion Criteria:
  Histological or cytological diagnosis of NSCLC;
  -  Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
  -  Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
  -  Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;
  -  No prior treatment for NSCLC is allowed;
  -  Adequate tissue in terms of quality and quantity for EGFR local testing.
  Exclusion Criteria:
  -  no adequate bone marrow function within 2 weeks prior to randomization
  -  no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
  -  no adequate renal function within 2 weeks prior to randomization
  -  known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
  -  known history of allergic reactions attributed to compounds of similar chemical or biological composition;
  -  history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

Summary: This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

Detailed description: Crizotinib is indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to provide access to an alternative oral formulation of crizotinib for those patients who are unable to swallow capsules.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject to approval by the sponsor).
  -  Inability to swallow crizotinib capsules, adult patients of whom must either have a feeding tube in place or have completed clinical evaluation of dysphagia without any reversible causes identified.
  -  At least 12 months of age (patients <12 months of age will be evaluated on a case by case basis and discussed with the sponsor).
  Exclusion Criteria:
  -  Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
  -  Adult patients who have been previously treated with crizotinib.

Relevance to patient case: definitely relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Functional Status in Patients Undergoing Curative Treatment for Lung Cancer

Summary: This trial investigates the impact of curative lung cancer treatment on functional status and exercise tolerance. Furthermore this trial investigates possible underlying causes and consequences of deconditioning.

Detailed description: Preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. The underlying mechanisms and impact of this change has not yet been investigated. In light of this, our trial will prospectively follow a convenience sample of 70 patients with lung cancer who are treated curatively. Patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy). The aims of the study are to
  1. Investigate the influence of curative treatment for lung cancer on functional and maximal exercise tolerance (primary outcome).
  2. Investigate the metabolic changes underlying changes in exercise tolerance during curative treatment for lung cancer (primary outcome).
  3. Investigate the relationship between changes in exercise tolerance, daily physical activity, pulmonary function and skeletal muscle function during curative treatment for lung cancer (secondary outcome).
  4. Investigate the relationship between changes in exercise tolerance and self-reported quality of life, functional status, feelings of anxiety and depression and symptoms during curative treatment for lung cancer (secondary outcome).
  5. Investigate the relationship between physical activity and exercise tolerance on one hand and comorbidities, hospitalisations and cancer-related and all-cause mortality on the other hand after curative treatment for lung cancer (exploratory outcome).

Eligibility: Inclusion Criteria:
  -  curative treatment for lung cancer
  Exclusion Criteria:
  -  presence of other neoplasms
  -  progressive neuromuscular and neurological diseases
  -  unstable cardiac disease
  -  pulmonary hypertension
  -  interstitial lung disease
  -  orthopedic conditions that significantly impair functional status
  -  mental or psychiatric disorders that impair the ability to comply with study procedures.
  -  a history of cerebrovascular accident with remaining functional consequences
  -  a history of lung cancer
  -  lack of knowledge of the Dutch, French or English language will be excluded

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: LIquid BIopsies in Lung Cancer (LIBIL)

Summary: The goal of this project is to create a biological collection of blood samples from patients with advanced stage IIIB/IV non-small cell lung cancer (NSCLC) with clinical annotations.


Eligibility: COHORT 1
  Inclusion Criteria:
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) regardless of the mutation status
  -  Inclusion at the time of diagnostic
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion Criteria:
  - Patients treated before their liquid biopsy
  COHORT 2 Inclusion criteria
  -  Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET) amplification, RET rearrangement.
  -  Inclusion at the time of diagnostic during follow-up or at relapse
  -  Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the institution with an available histopathological report
  -  Age ≥ 18 years
  Exclusion criteria
  - Patients treated before their liquid biopsy

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Tumor-specific T Cells in Lung Cancer

Summary: Non-small cell lung cancer is characterized by aggressive growth and treatment resistance. New approaches include immunotherapeutic strategies but spontaneous immune responses against tumor antigens remain unclear. The aim of this study is to characterize localization and frequencies of spontaneously induced memory T cells specific for a panel of tumor-associated antigens in peripheral blood and bone marrow of non-small cell lung cancer patients.


Eligibility: Inclusion Criteria:
  -  Patients with histology proven non-small cell lung cancer or a lesion suspicious of non-small cell lung cancer (lung cancer group)
  -  Healthy donors (control group)
  -  written informed consent
  Exclusion Criteria:
  -  Autoimmune disease
  -  Patients receiving immunomodulatory drugs, e.g. tacrolimus
  -  Prior malignancy
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

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: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Radiofrequency Ablation of Malignant Pulmonary Nodules

Summary: The objective of this study is to evaluate the outcomes of radiofrequency ablation in the treatment of patients with malignant pulmonary nodules（not exceed 3cm ）who are not suitable candidates for or refuse surgical resection.

Detailed description: Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique widely used to treat solid tumors. Patients with malignant pulmonary nodules will undergo a series of CT- guided percutaneous RFA procedures. During the procedures，percutaneous needles will be inserted into the target tissues under CT guidance，the needles deliver thermal energy and then destroy the tumors by causing coagulation necrosis via tissue heating. The purpose of this study is to assess the effectiveness and safety of RFA in pulmonary nodules （maximum tumor diameter ≦30 mm） was 10 mm apart from the big trachea, primary bronchi, esophagus, great vessels，heart and pleura. Preoperative and postoperative evaluations，including recent laboratory tests evaluated and imaging studies reviewed，will be performed both before and after the procedures.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed malignant pulmonary nodules.
  2. Patients refuse or are not suitable for surgical resections.
  3. 1-3 pulmonary nodules , with a maximum tumor diameter ≦30 mm.
  4. Minimum distance of nodules are at least 10 mm apart from the surrounding tissues as big trachea, primary bronchi, esophagus, great vessels，heart and pleura.
  Exclusion Criteria:
  1. Patients who has uncorrectable coagulation disorders, severe heart or pulmonary failure, or uncontrolled infections.
  2. With extensive extrapulmonary or intrapulmonary metastasis.
  3. Have taken anticoagulant as aspirin in one week.
  4. Target nodules nearby pleura or other important hilum and mediastinum structures.
  5. With metal implants are adjacent to the target tissues which will be covered with ablation area.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: A Sunscreen Based on Bioadhesive Nanoparticles

Summary: The initial focus of the study will be on safety, sun protection factor (SPF) characterization, and substantivity (duration of protection) studies. The primary outcome of the study will be to measure the sun protection factor (SPF) of a bioadhesive nanoparticles (BNP) formulation in 20-25 healthy volunteers with fair skin.

Detailed description: The purpose of this study will be to evaluate the duration of protection and efficacy of a novel bioadhesive nanoparticle sunscreen in 20-25 human volunteers.This technology makes sunscreens safer and longer-lasting by encapsulating UV sunscreen active agents in non-toxic nanoparticles. Strong preclinical data exists demonstrating the potential for improved safety, long-duration of retention, and increased effectiveness of this product.
  This innovative solution focuses on preventing damage caused by UV exposure through the use of a nanoparticle delivery vehicle. The bioadhesive feature of this technology enables longer protection. In addition, encapsulation of the UV filter in a bioadhesive nanoparticle (BNP) improves filter photo-stability, delays filter photo-degradation, and prevents reactive oxygen species (ROS) escape, thereby reducing the risk of cell damage and epidermal toxicity from UV filters.
  Furthermore, the bioadhesive feature of our technology eliminates penetration into deeper skin layers or into the blood, minimizing the potential side-effects of UV filters. It is believed that the translation of this technology will provide a longer-lasting, safer, more protective UV sunscreen.

Eligibility: Inclusion Criteria:
  -  Subjects must be in good health with minimal skin irregularities, as evaluated by a physical examination.
  -  The physical examination shall determine the presence of sunburn, suntan, scars, active dermal lesions, and uneven skin tones on the areas of the back to be tested. The presence of nevi, blemishes, or moles will be acceptable if in the physician's judgment they will not interfere with the study results. Excess hair on the back is acceptable if the hair is clipped or shaved.
  -  Subjects must fall into one of the following 3 Fitzpatrick Skin Scale categories:
  1. Always burns easily; never tans (sensitive)
  2. Always burns easily; tans minimally (sensitive)
  3. Burns moderately; tans gradually (light brown) (normal)
  Exclusion Criteria:
  -  Volunteers cannot have a history of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or melanoma).
  -  Volunteers cannot have a history of skin disease (such as psoriasis, exema, or vitiligo).

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

Summary: This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Detailed description: This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), MTD/RP2D (maximum tolerated dose/recommended phase 2 dose) and preliminary efficacy of DS-6051b will be evaluated.

Eligibility: Inclusion Criteria:
  -  Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
  -  An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  Exclusion Criteria:
  -  Previously had or currently has any of the following diseases:
  Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
  -  Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
  -  Severe or uncontrolled concomitant disease.
  -  Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Summary: Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

Detailed description: Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.
  Exclusion Criteria:
  -  ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR

Relevance to patient case: not relevant
Patient case: 71-year-old female with lung cancer; genetic feature: ROS1

Clinical trial: Perfusion CT Imaging in Lung Cancer With SBRT

Summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility: Inclusion Criteria:
  -  Gender: male or female
  -  CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
  -  Patient will sign a consent form prior to study entry
  -  Lung cancer and lung metastases are biopsy proven
  Exclusion Criteria:
  -  Patients who are unable to give valid informed consent
  -  Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

Relevance to patient case: not relevant