araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: A Study of Dacomitinib in Patients With Metastatic EGFR Mutant Lung Cancer Previously Treated With Osimertinib

Summary: The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.


Eligibility: Inclusion Criteria:
  -  Written informed consent
  -  Advanced biopsy-proven metastatic non-small cell lung cancer
  -  Somatic activating mutation in EGFR in a tumor biopsy
  -  Prior treatment with osimertinib with response followed by disease progression
  -  No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
  -  Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy after disease progression on osimertinib prior to study initiation
  -  Measurable (RECIST 1.1) indicator lesion not previously irradiated
  -  Karnofsky performance status (KPS) >/= 70%
  -  Age >/= 18 years old
  -  Ability to swallow oral medication
  -  Adequate organ function
  -  AST, ALT </= 3 x ULN
  -  Total bilirubin </= 1.5x ULN
  -  Creatinine </= 1.5x ULN OR calculated creatinine clearance >/= 60ml/min
  -  Absolute neutrophil count (ANC) >/= 1000 cells/mm3
  -  Hemoglobin>/=8.0 g/dL
  -  Platelets >/=75,000/mm3
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Any radiotherapy within 1 week of starting treatment on protocol.
  -  Any major surgery within 1 weeks of starting treatment on protocol.
  -  Any evidence of active clinically significant interstitial lung disease
  -  Continue to have unresolved > grade 1 toxicity from any previous treatment Treatment
  -  Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
  -  Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: NGS Combined With RNAseq on Tumor Immune Escape in NSCLC

Summary: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq

Detailed description: Study on the tumor immune escape in advanced non-small cell lung cancer patients with EGFR and ALK mutant negative by NGS combined with RNAseq. Detecting non-small cell lung cancer patient NGS and RNAseq data before first-line chemotherapy, after two cycles chemotherapy and after disease progression.

Eligibility: Inclusion Criteria:
  Non-small cell lung cancer patient First-line chemotherapy with platinum-based chemotherapy
  Exclusion Criteria:
  EGFR mutant positive Alk mutant positive

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: A Real World Study of Anti-PD-1/PD-L1 Antibodies for the Treatment of Advanced Solid Tumors

Summary: The study was designed to analyze the efficacy and safety of anti-PD-1/PD-L1 antibodies for the treatment of advanced solid tumors.

Detailed description: The study is a real-world study and the case records of patients with advanced solid tumors who visited Department of Medical Oncology, Chinese PLA General Hospital from 2015 to 2019 and received anti-PD-1/PD-L1 antibody therapy will be collected in this study. The medical data including patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, and so on will be extracted to analyze the effectivity and safety of anti-PD-1/PD-L1 antibodies and explore the prognosis-relevant factors of advanced solid tumors.

Eligibility: Inclusion Criteria:
  -  Pathologically or cytologically confirmed advanced solid tumors;
  -  Received anti-PD-1/PD-L1 antibody therapy.
  Exclusion Criteria:
  -  No specific exclusion criteria in this real world study.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: ALK Inhibitor in Metastatic Colorectal Cancer With ALK Mutation.

Summary: This clinical trial aims to evaluate the efficacy, safety of ALK inhibitor in Metastatic Colorectal Cancer Patients with ALK mutation.


Eligibility: Inclusion Criteria:
  Patients should be histologically diagnosed with metastatic colorectal cancer or postoperative recurrence; Patients with ALK mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;
  Exclusion Criteria:
  Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Safety Observation on hESC Derived MSC Like Cell for the Meniscus Injury

Summary: human embryonic stem cell derived mesenchymal stem cells like cell for the meniscus injury, and observe the safety of the cells for meniscus injury

Detailed description: Three different dosage of human embryonic stem cell derived mesenchymal stem cells like for meniscus injury patients, and observe the safety of the cells for meniscus injury.

Eligibility: Inclusion Criteria:
  -  Grade Ⅰ-Ⅱ meniscus injury of knee joint
  -  The patients who still have the pain of knee joint and/or limitation of the function after accepted 3 months of nonoperative treatment
  Exclusion Criteria:
  -  Recent history of lower limb fractures or intra-articular drug injection
  -  The patients who have meniscus injury of knee joint need the surgical repair
  -  The patients who have the severe coagulation disorders, cardiopulmonary failure and so on
  -  The women who are pregnant or nursing
  -  There are electronic implants such as pacemakers in the body
  -  The patients who are infected the HIV, the virus of hepatitis or syphilis
  -  The patients who are alcoholism or drug user
  -  The patients who have vestibular and balance disorders
  -  The patients with severe cognitive impairment who cannot follow instructions to complete the treatment
  -  The patients who don't sign the informed consent
  -  The patients who have tumor
  -  Immunodeficiency patients
  -  The patients who have congenital or acquired knee malformation
  -  Patients or researchers who are participating in other clinical trials believe that other reasons are not appropriate for clinical trials

Relevance to patient case: not relevant
Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: Early Assessment of Response to Treatment of Metastatic LUng Tumors Based on CIrculating Tumor DNA

Summary: In patients with locally advanced or metastatic tumors, first-line therapeutic management is based on the use of targeted therapies (EGFR, BRAF ALK and ROS1 inhibitors), immunotherapies (anti-PD1/ anti-PDL1-antibodies or chemotherapy.
  Despite patient selection based on histo-pathological and molecular criteria, not all patients respond to treatment. There are currently no markers to definitively guarantee a patient's response.
  An alternative is to identify early patient response to treatment. The investigator hypothesize that change in circulating tumor DNA concentration (ctDNA) allow to early identify patients' therapeutic response (and non-response) of patients, regardless of the type of treatment used in the first line setting.

Detailed description: The primary objective is to determine whether early evolution (between baseline and week 3) of circulating tumor DNA concentration predicts the radiological response to first-line treatment of advanced or metastatic NSCLC patients, regardless of treatment

Eligibility: Inclusion Criteria:
  -  Metastatic or locally advanced non-small cell lung cancer (stage III or IV)
  -  At least one measurable target according to RECIST criteria
  -  Identification of at least one molecular alteration in the tissue sample analyzed in the framework of patient management
  -  Performance Status 0 to 2
  -  Affiliated to a social security system
  -  Patient who can be followed under the protocol
  -  Patient agreed to participate in the study and gave his/her express consent
  Exclusion Criteria:
  -  Minor Small cell or mixed bronchial cancer
  -  Patient operated
  -  Radiotherapy (except radiotherapy for antalgic purposes) during the last 7 days
  -  Patient who has already started a first line of treatment
  -  Patient already included in an interventional research protocol that may have an impact on the results of the ELUCID study
  -  History of cancer (with the exception of non-melanoma skin, cervical cancer in situ, adequately treated) with no sign of illness during the last 5 years and which, does not present a substantial risk of recurrence.
  -  Major under guardianship, curators or deprived of liberty
  -  Pregnant or lactating woman, or of childbearing age without effective contraception
  -  Not affiliated to a social security system
  -  Inability to understand the protocol and / or to give express consent

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

Summary: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).
  SECONDARY OBJECTIVES:
  I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.
  II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.
  Arm I:Patients receive no further therapy.
  Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
  Patients are followed every 4 months for 2 years and then every 6 months thereafter.

Eligibility: Inclusion Criteria:
  -  Histologically documented non-small cell carcinoma
  -  Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
  -  Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
  -  Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
  -  No prior chemotherapy or radiation for non-small cell lung cancer
  -  Performance status of 0 or 1
  -  Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
  -  Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
  -  Granulocytes >= 1,800/ul
  -  Platelets >= 100,000/ul
  -  Bilirubin < 1.5 mg/dl
  -  SGOT (AST) < 2.0 x ULN

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia

Summary: RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body build an effective immune response to kill cancer cells.
  PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia.
  -  Determine the toxicity of this vaccine in these patients.
  Secondary
  -  Determine whether cellular immunity can be induced by this vaccine in these patients.
  OUTLINE: This is a dose-escalation study.
  At the time of diagnosis, patients undergo tumor cell harvest. Patients also undergo bone marrow aspiration to collect mononuclear cells to obtain dendritic cells (DC). If insufficient DCs are obtained, patients undergo leukapheresis to obtain a sufficient number of peripheral blood mononuclear cells (PBMC). The PBMC are treated in the laboratory with sargramostim (GM-CSF) and interleukin-4 for 5-7 days to produce DC. Leukemic blasts are fused to DC to generate the dendritic/leukemic fusion cell vaccine.
  Patients then undergo standard induction chemotherapy to obtain a remission, followed by standard consolidation chemotherapy.
  After completing consolidation chemotherapy, patients receive autologous dendritic and leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity.
  Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion cell vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.
  Patients are followed every 3 months for 5 years.
  PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy
  -  Newly diagnosed
  -  Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood
  -  No clinical evidence of CNS leukemia
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Not specified
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Not specified
  Other
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  -  HIV negative
  -  No clinically significant autoimmune disease
  -  No other active malignancy except nonmelanoma skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 3 months since prior immunotherapy
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Summary: Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

Detailed description: We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Eligibility: Inclusion Criteria:
  -  Pathologically / cytologically proven ADC-P
  -  Non-resectable disease
  -  3-month expected survival
  -  No prior radiotherapy or chemotherapy
  -  Age >= 18 years old
  -  Performance status < 4 (WHO)
  -  Adequate blood biological parameters
  Exclusion Criteria:
  -  Abnormal initial fibroscopy

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Genetic Epidemiological Study of Lung Cancer in Taiwan and Clinical Applications

Summary: Lung adenocarcinoma in Chinese females is hypothesized to be determined by both genetic and environmental factors. In this grant proposal, we propose to map the loci of susceptibility genes of female lung adenocarcinoma based on multiplex families recruited in Taiwan. We focus on a unique pathological type of a unique population in order to reduce heterogeneity of the genetic background. Compared with western women, female Chinese population has a high prevalence of lung adenocarcinoma. Our reasoning is that if we focus on a specific sub-type, which has a familial basis, we will increase the probability of identifying genes associated with female lung adenocarcinoma. The primary goal of this study is to identify the genetic and environmental determinants of female lung adenocarcinoma, and study the relationship between gene polymorphisms and clinical manifestation profiling of lung cancer.

Detailed description: This research proposal intends to integrate epidemiologists, biostatisticians, clinicians, molecular biologists/geneticists to identify susceptible genes for lung cancer, especially for female lung adenocarcinoma, and to study the relationship between gene polymorphisms and clinical outcomes of lung cancer patients. Our objective is to find gene markers for developing useful screening tools for the high risk group in order to prevent or early detect lung cancer, especially female lung adenocarcinoma.
  The specific aims of this subproject include:
  1. Establish and maintain the research network that will recruit and follow up the subjects and families for the GEFLAC study; keeping control of the progress of the study.
  2. Coordinate all the subprojects such as integrating genotyping data with clinical data and environment data.
  3. Continue to employ the candidate gene approach to examine the contribution of specific genes to the lung cancer.
  4. Generate genotyping data for candidate genes in the exploring stage and prioritize SNPs of candidate genes for large scale studies.
  5. Identify susceptible genes/candidate genes to develop multiplex PCR for screening.

Eligibility: Inclusion Criteria:
  -  lung adenocarcinoma
  Exclusion Criteria:
  -

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Positron Emission Tomography Scan and CT Scan in Planning Radiation Therapy for Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Imaging procedures, such as positron emission tomography (PET) scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.
  PURPOSE: This clinical trial is studying how well a combined PET scan and CT scan works compared to a CT scan alone in planning radiation therapy for patients with stage II or stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the impact of positron emission tomography (PET)/CT fusion scan and CT scan alone, by comparing gross tumor volume (GTV) contours and three-dimensional conformal radiotherapy treatment plans using 2 separate data sets (PET/CT fusion scan and CT scan only), in patients with stage II or III non-small cell lung cancer who are planning to undergo radiotherapy.
  -  Determine the impact of PET on GTV (cm^3), number of involved nodes, location of involved nodes, and dosimetric measures of normal tissue toxicity (mean lung dose, V20, and mean esophageal dose).
  Secondary
  -  Determine the rate of elective nodal failures (nodal failures in regions that are not intentionally irradiated to definitive doses [i.e., ipsilateral hilum, mediastinum, or ipsilateral supraclavicular fossa]).
  OUTLINE: This is a multicenter study. Patients are stratified according to neoadjuvant chemotherapy (yes vs no).
  Patients undergo a combined positron emission tomography (PET)/CT scan. Patients also undergo a CT scan alone. A single three-dimensional conformal radiotherapy (3DCRT) plan is generated from the combined PET/CT scan results. A single 3DCRT plan using the planning target volume is derived from the CT scan only.
  Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
  PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  -  Stage IIA/IIB or stage IIIA/IIIB disease
  -  Planning to undergo radiotherapy
  -  Local or regional nodal recurrence after surgery allowed
  -  No malignant pleural effusion
  PATIENT CHARACTERISTICS:
  -  Zubrod performance status 0-2
  -  Negative pregnancy test
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  Concurrent neoadjuvant and/or concurrent chemotherapy allowed
  -  No concurrent intensity-modulated radiotherapy

Relevance to patient case: not relevant
Patient case: 72-year-old male with lung adenocarcinoma; genetic feature: EZR-ROS1 fusion

Clinical trial: Study of BMS-275183 in Patients With Pretreated Locally Advanced or Metastatic NSCLC (Non Small Cell Lung Cancer)

Summary: BMS-275183 given orally twice weekly to patients pretreated for locally advanced or metastatic NSCLC will show anti-tumor activity in any of the 3 separate cohorts of the patients enrolled:
  -  Cohort I: Patients previously treated with one taxane containing regimen.
  -  Cohort II: Patients previously treated with a platinum based but non-taxane containing regimen.
  -  Cohort III: Patients previously treated with both a chemotherapy regimen and one EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor) compound.
  Patients in cohorts I and II should have not been treated with a prior EGFR-TKI compound. Prior treatment with a VEGFR (vascular endothelial growth factor receptor) inhibitor compound is allowed for all the patients provided that the VEGFR inhibitor is not also an EGFR inhibitor.


Eligibility: Inclusion Criteria:
  -  Men and women, age >= 18 years
  -  Subjects with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen.
  Exclusion Criteria:
  -  Concomitant medication with a cytochrome P450 (CYP) 3A4 inhibitor or inducer

Relevance to patient case: not relevant