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

Clinical trial: Comparison of qPCR to IHC and FISH for Detection of ALK Fusion Mutations in FFPE Tissue From NSCLC Patients

Summary: The anaplastic lymphoma kinase gene(ALK) is mutated approximately 5% of non-small cell lung cancers. Testing for this gene is important because there are drugs known as ALK inhibitors that have been shown to significantly delay the progression of ALK-mutated lung cancers. There are a number of ways to test for the presence of the ALK gene in lung cancer biopsy tissue. One method involves making slides and staining them to detect the ALK protein. This is called immunohistochemistry. Another method called fluorescence in situ hybridization(FISH)is used to detect rearrangements of the ALK gene associated with lung cancer. Although both these tests are widely used to test for ALK gene abnormalities, the techniques may not always find the ALK gene mutation because they are not sensitive enough or not enough cancer cells are present in the lung biopsy.
  This study is being performed to determine if a technique called quantitation polymerase chain reaction (qPCR) is as accurate or better at finding the ALK gene mutation in lung cancer biopsy tissue.


Eligibility: Inclusion Criteria:
  -  You have a confirmed diagnosis of non-squamous, non-endocrine non-small cell lung cancer.
  -  Your cancer biopsy has sufficient cancer cells to be tested for the (Epidermal Growth Factor Receptor (EGFR) mutation, the ALK fusion gene abnormality and the research ALK testing.
  -  Your lung cancer biopsy is determined not to have a mutation in the EGFR gene.
  -  You are 19 years old or older.
  -  You fully understand the study and give informed consent to participate as demonstrated by signing the consent.

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

Clinical trial: SAIF: Sacroiliac Fusion Study

Summary: The purpose of the SAIF study is to evaluate the SImmetry Sacroiliac Joint Fusion System for fusion and pain reduction of the SI joint.

Detailed description: This is a prospective, non-randomized, single center study to collect data on fusion and pain reduction following implantation of the SImmetry device. Up to 15 total subjects will be implanted and followed for 24 months. Data will be collected pre-operatively, at implant, discharge, and at specified follow-up time points (6 weeks, 3 months, 6 months, 12 months, 24 months.)

Eligibility: Inclusion Criteria:
  -  Subjects must be indicated for the SImmetry device according to the approved SImmetry labeling
  -  Subject has three (3) positive (experiences pain) Provocative Tests for SIJ pain; for example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's
  -  Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6 months prior to surgery; for example, use of medications, braces, SI belts, orthotics, physical therapy or manual manipulation
  -  The subject has one (1) positive diagnostic SIJ injection, resulting in a ≥50% decrease in pain from the anesthetic portion of the injection
  -  The subject has VAS back pain score of ≥ 60 mm
  -  The subject has an ODI ≥ 40%
  -  The subject is at least 18 years of age and skeletally mature
  -  The subject agrees and is able to comply with study requirements
  Exclusion Criteria:
  -  Subjects contraindicated per the cleared labeling will be excluded from participation in the study
  -  The subject has pelvic soft tissue or bony tumors
  -  The subject has had any trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit
  -  The subject has a history of a central nervous system (CNS) disorder(s)
  -  The subject is pregnant or is planning on becoming pregnant in the next two years
  -  The subject has chemical dependency problems as evidenced by a history of drug abuse which is documented in their past medical history or is elicited from an interview
  -  The subject has a history of significant emotional or psychosocial disturbance (anxiety attacks, obsessive/compulsive disorders, depression or schizophrenia) as documented in their past medical history or elicited by an interview

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

Clinical trial: A Study Of PF-06647263 In Patients With Advanced Solid Tumors

Summary: To assess the safety and tolerability at increasing dose levels of PF-06647263 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Detailed description: The clinical study will include 2 parts. Part 1 will estimate the MTD in dose escalation cohorts in patients with advanced solid tumors for whom no standard therapy is available in order to establish the RP2D. Part 2 will include patients with previously treated metastatic triple negative breast cancer (TNBC).

Eligibility: Inclusion Criteria:
  -  Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
  -  Performance Status of 0 or 1
  -  Adequate bone marrow, kidney, and liver function
  -  Part 2 includes advanced triple negative breast cancer patients.
  Exclusion Criteria:
  -  Brain metastases requiring steroids
  -  Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start
  -  Active and clinically significant bacterial, fungal or viral infection

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

Clinical trial: A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Summary: A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

Detailed description: This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

Eligibility: Inclusion Criteria:
  -  Aged at least 18 years.
  -  Documented evidence of NSCLC (stage IIIB/IV disease)
  -  Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
  -  World Health Organisation (WHO) Performance Status of 0 or 1
  -  Estimated life expectancy of more than 12 weeks
  -  Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))
  Exclusion Criteria:
  -  Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  -  Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
  -  Active or prior autoimmune disease or history of immunodeficiency
  -  Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  -  Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
  -  Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
  -  Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
  -  Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

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

Clinical trial: Study of Oral RXDX-101 in Adult Patients With Locally Advanced or Metastatic Cancer Targeting NTRK1, NTRK2, NTRK3, ROS1, or ALK Molecular Alterations.

Summary: Entrectinib (RXDX-101) is an orally available inhibitor of the tyrosine kinases TrkA (coded by the gene NTRK1), TrkB (coded by the gene NTRK2), TrkC (coded by the gene NTRK3), ROS1 (coded by the gene ROS1), and ALK (coded by the gene ALK). Molecular alterations to one or more of these targets are present in several different tumor types, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), prostate cancer, papillary thyroid cancer, pancreatic cancer, and neuroblastoma. Patients with locally advanced or metastatic cancer with a detectable molecular alteration in targets of interest may be eligible for enrollment.
  Phase 1 will assess safety and tolerability of entrectinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and efficacy will be assessed in the dose expansion portion of the study.


Eligibility: Key Inclusion Criteria:
  -  Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a NTRK1, NTRK2, NTRK3, ROS1, or ALK molecular alteration.
  -  Measurable disease according to RECIST version 1.1.
  -  Prior cancer therapy is allowed, including crizotinib, ceritinib, and investigational drugs.
  -  Prior radiotherapy is allowed
  -  Patients with controlled asymptomatic central nervous system involvement are allowed.
  -  Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
  -  Adult patients age 18 years or older.
  -  Life expectancy of at least 3 months.
  Key Exclusion Criteria:
  -  Current participation in another therapeutic clinical trial.
  -  Prior treatment with entrectinib.
  -  History of prolonged QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds).
  -  History of additional risk factors for torsade de pointes (e.g., family history of long QT syndrome).
  -  Known active infections (bacterial, fungal, viral including HIV positivity).
  -  Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
  -  Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis.
  -  Peripheral neuropathy ≥ Grade 2.

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

Clinical trial: A Study to Test the Safety of the Investigational Drug Larotrectinib in Adults That May Treat Cancer

Summary: This research study is done to test the safety of the drug larotrectinib in adult cancer patients. The drug may be used to treat cancer with a change in a particular gene (NTRK1, NTRK2 or NTRK3), because it blocks the action of these genes in cancer cells. The study also investigates how the drug is absorbed and processed in the human body. This is the first study to test larotrectinib in humans with cancer, for whom no other effective therapy exists.

Detailed description: The trial will be conducted in 2 parts: an initial dose escalation phase of larotrectinib in subjects with advanced solid tumors will be followed by an expansion phase in subjects with solid tumors having a NTRK fusion.
  The objectives of the study are to determine the safety, pharmacokinetic profile, recommended dose and efficacy of orally administered larotrectinib in patients with NTRK fusions.

Eligibility: Inclusion Criteria:
  -  Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists.
  -  Proof of a malignancy harboring a NTRK fusion
  -  Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 and a life expectancy of at least 3 months
  -  Adequate hematologic, hepatic, and renal function
  Exclusion Criteria:
  -  Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible
  -  Clinically significant active cardiovascular disease or history of myocardial infarction
  -  Active uncontrolled systemic bacterial, viral, or fungal infection
  -  Current treatment with a strong CYP3A4 inhibitor or inducer
  -  Pregnancy or lactation

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

Clinical trial: Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)

Summary: The purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study.

Detailed description: Study was terminated due to low enrollment.

Eligibility: Inclusion Criteria:
  -  Patient had a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and was in need of treatment because of radiologic progression or relapse.
  -  Patient must have been pre-identified as having a tumor with an ALK or ROS1 positive mutation, translocation, rearrangement or amplification. The qualifying alteration must have been assessed and reported by a CLIA-certified laboratory. ALK positivity as assessed by IHC or FISH were allowed.
  -  Patient must have received at least one prior treatment for recurrent, metastatic and/or locally advanced disease and for whom no standard therapy options were anticipated to result in a durable remission.
  -  Patient had progressive and measurable disease as per RECIST 1.1 or other appropriate hematological guidelines.
  -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  Exclusion Criteria:
  -  Patient had received prior treatment with ceritinib.
  -  Patients with symptomatic CNS metastases who were neurologically unstable or required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms.
  -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, monoclonal antibodies or mitomycin-C) prior to starting study drug.

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

Clinical trial: Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

Summary: This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
  NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.
  Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.
  The study will enable real-life Heath Economics and Outcome Research (HEOR).
  Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.


Eligibility: Inclusion Criteria:
  -  Patients with histologically confirmed locally advanced or metastatic NSCLC
  -  Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
  -  Planned first or second-line treatment with crizotinib
  -  Signed and dated IRB-approved informed consent document
  -  Ability to read and understand English or French
  -  18 years of age or older

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

Clinical trial: A Study of DCC-2701 in Participants With Advanced Solid Tumors

Summary: The main purpose of this study is to investigate the safety of the investigational drug DCC-2701 and whether it will work to help people who have advanced solid tumors or cancer that has spread to other parts of the body.

Detailed description: This is a first-in-human study of DCC-2701. The primary purpose of this study is to determine what dose of DCC-2701, can be given safely to patients with advanced solid tumors.
  The study will have two phases. The first phase will assess escalating doses of DCC-2701 in order to determine the maximally tolerated dose (MTD) and the optimal dosing regimen (ODR) of DCC-2701. Once the MTD and ODR is established, a dose expansion phase will further evaluate the safety of DCC-2701, as well as the activity of DCC-2701 in select solid tumor types.

Eligibility: Inclusion Criteria:
  -  Advanced or metastatic solid tumor that has progressed or was not responsive to standard therapy
  -  The cancer has no proven effective therapy
  -  The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
  -  Able to swallow tablets
  Exclusion Criteria:
  -  Have active central nervous system (CNS) metastasis
  -  Have an active infection of any kind (fungal, viral, or bacterial)
  -  Are pregnant or breastfeeding

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

Clinical trial: A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery

Summary: The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.

Detailed description: This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.

Eligibility: Inclusion Criteria:
  -  20-70 years old, male or female;
  -  Subject being diagnosed as having disc degeneration disease, spondylolisthesis, spinal fracture, deformity(degenerative deformity), spinal stenosis, or spinal tumor, has been treated with conservative treatment without relief or getting worse, who is suitable for surgery according to clinic practice.
  -  Subject is a suitable candidate for implanting investigational products described in study protocols according to investigator's assessment;
  -  Patient, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and willing to be available for each required study procedure over the study duration.
  -  Subject has been given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to study Sponsor.
  Exclusion Criteria:
  -  Patient has a local or systemic infection.
  -  Patient has had one or more previous non-fusion spinal surgery at the involved level(s).
  -  Patient without spinal deformity and requires fusion at 3 or more levels.
  -  Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
  -  Has presence of active malignancy
  -  Has a medical condition with less than 1 year of life expectancy.
  -  Pregnancy or women in lactation period.
  -  Is grossly obese, i.e. Body Mass Index≥40.
  -  Has a diagnosis, which requires postoperative medication or treatment that interferes with fusion, such as steroids, chemotherapy, radiotherapy, growth factor (for more than 3 months), Nonsteroidal Antiinflammatory Drugs(for more than 3 months), and etc.
  -  Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. uncontrolled Diabetes with medication, renal osteodystrophy, or osteogenesis imperfect)
  -  Alcoholic (taking more than 40g/day, equals to 100ml 50°Chinese liquor), smoking more than 40 cigarettes/day, or Drug abuser;
  -  Is currently participating in another investigational drug or device study.

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

Clinical trial: Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations

Summary: The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions.
  The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.


Eligibility: Inclusion Criteria:
  -  Male or female aged ≥ 18 years
  -  Histological or cytological confirmed metastatic colorectal cancer
  -  Written documentation of KRAS wild-type status and BRAFV600-mutation with RNF43 mutation and/or RSPO fusion
  -  Progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens
  -  Availability of a representative tumor specimen (primary or metastatic, archival or newly obtained)
  -  Measurable disease as per RECIST v1.1
  -  Eastern cooperative oncology group (ECOG) performance status ≤ 2
  Exclusion Criteria:
  -  Phase II only: Prior treatment with RAF inhibitors, Wnt pathway inhibitors, cetuximab, panitumumab, and/or other EGFR inhibitors
  -  Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll
  -  Current treatment with medications or consuming foods that are strong inhibitors or inducers of CYP3A4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment.
  -  Symptomatic or untreated leptomeningeal disease
  -  Acute or chronic pancreatitis
  -  Clinically significant cardiac disease
  -  Patients with any of the following laboratory values at Screening/baseline
  -  Absolute neutrophil count (ANC) <1,500/mm3
  -  Platelets < 100,000/mm3
  -  Hemoglobin < 9.0 g/dL
  -  Serum creatinine >1.5 x ULN or calculated or directly measured CrCl < 50% lower limit of normal
  -  Serum total bilirubin >1.5 x ULN
  -  AST/SGOT and/or ALT/SGPT > 2.5 x ULN, (> 5 x ULN if liver metastases present)
  -  Patients with impaired hepatic function as defined by Childs-Pugh class B or C
  -  Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral WNT974/LGX818
  Other protocol-defined inclusion/exclusion criteria may apply

Relevance to patient case: not relevant