araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Summary: The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.
  Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.


Eligibility: Inclusion Criteria:
  -  Histologically proven urothelial bladder cancer
  -  Intermediate risk NMIBC
  -  ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
  -  Imaging study excluding upper urinary tract TCC
  Exclusion Criteria:
  -  Pregnant and lactating women;
  -  Advanced co-existing medical or psychiatric disorders;
  -  Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
  -  History of allergy to sulfonamide drugs;
  -  Concomitant investigational medications.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Summary: Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

Detailed description: Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.
  After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Eligibility: Inclusion Criteria:
  1. Have suspected or known invasive (≥T1) bladder cancer
  2. Be able to give informed consent
  3. Be age 18 or older
  4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
  Exclusion Criteria:
  1. Have non-invasive (<T1) bladder cancer
  2. Unable to give informed consent
  3. < 18 or older
  4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)

Summary: To evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY1187982 in subjects with advanced solid tumors known to express fibroblast growth factor receptor 2 (FGFR2)


Eligibility: Inclusion Criteria:
  -  All subjects must be >/= 18 years at the first screening examination / visit
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  -  Subjects with advanced, histologically or cytologically confirmed solid tumors described to express fibroblast growth factor receptor 2 (FGFR2) that are refractory to any standard therapy
  -  For maximum tolerated dose (MTD) Dose Expansion: Subjects with advanced, histologically or cytologically confirmed triple-negative breast cancer who had undergone within 4 lines of systemic anti-cancer treatment and not eligible for standard therapy anymore.
  -  Subjects need to have evaluable disease (measurable or not measurable).
  -  Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
  Exclusion Criteria:
  -  History of allergic reactions to monoclonal antibody therapy (or excipients in the formulation)
  -  Anti-cancer chemotherapy, experimental cancer therapy including clinical trial, or cancer immunotherapy within 4 weeks prior to the first dose of the investigational drug.
  -  Toxic effects of previous anti-cancer chemotherapy, experimental cancer therapy, or cancer immunotherapy have not normalized.
  -  History of symptomatic metastatic brain or meningeal tumors unless the subject is longer than 3 months from the end of definitive therapy before the first dose of the investigational drug and has clinically or radiologically no evidence of tumor growth.
  -  History of clinically significant cardiac disease
  -  Congenital coagulation abnormalities
  -  Subjects who are pregnant or are breast-feeding

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

Summary: This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.
  This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.
  To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.


Eligibility: Inclusion Criteria:
  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values
  -  Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
  -  bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
  -  creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.
  Exclusion Criteria:
  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. Any previous treatment with Pazopanib.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: CIK in Treating Patients With Bladder Cancer

Summary: Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder Cancer.

Detailed description: About 1500 patients with staging I-III of Bladder Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility: Inclusion Criteria:
  -  Patients histologically confirmed carcinoma in of the bladder with urinary cytology;
  -  Patients with staging I-III of Bladder Cancer;
  -  Patients who had completed chemotherapy;
  -  Patients who have a life expectancy of at least 12 weeks;
  -  Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
  -  The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L);
  -  The ECG results were normal, and the liver and kidney were functional.
  Exclusion Criteria:
  -  Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk;
  -  Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization;
  -  Patients who had prior or concurrent upper urinary tract tumors;
  -  Patients who had distant metastases by imaging studies;
  -  Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
  -  Patients who were lactating;
  -  ECOG perform status ≥ 2;
  -  Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
  -  Patients who are pregnant or nursing;
  -  Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
  -  Patients with disease that would preclude general anesthesia;
  -  Patients with active intractable or uncontrollable infection.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Characterization of Anti-FGFR3 Antibodies

Summary: Sensory neuronopathies affect sensory neuron in the posterior spinal ganglion. They are responsible for pain, balance disorder (ataxia) and the use of hands. They depend on multiple etiologies. In a retrospective study, the investigators showed that the anti-FGFR3 antibody is a diagnostic marker of a subset of sensory neuronopathies. The investigators believe that other antibodies can be discovered in patients who remain seronegative changing.
  However, the study is retrospective and only a small number of patients could be identified. Several points therefore need to be clarified or confirmed in a second prospective study.

Detailed description: In and out patients evaluated for a sensory neuropathy meeting the inclusion and non-inclusion criteria will be proposed to enter the study
  At inclusion the SSN diagnostic score is calculated and a blood sample is tested for anti-FGFR3 antibody.
  Follow up: Patients positive for anti-FGFR3 antibodies will be followed and evaluated clinically and electrophysiologically at 1, 6 and 12 months. A blood sample is taken at 6 and 12 months.
  A subgroup of patients negative for anti-FGFR3 antibodies will be randomly selected for evaluation at 1, 6 and 12 months.

Eligibility: Inclusion Criteria:
  -  A :Patients Male or female patient aged 18 years or more
  Patients with a clinically pure sensory peripheral neuropathy including :
  -  idiopathic or dysimmune sensory neuronopathies
  -  idiopathic or dysimmune distal axonal sensory neuropathy
  -  sensory chronic inflammatory demyelinating polyradiculoneuropathy
  -  idiopathic or dysimmune small fiber neuropathies
  -  idiopathic or dysimmune trigeminal nerve neuropathy
  -  positive to antibodies anti-FGFR3
  B :Controls Male or female patient aged 18 years or more
  Patients with a clinically pure sensory peripheral neuropathy including :
  -  idiopathic or dysimmune sensory neuronopathies
  -  idiopathic or dysimmune distal axonal sensory neuropathy
  -  sensory chronic inflammatory demyelinating polyradiculoneuropathy
  -  idiopathic or dysimmune small fiber neuropathies
  -  idiopathic or dysimmune trigeminal nerve neuropathy
  -  negative to antibodies anti-FGFR3
  Exclusion Criteria:
  -  -Motor or sensory-motor neuropathies
  -  Genetic, toxic, paraneoplasic neuropathies
  -  Diabetic Neuropathy.
  -  Neuropathy with Anti-MAG or anti-ganglioside IgM.
  -  Pregnant or breastfeeding woman

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

Summary: This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.


Eligibility: Inclusion Criteria:
  -Patients treated with BOTOX® for Overactive Bladder.
  Exclusion Criteria:
  -  Received botulinum toxin formulations other than BOTOX® in the bladder.
  -  Had symptoms of OAB associated with a neurological condition.
  -  Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: A Study of Ibandronate (Bondronat) in Participants With Malignant Bone Disease

Summary: This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 individuals.


Eligibility: Inclusion Criteria:
  -  Adults at least 18 years of age
  -  Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
  -  Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
  -  Radiologically confirmed bone disease disease
  Exclusion Criteria:
  -  Previous treatment with ibandronate (Bondronat) within previous 2 months
  -  Severely impaired renal function
  -  Known brain metastases

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

Summary: Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.


Eligibility: Inclusion Criteria:
  -  Age: 18 to 85 years old
  -  Suspected BC based on cystoscopical evaluation.
  -  Mental status: Patients must be able to understand the meaning of the study
  -  Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
  Exclusion Criteria:
  -  History of serious cardiovascular, liver or kidney disease
  -  Uncontrolled serious infection
  -  Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  -  Patient refusing radical cystectomy or chemotherapy or BCG
  -  Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Quality of Life After Bladder-Preservation Chemotherapy and Radiation Therapy in Patients With Muscle-Invasive Bladder Cancer

Summary: This research trial studies quality of life after bladder-preservation chemotherapy and radiation therapy (chemo-radiotherapy) in patients with bladder cancer that has spread into or through the muscle layer of the bladder (muscle-invasive bladder cancer). Bladder-preservation chemo-radiotherapy is a standard treatment for patients with muscle-invasive bladder cancer, however, chemo-radiotherapy may cause urinary tract, bowel, and sexual late side effects that negatively affect patients' quality of life. Studying quality-of-life in patients with muscle-invasive bladder cancer after chemo-radiotherapy may help identify the long-term side effects of treatment and may help plan the best treatment in the future and improve patients' quality of life.

Detailed description: PRIMARY OBJECTIVES:
  I. To study health-related quality of life (HRQoL, or QOL) for patients undergoing protocol-based bladder-preservation chemo-radiation.
  OUTLINE:
  Patients complete the European Organization for Research and Treatment for Cancer (EORTC) QLQ-Bladder Cancer Muscle Invasive (BLM-C30) at baseline, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of chemo-radiotherapy.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed muscle-invasive urothelial cancer (no histology will be excluded)
  -  No pelvic nodal metastases or distant metastases (based on computed tomography [CT], positron emission tomography [PET] or magnetic resonance imaging [MRI])
  -  Karnofsky performance status (KPS) >= 70
  -  Ability to understand, and willingness to sign, the written informed consent
  -  Patient will have either opted for bladder-sparing treatment as compared to radical cystectomy, or deemed medically inoperable
  -  Following the recent recommendations from the International Consultation on Urological Diseases-European Association of Urology International Consultation on Bladder Cancer, eligible patients will be those with no hydronephrosis, no extensive carcinoma in situ (CIS), and no tumor invasion into the stroma of the prostate
  Exclusion Criteria:
  -  Patients with any evidence of distant metastases
  -  Prior pelvic radiotherapy
  -  History of Crohn's disease or ulcerative colitis
  -  Unable to receive chemotherapy
  -  Histologies other than urothelial (eg. squamous cell carcinoma, adenocarcinoma, small cell)

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  FGFR2 amplification ,Refractory solid tumor and/or specific sensitivity to by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, pazopanibPlatelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with pazopanib

Relevance to patient case: not relevant
Patient case: 64-year-old male with bladder cancer; genetic feature: FGFR3 (S249C)

Clinical trial: Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors

Summary: This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  To investigate the efficacy and safety of Sunitinib in patient with Refractory solid tumor.


Eligibility: Inclusion Criteria:
  -  Provision of fully informed consent prior to study specific procedures.
  -  Patients must be >= 19 years of age
  -  RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
  -  ECOG Performance status0-2
  -  Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
  -  Adequate Organ Function Laboratory values
  -  Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT <= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) Creatinine<= 1.5 X UNL
  -  Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
  -  Adequate heart function
  Exclusion Criteria:
  -  Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
  -  Has known active central nervous system(CNS) metastases
  -  Has an active infection requiring systemic therapy
  -  Pregnancy or breast feeding
  -  Patients with cardiac problem
  -  Any previous treatment with sunitinib

Relevance to patient case: not relevant