araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma

Summary: This is a study to determine the safety and effectiveness of high-dose radiation therapy (RT) with concurrent temozolomide in patients with newly diagnosed glioblastoma.


Eligibility: Inclusion Criteria:
  -  Newly diagnosed histologically-confirmed supratentorial World Health Organization (WHO) grade IV gliomas including glioblastoma multiforme and gliosarcoma
  -  Age 18 or older
  -  Karnofsky performance status (a measure to quantify general well being and activities of daily life; scale ranges from 0 to 100 where 100 is perfect health) of greater than or equal to 70
  -  Life expectancy of at least 12 weeks
  -  Adequate bone marrow reserve (hemoglobin greater than or equal to 10, absolute neutrophil count greater than or equal to 1500, platelets greater than or equal to 100,000); acceptable liver function (total bilirubin less than or equal to 2.0 mg/dl, ALT (Alanine Aminotransferase)/AST (Aspartate Aminotransferase) less than or equal to 5 times the normal range); acceptable renal function (serum creatinine less than or equal to 2.0 mg/dl). Eligibility level for hemoglobin may be reached by transfusion.
  -  Maximal contiguous volume of tumor based on high b-value diffusion MRI < 1/3 volume of brain
  -  Patients must be registered within 6 weeks of most recent resection.
  -  Patients must have signed a study-specific informed consent.
  Exclusion Criteria:
  -  Recurrent glioma, or tumor involving the brainstem or cerebellum. Prior low-grade glioma without prior RT, now with malignant progression are eligible.
  -  Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment is not permitted. Prior chemotherapy for a different cancer is allowable, except for Temozolomide or Bevacizumab.
  -  Evidence of cerebrospinal fluid dissemination (positive cerebrospinal fluid cytology for malignancy or MRI findings consistent with CSF dissemination)
  -  Evidence of severe concurrent disease requiring treatment
  -  Prior invasive malignancy (except non-melanoma skin cancer) unless disease-free for a minimum of 3 years (for example, carcinoma in situ of breast, oral cavity or cervix are all permissible)
  -  Patients unable to undergo Magnetic Resonance Imaging exams (MRI) (i.e. patients with non-compatible devices such as cardiac pacemakers, other implanted electronic devices, metallic prostheses, or ferromagnetic prostheses (e.g. pins in artificial joints and surgical pins/clips) or unable to receive gadolinium for MRI, as per the standard UM Department of Radiology MRI screening criteria)
  -  Patients treated with previous cranial or head/neck radiotherapy leading to radiation field overlap
  -  Females of child-bearing potential must have a negative pregnancy test within 14 days prior to registration. Patients with reproductive potential must agree to use an effective contraceptive method during treatment.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)

Summary: The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized cellular vaccines including autologous tumor cells, antigen pulsed DCs and allogeneic peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.

Detailed description: This is an open label, single-arm, single-institution, Phase I/II study designed to investigate the safety and efficacy of personalized cellular vaccines for patients with recurrent glioblastoma (GBM). Recurrent GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. The tumor cells will be irradiated and used as vaccines. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs or allogeneic PBMCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive a total of twelve vaccines consisting of autologous tumor cells, DCs or PBMCs. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the efficacy of the vaccines using iRANO criteria, progression-free survival and overall survival. In addition, the antitumor specific T cell responses will be measured.

Eligibility: Inclusion Criteria:
  -  Recurrent glioblastoma grade IV
  -  Patients at the age of 18-65.
  -  Patients undergo tumor resection.
  -  Patients with Karnofsky scores > or =70
  -  Patients with normal range of hematologic and metabolic test results.
  -  Patients must have no corticosteroids treatment at least one week before vaccination.
  -  Patients capable of understanding the study and signed informed consent.
  Exclusion Criteria:
  -  Breast feeding females.
  -  Pregnant women.
  -  Infectious diseases HIV, HBV, HCV
  -  Documented immunodeficiency
  -  Documented autoimmune disease
  -  Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
  -  Patient inability to participate as determined by PI discretion.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Emotions Analysis in Patients With Chronic Phase of Stroke Basal Ganglia

Summary: Compare the emotional experience of patients with focal lesions of the basal ganglia by ischemic or hemorrhagic damage and healthy participants. These anomalies will be highlighted by neuropsychological and electrophysiological assessments.


Eligibility: Inclusion Criteria:
  -  For cases :
  -  right-handed patient
  -  ischemic or hemorrhagic stroke older than 3 months with single lesion preferably less than 20 mm in diameter affecting the basal ganglia and sparing cortex
  -  Rankin score estimated prior stroke must be equal to 0 and after stroke <3 (at inclusion).
  -  For participants control : right-handed patient
  Exclusion Criteria:
  -  For cases : severe aphasia - Prosopagnosia apperceptive - cerebral neurological pathology associated history, especially dementia - History of depression and psychiatric disorders treated - another stroke vascular territory than that for which the patient is included - diffuse lesions of the white matter Fazekas a score of> 2 (periventricular or subcortical) - Contraindications to MRI
  -  For participants control : No history neurosurgical - No history of head trauma with loss of consciousness - not known neurological disease - not known psychiatric illness - No psychotropic treatment

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Glioblastoma Platelet Activation Study

Summary: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
  Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Detailed description: Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (M2) phenotype.
  Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Eligibility: Inclusion Criteria:
  -  MR-morphological suspicion for glioblastoma
  -  informed consent
  Exclusion Criteria:
  -  no informed consent

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: MRI Detection of Microbleeds in Glioma Patients

Summary: Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.


Eligibility: Inclusion Criteria:
  -  Adult patients
  -  Diagnosed with brain glioblastoma
  -  Receiving treatment with cranial radiotherapy and/or chemotherapy
  -  Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence
  Exclusion Criteria:
  -  Underage
  -  Absence of formal diagnosis of glioblastoma
  -  No available medical imaging file with MRI susceptibility weighted imaging sequence

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: FDG PET/CT in Monitoring Very Early Therapy Response in Patients With Glioblastoma

Summary: This pilot clinical trial studies fluordeoxyglucose (fludeoxyglucose) F-18 (FDG) positron emission tomography (PET)/computed tomography (CT) in monitoring very early therapy response in patients with glioblastoma. Diagnostic procedures, such as FDG PET/CT, may help measure a patient's response to earlier treatment. Chemotherapy can induce very rapid changes to the tumor's glucose consumption which can be measured with imaging. FDG PET/CT shortly after the start of therapy may help identify very early therapy response in patients with glioblastoma.

Detailed description: PRIMARY OBJECTIVES:
  I. To assess very early response to therapy in glioblastoma patients using 18F-FDG PET/CT.
  II. Evaluate very early changes in FDG uptake within 48 hours of start of therapy and correlate them with objective response parameters such as Response Assessment in Neuro-Oncology (RANO) and survival.
  OUTLINE:
  Patients undergo standard FDG PET/CT scan 6-8 weeks before start of chemotherapy and one additional FDG PET/CT scan within 48 hours of the start of chemotherapy.

Eligibility: Inclusion Criteria:
  -  Patients with histologically proven high grade glioma
  -  Intention to start therapy
  Exclusion Criteria:
  -  Severe psychiatric illness
  -  Inability to give written consent
  -  Breast feeding / pregnancy

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: uPAR-PET/MRI in Glioblastoma Multiforme

Summary: The purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (uPAR) Positron Emission Tomography (PET) / MRI molecular imaging of glioblastoma.

Detailed description: 68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. 68Ga-NOTA-AE105 PET/MRI will be applied in patients suspected of glioblastoma multiforme. The uptake of the radioligand 68Ga-NOTA-AE105 will be compared and correlated with expression of the molecular target: uPAR using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. In addition, the semiquantitative uptake (standard uptake values, SUVs) of 68Ga-NOTA-AE105 in tumor tissue will be correlated with overall survival and progression free survival

Eligibility: Inclusion Criteria:
  -  Patients where imaging with MRI or CT is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery
  -  The participants must be capable of understanding and giving full informed written consent
  -  age above 18 years
  Exclusion Criteria:
  -  Pregnancy
  -  Lactation/breast feeding
  -  Age above 85 years old
  -  Weight above 140 kg
  -  Known allergy towards 68Ga-NOTA-AE105

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

Summary: This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer.
  The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups:
  -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30)
  -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30)
  -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30)
  The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of HR-negative, HER2-negative (TNBC) breast cancer
  -  Available TNBC diagnostic tumor tissue (archived tissue allowed)
  -  Measurable disease as defined by RECIST, Version 1.1
  -  ECOG performance status 0 to 1
  -  Adequate organ function
  -  Predicted life expectancy of 3 or more months
  Exclusion Criteria:
  -  More than 1 prior chemotherapy regimen for locally recurrent or metastatic TNBC
  -  Prior treatment of locally recurrent or metastatic breast cancer with gemcitabine, carboplatin, or cisplatin (previous adjuvant/neoadjuvant chemotherapy with carboplatin, cisplatin, or gemcitabine is allowed if ≥ 12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy administration and first documented local or distant disease recurrence)
  -  Less than 12 months between date of last adjuvant chemotherapy administration (with curative intent) and first documented local or distant disease recurrence.
  -  Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
  -  Investigational drug within 30 days of first trilaciclib (G1T28) dose
  -  Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose
  -  Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose
  -  Prior hematopoietic stem cell or bone marrow transplantation

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma

Summary: Study Design - Multicenter, open-label, 3 arms, stepwise, phase Ⅱa clinical trial
  Study objective:
  1. Primary - To evaluate the safety of TTAC-0001 in patients with recurrent glioblastoma.
  2. Secondary - To determine the efficacy of TTAC-0001 in patients with recurrent glioblastoma.
  3. Exploratory
  -  To evaluate pharmacokinetic (PK) parameters of TTAC-0001 in patients with recurrent glioblastoma
  -  To evaluate pharmacodynamic (PD) parameters by clinical biomarker test
  Study Methodology
  Patients will be sequentially enrolled from the 1st arm. An enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other Dose Limiting Toxicities (DLT). A safety review committee (SRC) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case.
  A patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. Patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (PD) or the withdrawal of consent.


Eligibility: Inclusion Criteria:
  -  Both male and female patients ≥19 years old
  -  Diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (MRI) scans after concomitant temozolomide chemotherapy with radiotherapy (CCRT). One previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable.
  -  At least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (RANO) criteria
  -  Karnofsky Performance Status (KPS) ≥ 80
  -  A person who satisfies the following criteria in hematologic, renal, and hepatic function tests
  -  At least 12 weeks of expected survival time
  -  Signed informed consent
  Exclusion Criteria:
  -  Diagnosed with other malignant tumor within 2years
  -  Uncontrolled HT or seizure, class III or IV heart failure, oxygen dependent disease, active psychiatric disorder
  -  Not recovered grade 2 AE due to previous CCRT
  -  Major surgery or other investigational drug treatment within 4 weeks
  -  Pregnant/lactating female and female/male potential childbearing without contraception
  -  Severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug
  -  Expectation of poor compliance
  -  Previous therapy with VEGF targeted agent

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

Summary: This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.


Eligibility: Inclusion Criteria:
  -  Histologically confirmed GBM (WHO grade IV).
  -  The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
  -  Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) [as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
  -  Karnofsky performance status (KPS) of at least 60%.
  -  Willing to remain abstinent from consuming alcohol.
  -  Recovered from the toxic effects of prior therapy to < grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
  -  Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
  -  11. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  Exclusion Criteria:
  -  Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
  -  Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
  -  Received more than one course of radiation therapy or more than a total dose of 75 Gy.
  -  History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
  -  Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
  -  Fever within 3 days prior to study enrollment.
  -  Active or severe hepatic or renal disease.
  -  Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
  -  History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
  -  History of Wilson's disease.
  -  History of hemochromatosis.
  -  Pregnant or breastfeeding.

Relevance to patient case: not relevant
Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: INtraoperative photoDYnamic Therapy of GliOblastoma

Summary: The study pilot evaluate the feasibility of a "5-ALA- PpIX (protoporhyrin IX) mediated per-PDT protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. This treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol Stupp


Eligibility: Inclusion Criteria:
  1. Patient male or female ≥18 years
  2. General status (WHO) of Performance status 0, 1 or 2
  3. Probable glioblastoma according to clinical and radiological criteria,
  4. whose surgical indication was given in Multidisciplinary consultation meeting (RCP) of neurooncology,
  5. Decision to treat the patient as part of the Clinical trial also taken in neuro-oncology RCP ("Multidisciplinary consultation meeting")
  6. Patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life
  7. Clinical neuro-oncological monitoring and long-term MRI scheduled at the hospital CHRU of Lille, center of reference of the region
  8. Patient able to understand and sign voluntarily Informed consent
  9. Patient able to adhere to the visit's calendar of the study and other imperatives of the protocol
  10. Women of child-bearing potential should benefit of an effective contraception
  11. For patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ALA
  12. Patient assigned to an heath insurance
  Exclusion Criteria:
  1. Contraindications to 5-ALA (Gliolan®) and to per-operative PhotoDynamic Therapy "perPDT":
  2. Contraindications to 5-ALA
  -  Porphyria
  -  Taking photosensitizer treatment
  -  Severe renal or hepatic impairment
  -  Bilirubin> 1.5 x maximum level, Alkaline Phosphatases and transaminases (ASAT)> 2.5 x Maximum. rates
  -  Creatinine clearance <30 mL / min;
  -  Non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization
  3. Contraindications to surgery
  4. Contraindications to magnetic resonance imaging (MRI)
  5. Treatment with an experimental drug within 30 Days prior to the start of the study
  6. Clinical follow-up impossible to perform for psychological, familial, social or geographical reasons,
  7. Legal incapacity (persons deprived of their liberty or Guardianship or guardianship),
  8. Pregnant or nursing women
  9. Refusal to participate or sign the consent of the study
  10. Soy allergy

Relevance to patient case: not relevant