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

Clinical trial: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

Summary: This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.
  In addition, this is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.


Eligibility: Inclusion Criteria:
  1. Must have a clinical diagnosis of Glioblastoma (GBM)
  2. Must have a confirmed Epidermal growth factor receptor amplification in tumor tissue
  3. Must have a Karnofsky Performance Status (KPS) performance score of 70 - 100 (N/A to the sub-study)
  4. Must have recovered from effects of surgery, postoperative infection and other complications of surgery
  5. Must have adequate bone marrow, renal, and hepatic function (For the sub-study, the subject must have adequate bone marrow and renal function and have mild-to-moderate hepatic impairment)
  Exclusion Criteria:
  1. Multifocal, recurrent or metastatic Glioblastoma (GBM) or gliomatosis cerebri (For the sub-study, the subject can have multifocal GBM and gliomatosis cerebri but can't have recurrent or metastatic GBM )
  2. Prior chemo therapy or radiosensitizer for head and neck cancer.
  3. Prior radiotherapy to the head or neck in overlap of radiation fields.
  4. Prior therapy for glioblastoma or other invasive malignancy.
  5. Prior, concomitant or planned treatment with Novo-TTF, EGFR-targeted therapy, bevacizumab, Gliadel wafers or other intratumoral or intracavity anti-neoplastic therapy.

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

Clinical trial: Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

Summary: This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine the accuracy of dose delivery and patient comfort with treatment time.
  II. To evaluate normal tissue dose volume statistics and compare to standard planning.
  OUTLINE:
  Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.
  After completion of study treatment, patients are followed up at 6 weeks.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed primary glioblastoma multiforme (GBM)
  -  Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
  -  Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
  -  Karnofsky Performance Status (KPS) >= 70
  -  Ability to understand and willingness to sign a written informed consent
  -  If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment
  -  For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)
  Exclusion Criteria:
  -  Patients with active infection
  -  Patients with KPS < 70 and/or unable to tolerate potentially longer treatment times
  -  Refusal to sign informed consent
  -  Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
  -  Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible

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

Clinical trial: Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery

Summary: This pilot clinical trial studies the correlation between the genetics and brain images of patients with newly diagnosed glioblastoma before surgery. The genetic characteristics of a tumor are an important way to predict how well it will respond to treatment. Imaging, using magnetic resonance imaging (MRI), takes detailed pictures of organs inside the body, and may also provide information that helps doctors predict how brain tumors will respond to treatment. If MRI can provide doctors with similar information about the tumor as the tumor's genes, it may be able to be used to predict tumor response in patients whose tumors cannot be reached by surgery or biopsy to get tissue samples.

Detailed description: PRIMARY OBJECTIVES:
  I. Determine the correlation between the genetic and neuroimaging signature of glioblastoma.
  II. Determine the correlation between the neuroimaging signature of glioblastoma and prognosis.
  OUTLINE:
  Patients undergo MRI before and after gadolinium contrast administration, including 3-dimensional (3D) volumetric T1-weighted sequence, fluid attenuated inversion recovery (FLAIR) sequence, diffusion weighted imaging, and perfusion MRI. Tissue samples are also analyzed for the tumor genetic profile.

Eligibility: Inclusion Criteria:
  -  Patients who will be undergoing surgery for newly-diagnosed glioblastoma
  -  Subtotal, gross total or biopsy patients will be eligible
  -  Confirmation of pathology as glioblastoma
  Exclusion Criteria:
  -  Tissue analysis demonstrating pathology other than glioblastoma
  -  Patients with a contraindication to having MR imaging (e.g. pacemaker) or contrast MR administration (e.g. hypersensitivity to gadolinium or renal insufficiency above the institutional threshold for administration of contrast); patients with hypersensitivity to MR contrast may be able to participate if it has been established that premedication will mitigate the hypersensitivity reaction

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

Clinical trial: Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

Summary: This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.

Detailed description: The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

Eligibility: Inclusion Criteria:
  -  Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
  -  Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
  -  Life expectancy of greater than 3 months
  -  Patients scheduled for standard therapy (6 weeks radiation treatment (RT) ~ 60 Gy, plus temozolomide 75 mg/m^2 during 6 week RT, and followed routine monthly temozolomide therapy)
  -  Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
  Exclusion Criteria:
  -  Patients who underwent complete resection
  -  Patients with no evidence of measurable disease after surgery
  -  Patients who have had chemotherapy or radiotherapy
  -  Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
  -  Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
  -  For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

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

Clinical trial: Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid

Summary: The purpose of GLIOPLAK is to evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. The studied parameter is the variation in platelet count during the radio-chemotherapy phase. The main objective is to identify early in Stupp protocol a group of patients having high risk to undergo thrombocytopenia in maintenance phase of temozolomide. With this result an algorithm of platelet monitoring for patients treated with Stupp protocol wil be proposed.

Detailed description: Glioblastoma is the most common primitive cerebral tumor. Currently its optimal treatment is based on a multidisciplinary approach combining an initial surgical resection, if feasible, then Stupp protocol. Stupp protocol consists of two phases: first phase involves external radiotherapy with concomitant oral temozolomide at a dose of 75mg/m2 per day for about six weeks. After 4 weeks of therapy break, maintenance phase begins with temozolomide alone, for a period of 6 cycles (1 cycle = 5 days over 28). The dose of temozolomide is 150mg/m2 on the first cycle followed by 200 mg/m2. One major limiting toxicity of temozolomide is hematologic, especially thrombocytopenia. They occur in around 15 and 20% of patients in maintenance phase. Thrombocytopenia has an impact on the schedule of Stupp protocol such as dose reduction or even early discontinuation. Currently no predictive marker of thrombocytopenia in the maintenance phase was identified. Such marker could be of major interest to adapt biological and clinical follow-up by patient in maintenance phase. We conduct a retrospective analysis on a cohort of patients suffering from glioblastoma and treated with Stupp protocol. We found that a decrease in platelet count during the radio-chemotherapy phase could be highly predictive of protocol changes in maintenance phase of temozolomide due to thrombocytopenia. The main objective of GLIOPLAK is to prospectively confirm the predictive value of this test and to evaluate the prognostic impact of the occurrence of thrombocytopenia <100,000/mm3. Secondary objective of GLIOPLAK are to describe all limiting toxicities in maintenance phase, to constitute a prospective biological collection and to collect biological samples to perform pharmacological analysis (pharmacogenomics and pharmacokinetics parameters).

Eligibility: Inclusion Criteria:
  -  Age Superior to 18 years
  -  Inform consent form signed
  -  Newly diagnosed (histologically) glioblastoma
  -  Stupp protocol treatment
  -  with social insurance
  Exclusion Criteria:
  -  Not inform consent form signed
  -  participation to another clinical trial
  -  other cancer
  -  background of hematological pathology
  -  patient under guardianship, curatorship

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

Clinical trial: Cell Cycle Regulatory Gene Study in Patients With Myeloproliferative Disorders

Summary: This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.
  Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.

Detailed description: This study involves observing the level of cell cycle regulatory gene in patients with myeloproliferative disorders(MPD). These disorders include polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) and chronic myeloid leukemia (CML). The abnormal blood and/or bone marrow cells, or materials derived from these abnormal cells, like DNA, RNA, protein or plasma will be used in laboratory studies.
  Cell cycle regulatory protein such as cyclins, cyclin-dependent kinases(Cdks) and Cdk inhibitors(CKIs) play indispensable roles in processes such as transcription, metabolism and stem cell self-renewal. MPD are a group of diseases characterized by abnormally increased proliferation of erythroid, megakaryocytic, or granulocytic cells. The pathogenesis was still unclear. Detecting the level of cell cycle regulatory protein will be useful to look for the possible role in MPD and better understand the cause of MPD.
  In this study, the cell cycle regulatory message RNA and protein from patients' and healthy volunteers' bone marrow and peripheral blood will be extracted and quantified by real time polymerase chain reaction and western blot. The different level of cell cycle regulatory gene between patients and volunteers and the relationship between the level and patients' clinical characteristics such as age, gender, type of disease will be analysed by SPSS.

Eligibility: Inclusion Criteria:
  -  Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF) or chronic myeloid leukemia (CML) as defined by the World Health Organization (WHO) diagnostic criteria
  Exclusion Criteria:
  -  Have received treatment

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

Clinical trial: Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus

Summary: Hydrocephalus is a disturbance of cerebrospinal fluid production, flow and absorption leading to intracranial hypertension. Assessment of the change in intracranial pressure after ventriculoperitoneal shunt surgery is important in guiding appropriate postoperative management. The optic nerve sheath diameter measured using ultrasonography has been verified as a non-invasive indicator of intracranial hypertension in various clinical studies. The investigators hypothesized that a change in optic nerve sheath diameter detected through ultrasonography could help ascertain a reduction in intracranial pressure following ventriculoperitoneal shunt surgery in adult patients without the risk of serious complications.


Eligibility: Inclusion Criteria:
  -  Adult patients (20-90 years of age, ASA physical status 3 or less) who are scheduled for elective ventriculoperitoneal shunt surgery with non-communicating hydrocephalus and communicating hydrocephalus except for normal-pressure hydrocephalus
  -  Non-communicating hydrocephalus is defined as a pattern of ventricular system or at the level of the fourth ventricle's outlets by lesions including tumor, giant aneurysm, or aqueductal stenosis.
  -  Communicating hydrocephalus is defined as paraventricular enlargement resulting from postoperative complication after cranial surgery, meningitis, subarachnoid or intracerebral hemorrhage.
  Exclusion Criteria:
  -  Patients with previous history of shunt operation, ocular disease and ocular surgery
  -  Patients with anatomical or functional abnormality of optic nerve
  -  emergency patient

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

Clinical trial: Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme

Summary: INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.


Eligibility: Inclusion Criteria:
  1. Age ≥18 and ≤ 70 years
  2. Karnofsky Performance Score (KPS) ≥ 60%
  3. Supratentorial T1-Gd enhancing lesion(s) amenable to total resection
  4. Legal capacity and ability of subject to understand character and individual consequences of the clinical trial
  5. Patient's written informed consent obtained at least 24h prior to surgery
  6. For women with childbearing potential: adequate contraception
  7. Patients must have adequate organ functions
  Bone marrow function:
  -  Platelets ≥ 145.000/μL
  -  WBC ≥ 4.000/μL
  -  Hemoglobin ≥ 12.0 g/dL
  Liver Function:
  -  ASAT and ALAT ≤ 1.5 times ULN
  -  ALP ≤ 2.5 times ULN
  -  Total Serum Bilirubin < 1 times ULN
  Renal Function:
  -  Serum Creatinine ≤ 1.5 times ULN
  Inclusion Criteria Related to Surgery:
  8. IORT must be technically feasible
  9. Histologically confirmed (frozen section) GBM (WHO grade IV)
  Exclusion Criteria
  1. Multicentric disease (e.g. in both hemispheres) or non-resectable satellite lesions
  2. Previous cranial radiation therapy
  3. Cytostatic therapy / chemotherapy for cancer within the past 5 years
  4. Use of alternating electrical fields (e.g., Novo-TTF)
  5. History of cancers or other comorbidities that limit life expectancy to less than five years
  6. Previous therapy with anti-angiogenic substances (such as bevacizumab)
  7. Technical impossibility to use MRI or known allergies against MRI and/or CT contrast agents
  8. Participation in other clinical trials testing cancer-derived investigational agents/procedures.
  9. Pregnant or breast feeding patients
  10. Fertile patients refusing to use safe contraceptive methods during the study
  Exclusion Criteria Related to Surgery:
  11. Active egress of fluids from a ventricular defect
  12. In-field risk organs and/or IORT dose >8 Gy to any risk organ

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

Clinical trial: Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

Summary: The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Detailed description: The purpose of the phase I dose escalation part of this study is to estimate the MTD(s) and/or identify the RP2D of the combination treatment of ribociclib+ everolimus + exemestane when dosed continuously in adult men and postmenopausal women with HR+ HER2-negative advanced breast cancer resistant to the non-steroidal aromatase inhibitors, fulvestrant or tamoxifen.
  The purpose of the phase II portion of this trial will be to evaluate the anti-tumor activity of exemestane, everolimus and ribociclib triplet following progression on a CDK 4/6 inhibitor. This part of the study will be conducted using a Simon's optimal two-stage design.

Eligibility: Inclusion Criteria:
  -  Adult men and women
  -  Patient has a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer
  -  Patient must have either measurable disease by RECIST 1.1 or bone lesions in absence of measurable disease.
  -  ECOG Performance Status 0 - 1
  -  Disease refractory to either, AI, tamoxifen or fulvestrant
  -  Previously treated on any CDK 4/6 inhibitor.
  -  Patient has adequate bone marrow and organ function.
  Exclusion Criteria:
  -  Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment.
  -  Patient has received more than one line of chemotherapy for advanced disease.
  -  Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
  -  Progressed on more than one CDK 4/6 inhibitor
  -  Patient with CNS involvement unless they are at least 4 weeks from prior therapy completion.
  -  Clinically significant, uncontrolled heart disease and/or recent cardiac events.

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

Clinical trial: Determination of Immune Phenotype in Glioblastoma Patients

Summary: Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. Despite intensive research efforts and a multimodal management that actually consists of surgery, radiotherapy and chemotherapy with temozolomide, the prognosis is dismal. The aim of the current observational study is to determine immune phenotypes in individual patients with GBM at the time of diagnosis and to correlate tumor size, location (imaging), tumor properties (isocitrate dehydrogenase - 1 (IDH-1), o6-methylguanine-DNA-methyltransferase (MGMT), epidermal growth factor receptor (EGFR) mutation status, etc.) with clinical data, such as progression free and overall survival, Karnofsky index (progression free survival (PFS),overall survival (OS), Karnofsky score( KFS)), with blood immune phenotypes, biomarkers, and immune histochemical results of tumor infiltrating lymphocytes, macrophages, myeloid derived suppressor cells (MDSC), etc.. The different immunological phenotypes could predict a positive response to specific immunological therapeutic strategies and select the individual therapeutic plan for an individual GBM patient.


Eligibility: Inclusion Criteria:
  -  adult glioblastoma multiforme
  Exclusion Criteria:
  -  pregnancy, unable to give consent

Relevance to patient case: not relevant