Trial · NCT07893197
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) | From enrolment to safety follow up at week 90 | Response Evaluation Criteria in Solid Tumors (RECIST 1.1) applied to MRIs (Axial, pre- and post- gadolinium-enhanced 3D T1-weighted IR-GRE with \<1mm resolution) at each study visit |
| Primary | Investigator-assessed Overall Response Rate (ORR) | From enrolment to safety follow up at week 90 | Response Evaluation Criteria in Solid Tumors (RECIST 1.1) applied to magnetic resonant imaging (MRIs) (Axial, pre- and post- gadolinium-enhanced 3D T1-weighted IR-GRE with \<1mm resolution) at each study visit |
| Primary | Overall Survival of patients with recurrent grade 1 or 2 meningioma | From enrolment to safety follow up at week 90 | Overall survival is defined as the period from the baseline visit (V1) until death. |
| Secondary | Incidence of Severe Adverse Events related to the study drug | From enrolment to safety follow up at week 90 | Grade of Adverse Events classified as per CTCAE v6.0. The higher the grade, the worse and more severe the event. |
| Secondary | Incidence of Adverse Events related to the study drug | From enrolment to safety follow up at week 90 | Grade of Adverse Events classified as per CTCAE v6.0. The higher the grade, the worse and more severe the event. |
| Secondary | Liver toxicology panel measured in blood (AST, ALT, ALP, total bilirubin) | From enrolment to safety follow up at week 90 | Liver toxicity indicators in blood: Aspertate aminotransferase (AST) (U/L, Reference range: 6-35), Alanine aminotransferase (ALT) (U/L, Reference range: 6-45), total bilirubin (umol/L, 1.7-18.9), alkaline phosphatase (ALP) |
| Secondary | Calcium in blood serum | From enrolment to safety follow up at week 90 | Reference range for calcium concentration in serum: 2.12-2.62 mml/L |
| Secondary | Total White Blood Cell Count in Blood | From enrolment to safety follow up at week 90 | White Blood Cell Count (Reference Range: 4.5-11 10\^9/L). Can be further subdevided into different types of white blood cells including: Neutrophils (1.88-7.7 10\^9/L), Lymphocytes (1-4.8 10\^9/L), Monocytes (0-0.8 10\^9/L), Eosinophils (0-0.45 10\^9/L), Basophils (0-0.022 10\^9/L). |
| Secondary | Serum Lipase | From enrolment to safety follow up at week 90 | Determined in serum. Reference range: 14-45 umol/L |
| Secondary | Urinalysis-Dipstick | From enrolment to safety follow up at week 90 | Dipstick measures several values at once: pH (measured in logarithmic units from 0-14, 7 is normal), amount of protein (Normal reference range: under 10-14 mg/dL), glucose (Normal reference range: 0 to 15 mg/dL or 0 to 0.8 mmol/L), ketones (measured in mmol/L), blood (normal: 3 to 4 red blood cells per high power field), nitrites (measured as positive or negative, no scale), leukocyte esterase (measured in leukocytes per microliter) |
| Secondary | Urinalysis- Visual inspection | From enrolment to safety follow up at week 90 | Determine urine color(normal urine is pale yellow, clarity (normal urine is clear), odor (small, neutral) |
| Secondary | Karnofsky Performance Status | From enrolment to safety follow up at week 90 | Scoring degree of overall abilities and independence as per Shag et al, 1984. Range from "Normal no complaints; no evidence of disease"(100%) to "Dead" (0%) |
| Secondary | Pregnancy test-Quantitative beta hCG in urine | From enrolment to safety follow up at week 90 | Measurement to determine pregnancy status in urine, Reference range: 0-4.9 IU/L. Positive test will lead to trial discontinuation. |
| Secondary | Electrocardiogram | From enrolment to safety follow up at week 90 | Measures electrical activity of the heart looking at electrical timing and wave patterns (changes of voltage over time) |
| Secondary | EORTC QLQ-C30 (Version 3) | From enrolment to safety follow up at week 90 | The 30- question quality-of-life assessment focussing on the well-being and health of the patient. Items 1-28 use a 4-point scale ("Not at All" to "Very Much"); items 29-30 use a 7-point scale ("Very poor" to "Excellent"). |
| Secondary | The Neurologic Assessment in Neuro-Oncology (NANO) scale | From enrolment to safety follow up at week 90 | Assessing the neurologic function of the patient. Scale ranges from "normal" to "None to very little function" following Nayak et. al, 2017. |
| Secondary | Red Blood Cell Count | From enrolment to safety follow up at week 90 | Reference range: 4-5.1 10\^12/L |
| Secondary | Platelet count in blood | From enrolment to safety follow up at week 90 | Refererence range: 140-450 10\^9/L |
| Secondary | Hemoglobin in blood | From enrolment to safety follow up at week 90 | Reference range: Female:120-160 g/L, Male: 135-175 g/L |
| Secondary | body temperature | From enrolment to safety follow up at week 90 | Unit: degrees Celsius, °C |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT07893197/registered