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Trial Title:
Radiogenomics in Glioblastoma: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
NCT ID:
NCT05541042
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Observational only
Description:
This is an observational study
Arm group label:
patients with glioblastoma
Summary:
The purpose of this study is to evaluate relationships between multiparametric imaging
biomarkers and genetic analysis in glioblastoma patients.
Detailed description:
To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and
genetic analysis (tumor tissues and ctDNA in tumor in situ fluid) in glioblastoma
patients
Criteria for eligibility:
Study pop:
adult patients with glioblastoma
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Written informed consent and HIPAA authorization obtained from the subject/legal
representative prior to performing any protocol-related procedures, including
screening evaluations
- Subjects must be willing and able to comply with scheduled visits, treatment
schedule, laboratory testing, and other requirements of the study
- Histologically confirmed diagnosis of glioblastoma
- Resection surgery done at the study center (Henan Provincial People's Hospital),
with an reservoir intraoperatively implanted connecting the surgical cavity and the
subscalp for postoperative noninvasive TISF collection
- Able to tolerable PET/CT and CT imaging required by protocol
- Karnofsky performance status (KPS) of 70 or higher
Exclusion Criteria:
- Any serious or uncontrolled medical disorder that, in the opinion of the
investigator, may increase the risk associated with study participation or study
drug administration, impair the ability of the subject to receive protocol therapy,
or interfere with the interpretation of study results
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo,
type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
requiring hormone replacement, psoriasis not requiring chronic and systemic
immunosuppressive treatment, or conditions not expected to recur in the absence of
an external trigger are permitted to enroll. Subjects have any other condition
requiring systemic treatment with corticosteroids or other immunosuppressive agents
within 14 days. Inhaled or topical steroids and adrenal replacement doses >10mg
daily prednisone equivalent are permitted in absence of active autoimmune disease
- Clinically significant (i.e., active) cardiovascular disease, for example
cerebrovascular accidents ≤ 6 months prior to study enrollment, myocardial
infarction ≤ 6 months prior to study enrollment, unstable angina, New York Heart
Association (NYHA) Grade II or greater congestive heart failure (CHF), or serious
cardiac arrhythmia uncontrolled by medication or potentially interfering with
protocol treatment
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or
recent arterial thrombosis) within 6 months prior to start of study treatment. Any
previous venous thromboembolism ≥ NCI CTCAE Grade 3 within 3 months prior to start
of study treatment
- History or evidence of inherited bleeding diathesis or significant coagulopathy at
risk of bleeding (i.e., in the absence of therapeutic anticoagulation)
- Current or recent (within 10 days of study enrollment) use of anticoagulants that,
in the opinion of the investigator, would place the subject at significant risk for
bleeding.
- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Provincial People's Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Start date:
December 1, 2022
Completion date:
November 1, 2027
Lead sponsor:
Agency:
Henan Provincial People's Hospital
Agency class:
Other
Source:
Henan Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05541042
