Radiogenomics in Glioblastoma: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

ConditionGlioblastoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan Provincial People's Hospital

About this trial

The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in glioblastoma patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

adult patients with glioblastoma

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Observational only

    Other intervention

    This is an observational study

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: patients with glioblastoma1 intervention

Trial outcomes

Primary outcomes

1

Functional and genomic profiling of glioblastoma

Prognostic stratification will be evaluated using following parameters: Quantitative and qualitative parameters from CT, PET, MRI Genomic data of glioblastoma tumor samples and tumor in situ fluid samples

Time frame
3 years after diagnosis

Secondary outcomes

1

Relationship between genomic and multiparametric imaging profiling

We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of glioblastoma.

Time frame
3 years after diagnosis

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: