Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

Predicting Response Patterns to Treatment in Glioblastoma (GBM) Oncology Patients Based on Host Response Evaluation During Anti-cancer Treatments

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04219475

Acronym

PROPHETIC

Enrollment

1000

Registered

2020-01-07

Start date

2023-01-31

Completion date

2025-12-31

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Brief summary

PROPHETIC GBM - Predicting response patterns to treatment in Glioblastoma (GBM) oncology patients based on host response evaluation during anti-cancer treatments

Detailed description

The goal of this research study is identify new host response proteins, pathways and mechanisms that are associated with responsiveness to GBM treatment modalities. This will serve as a tool for physicians when making treatment decisions. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide up to 5 blood samples and clinical data will be collected from their medical records. The data obtained from the blood samples and the medical records of the patients will be used to search for potential mechanisms that are involved in response to treatment, and to identify potential targets to increase the response, and hence, increase treatment effectiveness or suggest potential new treatments.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Provision of informed consent prior to any study-specific procedures. 2. Male or female aged at least 18 years. 3. KPS not less than 50. 4. Normal hematologic, renal and liver function: 1. Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL; 2. Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min; 3. Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit. 5. Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.

Exclusion criteria

1. Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening. 2. Participation in another clinical trial which includes an investigational drug. 3. Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study. 4. Pregnancy.

Design outcomes

Primary

Measure	Time frame	Description
Response to treatment	One month after completion of TMZ + RT	complete remission (CR); partial remission (PR), stable disease (SD), progressive disease (PD), suspected pseudo-progression, as defined by RANO
Blood levels of proteins	Pre-chemoradiation therapy - 7 days or less before the first administration	Blood levels of proteins representing the Host response at baseline

Secondary

Measure	Time frame	Description
OS	Until death or 3 years	Overall survival
PFS	up to 3 years	Progression free survival

Countries

Israel

Outcome results