Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma

NCT04657146 | Suspended DMC

• 1 other identifier: Pro00107040
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.

Conditions

Glioblastoma

Keywords

Glioblastoma, T cells, Sequestration; Sphingosine-1-phosphate receptor 1; β-arrestin, Bone marrow, Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Variations in blood and bone marrow T cell counts

  Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma.

  2 years

• Variations in Sphingosine-1-phosphate receptor 1 (S1P1) levels

  Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with glioblastoma.

  2 years

Study Arms (1)

Patients with suspected newly-diagnosed Glioblastoma (GBM)

Patients, ≥18 years of age, with newly diagnosed GBM, World Health Organization (WHO) Grade IV, undergoing gross total resection (defined as \>90% of contrast enhancing volume removed on post-operative MRI) and collection of blood, bone marrow, and tumor.

Other: Biorepository

Interventions

Biorepository OTHER

Tumor collection (\> 1cm3): Intraoperatively Peripheral blood collection: * Intraoperatively (60mL +/- 5mL) * Post-resection (30mL +/- 5mL) * Post- standard of care treatment (30mL +/- 5 mL) Bone marrow aspiration: * Intraoperatively (10mL +/- 5 mL) * Post-resection (5mL +/- 5 mL) * Post- standard of care treatment (5mL +/- 5 mL)

Patients with suspected newly-diagnosed Glioblastoma (GBM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients meeting the terms of the inclusion and exclusion criteria above will be eligible to participate in the study. This includes all patients over 18 years of age, both sexes, and all minorities. A total of 40 patients will be enrolled in the study. Patients who are not confirmed to have GBM on histopathological analysis, or who do not qualify as gross total resection per the definition above will be removed from the study and replaced until a total of 40 patients is reached.

You may qualify if:

• Age ≥18 years of age.
• Suspected newly-diagnosed GBM, World Health Organization (WHO) Grade IV with intent for gross total resection (as defined above).
• Accessibility for treatment and follow up.
• Patient consent obtained according to Duke institutional policy.
• Women of child bearing potential (WOCBP) must have a negative serum pregnancy test according to standard of care prior to surgery.

You may not qualify if:

• Patients who previously received other conventional therapeutic interventions for newly diagnosed glioblastoma with the exception of surgical intervention.
• Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
• Pregnant or breast-feeding during the study period.
• Patients with an active infection, or febrile within 24 hours of surgery.
• Patients with inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune disease.
• Patients with history of or active hematologic or bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition or polycythemia vera.
• Prior bone marrow harvests preceding this study.
• Patients with known or suspected immunodeficiency or human immunodeficiency virus (HIV).
• Hematocrit \< 24 % pre-operatively.
• Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or comply with protocol.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Tumor collection 2. Peripheral blood sample collection 3. Bone marrow aspiration

MeSH Terms

Conditions

Glioblastoma

Interventions

Biological Specimen Banks

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Anoop Patel, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Katayoun Ayasoufi, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: February 5, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)