NCT07417774

Brief Summary

The goal of this sub-study of the RESTORE trial is to identify biomarkers associated with tumor hypoxia, identify biomarkers that differentiate pseudoprogression from true progression, and correlate biomarkers with clinical outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
55mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Dec 2025Dec 2030

Study Start

First participant enrolled

December 8, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 9, 2026

Last Update Submit

February 13, 2026

Conditions

Glioblastoma (GBM)

Keywords

GlioblastomaLiquid Biopsy

Outcome Measures

Primary Outcomes (1)

  • Tumor hypoxia biomarkers

    Identify differentially expressed tumor hypoxia markers in newly-diagnosed glioblastoma subjects treated with NanO2 versus placebo in the RESTORE study.

    until disease progression and up to 5 years

Secondary Outcomes (2)

  • Biomarker expression

    until disease progression and up to 5 years

  • Relationship between biomarker levels, MGMT methylation status, and survival outcomes

    until disease progression and up to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

RESTORE study participants

You may qualify if:

  • Subjects must be enrolled in the RESTORE study (NCT03862430) and provide written informed consent for the RESTORE LB sub-study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Saint Luke's Cancer Institute

Kansas City, Missouri, 64111, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 18, 2026

Study Start

December 8, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2030

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)