Molecular genetic, host-derived and clinical determinants of long-term survival in glioblastoma (ETERNITY).

Recruiting

• Conditions: glioblastoma; malignant primary brain tumor; 10029211

• Registration Number: NL-OMON54791
• Lead Sponsor: European Organisation for Research in Treatment of Cancer (EORTC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 73

Inclusion Criteria

Patients:
- Age > 18 years at diagnosis
- Histopathological diagnosis of glioblastoma (reference histology available)
- Survival >5 years from diagnosis
- Availability of tumor tissue from initial glioblastoma diagnosis (FFPE or
fresh-frozen) to validate the diagnosis centrally
- Signed consent form (living patients) or no documentation of previous
objection of the patient to any of these purposes, and the meaningful aim of
the data / material collection and use to research (deceased patients), and a
notification to an ethics committee for the re-use of these data and samples,
and any other national requirements

Caregivers:
- Optional stool collection for in-living caregivers:
* > 18 years old
* In-living caregiver (spouse, in-living family members, in-living
housekeeper)
* Exposed to same environment and share meals at a regular basis with patient
* The patient that the caregiver is taking care of, has provided or will
provide a stool sample
* The patient has consented to contact the caregiver for the project.
- Optional caregiver questionnaires for in-living caregivers or close
caregivers:
* > 18 years old
* The patient has consented to contact the caregiver for the project
* In-living caregiver (spouse, in-living family members, in-living
housekeeper) or close caregiver (not in-living family member, not in-living
housekeeper)

Exclusion Criteria

Optional stool collection for in-living caregivers
- Cancer in the past 3 years (carcinomas in situ in the past 3 years are
allowed)
- IBD (Inflammatory Bowel Disease) e.g. Crohn, Colitis Ulcerosa
- Medications for gastro-intestinal motility within the last 3 months
- Systemic Antibiotics within the last month
- Systemic corticosteroids
- Previous extensive gastro-intestinal surgery
- Use of probiotics containing live bacteria or yeast
- Consent of another caregiver of the same patient

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) patient characteristics and (host)-related factors<br /><br>2) identification of molecular tumor characteristics<br /><br>3) therapy-related parameters including (neuro)toxicity<br /><br>4) immunological studies</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>