GlioblastomaBi-GLAMNCT03115138
Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
A study testing Correlation between molecular anomalies of the primary tumor and circulating tumor DNA in people with Glioblastoma and Molecular Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Molecular Disease
- What is being tested?
- Correlation between molecular anomalies of the primary tumor and circulating tumor DNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2016to 6 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with grade IV glial tumor (glioblastoma according to WHO criteria) for which an indication of surgical excision with radiochemotherapy was chosen at a specialized multidisciplinary meeting of neuro-oncology at the CHU Amiens-Picardy.
- Patients should:
- be able to be followed at the CHU of Amiens throughout their treatment,
- be at least 18 years of age,
- be informed (or trusted) of the conditions and objectives of the study,
- having given their free and informed consent in writing,
- have a life expectancy of more than 6 months,
- be affiliated to a social security scheme.
Who cannot join
- Patients with recurrent tumors.
- Patients supported for another histology.
- Medical, psychological or social conditions that do not allow for proper understanding of the procedures inherent in the study.
- Patients under tutelage, curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.
It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.
- Conditions
- Glioblastoma, Molecular Disease
- Being tested
- Correlation between molecular anomalies of the primary tumor and circulating tumor DNA
- Keywords
- Biopsy
- Medical subject headings
- Glioblastoma, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correlation between molecular anomalies of the primary tumor and circulating tumor DNAOther
The presence of a specific abnormality initially identified on the primary tumor and which can be quantified in the cDNA during the management will allow a better follow-up of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with glial tumor | Other | Not described Receives: Other: Correlation between molecular anomalies of the primary tumor and circulating tumor DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start9 Mar 2016
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Why it stopped: investigator choice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115138
- Sponsor's protocol ID
- PI2015_843_0029
- Acronym
- Bi-GLAM
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.
- ClinicalTrials.gov ID
- NCT03115138
- Acronym / sponsor ID
- Bi-GLAM / PI2015_843_0029
- Conditions
- Glioblastoma, Molecular Disease
- Keywords
- Biopsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: investigator choice
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Mar 2016 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Glioblastomas (GBM) are rare tumors of poor prognosis and their treatment is based on surgery followed by radiochemotherapy. Clinical and imaging evaluation is not always straightforward: the more or less complete surgery, the pseudo-progression after radiochemotherapy, the radionecrosis, the diagnosis of the relapse and the follow-up under anti-angiogenic can pose problems Clinicians and radiologists. Accessibility to a plasma tumor molecular marker would greatly facilitate the follow-up of these patients.
It is now established for many cancers that circulating tumor DNA (cTNA) has the same molecular abnormalities as those identified in the primary tumor cells. Numerous studies have shown the prognostic value and diagnosis of the exploration of cDNA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with glial tumor | Other | Other: Correlation between molecular anomalies of the primary tumor and circulating tumor DNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with grade IV glial tumor (glioblastoma according to WHO criteria) for which an indication of surgical excision with radiochemotherapy was chosen at a specialized multidisciplinary meeting of neuro-oncology at the CHU Amiens-Picardy.
- Patients should:
Key exclusion criteria (4 listed)
- Patients with recurrent tumors.
- Patients supported for another histology.
- Medical, psychological or social conditions that do not allow for proper understanding of the procedures inherent in the study.
- Patients under tutelage, curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correlation between molecular anomalies of the primary tumor and circulating tumor DNAThe presence of a specific abnormality initially identified on the primary tumor and which can be quantified in the cDNA during the management will allow a better follow-up of the patient. | Other | Patients with glial tumor |
Primary outcome
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA
Time frame: 1 year
Results and safety
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Correlation between molecular anomalies of the primary tumor and circulating tumor DNA in people with Glioblastoma and Molecular Disease, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: investigator choice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a correlation between the molecular abnormalities of the primary tumor and the circulating tumor DNA (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.