Brain Tumor AdultNCT04113278
Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma
An observational study of Brain Tumor Adult, run by sohaila Essam.
Trial summary
The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- FGL2 immunohisyochemistry
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Sep 2021
- Phase
- Observational
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression
Who may be able to join
- Pateints>18 years old
- Pathologically proven high grade glioma
- Total or subtotal resection of the tumor
- Patients received concurrent radiation therapy with temozolomide followed by adjuvant temozolamide for 6 months
Who cannot join
- Pregnancy
- Breast feeding
- Other comorbidity
- Previous malignancy or radiation therapy or chemotherapy
Trial locations and contacts
No sites are listed yet.
About this study
The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression
Read the detailed description
Glioblastoma is the most common malignant primary brain tumor in adults, and despite aggressive treatment, it is incurable Patient prognosis differs considerably within the different World Health Organization (WHO) grades, poorest prognosis for patients with the grade IV tumour- the glioblastoma multiform (GBM).
Fibrinogen-like protein 2 (FGL2),regulates both innate and adaptive immunity. FGL2 is a 439 amino acid secreted protein that is similar to the β- and γ-chains of fibrinogen.
Secreted FGL2 (sFGL2) is the key regulator in immunosuppression may play important role in malignant transformation of low to high by inhibiting the proliferation of T cell Study the role of fibrinogen-like protein2 on Immunosuppression and progression ，free survival and overall survival in high grade glioma
- Conditions
- Brain Tumor Adult
- Being tested
- FGL2 immunohisyochemistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGL2 immunohisyochemistryGenetic
Correlation between FLG2 expression and progression free survival and overall surviv
What is being measured
The primary outcome is the main question the study is designed to answer.
Rple of FGL2in high grade glioma as aprognostic factor
Correlation between FLG2 expression and progression free survival and overall survival
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sohaila Essam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sohaila Essam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113278
- Sponsor's protocol ID
- FGL2 in brain cancer
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latha K, Yan J, Yang Y, Gressot LV, Kong LY, Manyam G, Ezhilarasan R, Wang Q, Sulman EP, Eric Davis R, Huang S, Fuller GN, Rao A, Heimberger AB, Li S, Rao G. The Role of Fibrinogen-Like Protein 2 on Immunosuppression and Malignant Progression in Glioma. J Natl Cancer Inst. 2019 Mar 1;111(3):292-300. doi: 10.1093/jnci/djy107.
PubMed 29947810Yan J, Zhao Q, Gabrusiewicz K, Kong LY, Xia X, Wang J, Ott M, Xu J, Davis RE, Huo L, Rao G, Sun SC, Watowich SS, Heimberger AB, Li S. FGL2 promotes tumor progression in the CNS by suppressing CD103+ dendritic cell differentiation. Nat Commun. 2019 Jan 25;10(1):448. doi: 10.1038/s41467-018-08271-x.
PubMed 30683885
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fibirnogen Like Protein 2 as Aprognostic Factor in High Grade Glioma
- ClinicalTrials.gov ID
- NCT04113278
- Acronym / sponsor ID
- FGL2 in brain cancer
- Conditions
- Brain Tumor Adult
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- sohaila EssamUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 2 Oct 2019 (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.
The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression
Detailed description
Glioblastoma is the most common malignant primary brain tumor in adults, and despite aggressive treatment, it is incurable Patient prognosis differs considerably within the different World Health Organization (WHO) grades, poorest prognosis for patients with the grade IV tumour- the glioblastoma multiform (GBM).
Fibrinogen-like protein 2 (FGL2),regulates both innate and adaptive immunity. FGL2 is a 439 amino acid secreted protein that is similar to the β- and γ-chains of fibrinogen.
Secreted FGL2 (sFGL2) is the key regulator in immunosuppression may play important role in malignant transformation of low to high by inhibiting the proliferation of T cell Study the role of fibrinogen-like protein2 on Immunosuppression and progression ，free survival and overall survival in high grade glioma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population was selected from high grade glioma pateints attending the Department of Clinical Oncology, Assiut University hospital during the period from December 2018 to September 2020, we analyzed human high grade gliomas paraffin block for FLG2 expression
Key inclusion criteria (4 listed)
- Pateints>18 years old
- Pathologically proven high grade glioma
- Total or subtotal resection of the tumor
- Patients received concurrent radiation therapy with temozolomide followed by adjuvant temozolamide for 6 months
Key exclusion criteria (4 listed)
- Pregnancy
- Breast feeding
- Other comorbidity
- Previous malignancy or radiation therapy or chemotherapy
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 |
|---|---|---|
| FGL2 immunohisyochemistryCorrelation between FLG2 expression and progression free survival and overall surviv | Genetic | – |
Primary outcome
Rple of FGL2in high grade glioma as aprognostic factor
Time frame: baseline
Correlation between FLG2 expression and progression free survival and overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 29947810Latha K, Yan J, Yang Y, Gressot LV, Kong LY, Manyam G, Ezhilarasan R, Wang Q, Sulman EP, Eric Davis R, Huang S, Fuller GN, Rao A, Heimberger AB, Li S, Rao G. The Role of Fibrinogen-Like Protein 2 on Immunosuppression and Malignant Progression in Glioma. J Natl Cancer Inst. 2019 Mar 1;111(3):292-300. doi: 10.1093/jnci/djy107.
- Background: PubMed 30683885Yan J, Zhao Q, Gabrusiewicz K, Kong LY, Xia X, Wang J, Ott M, Xu J, Davis RE, Huo L, Rao G, Sun SC, Watowich SS, Heimberger AB, Li S. FGL2 promotes tumor progression in the CNS by suppressing CD103+ dendritic cell differentiation. Nat Commun. 2019 Jan 25;10(1):448. doi: 10.1038/s41467-018-08271-x.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor Adult, run by sohaila Essam.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact samir shehata, professor (01222302375, Samir-eid@Hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rple of FGL2in high grade glioma as aprognostic factor (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113278, which also lists 2 linked publications.
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 2 Oct 2019.