Diffuse Traumatic Cerebral EdemaPhase 1NCT04414020
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
A Phase 1 study testing Progesteron in people with Diffuse Traumatic Cerebral Edema, run by Minia University at 2 sites in Egypt.
Trial summary
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diffuse Traumatic Cerebral Edema
- What is being tested?
- Progesteron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2020to 30 Sep 2020
- Phase
- Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All elective brain tumors elligible for craniotomy
Who cannot join
- Refusal to participare
- Emergency craniotomy
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Medicine
Al Minyā, Abohelal, 6115
mina raouf, MD, 01015752424, Drmina2015@gmail.com
omaima mohammad, MD, 01061762894, Omayamshehata@yahoo.com
- Recruiting
Faculty of Medicine
Minya, Abohelal, 6115
mina raouf, MD, 01015752424, Drmina2015@gmail.com
omaima mohammad, MD, 01061762894, Omayamshehata@yahoo.com
About this study
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty
Read the detailed description
Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.
- Conditions
- Diffuse Traumatic Cerebral Edema
- Being tested
- Progesteron
- Keywords
- Progesterone, brain tumor, Neuronal biopsy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteronDrug
intramusculer progesterone
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group receiving conventional treatment without progesterone |
| progesterone group | Active comparator | 1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface Receives: Drug: Progesteron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With craniotomy-Related Adverse Events
Degree of microscopic cellular injury and brain odema in brain biopsy
Measured: 3 months
Secondary outcomes (1)
Number of Participants with neuronal deficit
Sensory, motor or autonomic dysfunction
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Traumatic Cerebral EdemaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414020
- Sponsor's protocol ID
- 623-4/2020
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
- ClinicalTrials.gov ID
- NCT04414020
- Acronym / sponsor ID
- 623-4/2020
- Conditions
- Diffuse Traumatic Cerebral Edema
- Keywords
- Progesterone, brain tumor, Neuronal biopsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 4 Jun 2020 (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.
Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty
Detailed description
Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group receiving conventional treatment without progesterone |
| progesterone group | Active comparator | Drug: Progesteron1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All elective brain tumors elligible for craniotomy
Key exclusion criteria (2 listed)
- Refusal to participare
- Emergency craniotomy
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 |
|---|---|---|
| Progesteronintramusculer progesterone | Drug | progesterone group |
Primary outcome
Number of Participants With craniotomy-Related Adverse Events
Time frame: 3 months
Degree of microscopic cellular injury and brain odema in brain biopsy
1 secondary outcome
Number of Participants with neuronal deficit
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progesteron in people with Diffuse Traumatic Cerebral Edema, run by Minia University at 2 sites in Egypt.
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 1 inclusion and 2 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mina Raouf, MD (01015752424, drmina2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With craniotomy-Related Adverse Events (time frame: 3 months). 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 4 Jun 2020.