EndometriosisNCT03464799
Does Immunotherapy Have a Role in the Management of Endometriosis?
An observational study of Endometriosis, run by Kanuni Sultan Suleyman Training and Research Hospital.
Trial summary
Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. "programmed cell death (PD-1)" is expressed on T cells. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- immunohistochemical staining
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Dec 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients operated for endometriosis
Who may be able to join
- patients operated for endometriosis between 2013 and 2014
- pathological examinations proving the diagnosis of endometriosis
Who cannot join
- patients operated for cysts other than endometriosis
About this study
Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. "programmed cell death (PD-1)" is expressed on T cells. The immunotherapies in which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as very effective in the treatment of many cancers. If these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.
Read the detailed description
40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. Pathological specimens will be stained with an immunohistochemical marker named as PDL-1. "programmed cell death (PD-1)" is a protein containing 288 aminoacids and expressed on T cells. It was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. The upregulation of PD-1 is a result of the activation of T cells and it is necessary for the termination of immune response. PD-L1 is a ligand for PD-1. The immunotherapies in which antibodies against these PD-1 and its ligands (especially PDL-1) provides significant improvements in many cancers such as melanoma. Evidence about the role of these ligands in endometriosis will be an important step in its management.
- Conditions
- Endometriosis
- Being tested
- immunohistochemical staining
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical stainingOther
immunohistochemical staining
What is being measured
The primary outcome is the main question the study is designed to answer.
immunohistochemical staining
immunohistochemical staining with PD-L1
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study startSep 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hale GOKSEVER CELIK, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464799
- Sponsor's protocol ID
- KanuniSSRTH
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Immunotherapy Have a Role in the Management of Endometriosis?
- ClinicalTrials.gov ID
- NCT03464799
- Acronym / sponsor ID
- KanuniSSRTH
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Mar 2018 (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.
Pathological specimens of 40 women that had been operated for endometriosis will be included in this study. These tissues will be stained with a marker named as PDL-1 in pathological examination. "programmed cell death (PD-1)" is expressed on T cells. The immunotherapies in which antibodies against these PD-1 and its ligands (PDL-1) have been used are accepted as very effective in the treatment of many cancers. If these ligands can be shown in the endometriosis, it will be an important step for the treatment of endometriosis.
Detailed description
40 women who had been operated for endometriosis between 2013 and 2014 will be included in this study. Pathological specimens will be stained with an immunohistochemical marker named as PDL-1. "programmed cell death (PD-1)" is a protein containing 288 aminoacids and expressed on T cells. It was shown on apoptotic cells in earlier times, but then it has been understood that its physiologic role is not cell death. The upregulation of PD-1 is a result of the activation of T cells and it is necessary for the termination of immune response. PD-L1 is a ligand for PD-1. The immunotherapies in which antibodies against these PD-1 and its ligands (especially PDL-1) provides significant improvements in many cancers such as melanoma. Evidence about the role of these ligands in endometriosis will be an important step in its management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients operated for endometriosis
Key inclusion criteria (2 listed)
- patients operated for endometriosis between 2013 and 2014
- pathological examinations proving the diagnosis of endometriosis
Key exclusion criteria (1 listed)
- patients operated for cysts other than endometriosis
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 |
|---|---|---|
| immunohistochemical stainingimmunohistochemical staining | Other | – |
Primary outcome
immunohistochemical staining
Time frame: 6 months
immunohistochemical staining with PD-L1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Kanuni Sultan Suleyman Training and Research Hospital.
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 2 inclusion and 1 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 14 Aug 2018. 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?
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?
immunohistochemical staining (time frame: 6 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 14 Aug 2018.