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Does Immunotherapy Have a Role in the Management of Endometriosis?

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ClinicalTrials.gov Identifier: NCT03464799
Recruitment Status : Unknown
Verified August 2018 by Hale GOKSEVER CELIK, Kanuni Sultan Suleyman Training and Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hale GOKSEVER CELIK, Kanuni Sultan Suleyman Training and Research Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Endometriosis Other: immunohistochemical staining

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
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Does Immunotherapy Have a Role in the Management of Endometriosis?
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Groups and Cohorts
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Intervention Details:
  • Other: immunohistochemical staining
    immunohistochemical staining

Outcome Measures
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Primary Outcome Measures :
  1. immunohistochemical staining [ Time Frame: 6 months ]
    immunohistochemical staining with PD-L1


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients operated for endometriosis
Criteria

Inclusion Criteria:

  • patients operated for endometriosis between 2013 and 2014
  • pathological examinations proving the diagnosis of endometriosis

Exclusion Criteria:

  • patients operated for cysts other than endometriosis
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hale GOKSEVER CELIK, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03464799    
Other Study ID Numbers: KanuniSSRTH
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis