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Does Immunotherapy Have a Role in the Management of Endometriosis?

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

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 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 : March 2018
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis


Intervention Details:
  • Other: immunohistochemical staining
    immunohistochemical staining


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



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

Responsible Party: Hale GOKSEVER CELIK, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03464799     History of Changes
Other Study ID Numbers: KanuniSSRTH
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female