NCT07274956Completed
Nerve Fiber Density in DIE Nodules & Pelvic Pain
Is Pelvic Pain Severity Correlated With Nerve Fiber Density Within DIE Nodules?
Source: ClinicalTrials.gov · Last updated 10 Dec 2025
Brief summary (registry, in English)
Deep infiltrating endometriosis (DIE) is a highly symptomatic form of endometriosis linked to severe dysmenorrhea, dyspareunia, dyschezia, dysuria, and chronic pelvic pain. Histologic studies suggest abundant neural elements in DIE nodules, but the relationship between nodule-level nerve fiber density and patient-reported pelvic pain remains insufficiently defined. This retrospective, cross-sectional study with prospective pathology re-review evaluates whether nerve fiber density in surgically excised DIE nodules correlates with pain severity and location. Women aged 18-55 who underwent surgery for DIE after inadequate response to medical therapy are included. Clinical data (demographics, gynecologic history, prior treatments) and standardized pain scores (VAS for pain domains) are abstracted from records. Archived blocks are recut; sections are stained with H\&E and immunolabeled (e.g., SOX-10) to quantify neural profiles and derive a nerve fiber density metric per nodule. Primary endpoint: association between nerve fiber density and pain intensity/localization. Secondary endpoints: relationships with lesion site/depth and other clinicopathologic variables; exploratory discrimination of severe-pain phenotypes. Statistics (χ²/Fisher, t/Mann-Whitney, Kaplan-Meier/Cox if applicable) use two-sided p\<0.05. This minimal-risk study uses existing records and archived tissue only; findings may inform counseling, nerve-sparing surgical planning, and future biomarker-driven, response-adapted trials.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 65 (actual)
- First submitted
- 28 Nov 2025
- Start date
- 1 Feb 2022
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Diseases
- Endometriosis
- NCT number
- NCT07274956
What you commit to
- Study type: Observational
- Participants enrolled: 65
- From 1 Feb 2022 to the primary completion date, 27 Jun 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Missing preoperative pain assessment (no VAS data within ≤3 months before index surgery)
- Concomitant malignancy of the pelvis/abdominopelvic organs or malignancy treated within the past 5 years
- Prior pelvic radiotherapy or major pelvic/nerve ablative surgery that precludes meaningful pain attribution
Other illness
- Acute pelvic infection at time of assessment or surgery (e.g., PID, tubo-ovarian abscess)
- Primary pain disorders likely to confound attribution (e.g., interstitial cystitis/bladder pain syndrome, IBS with pain as dominant symptom, centrally mediated chronic pain syndromes) without adequate documentation to separate pain sources
Other
- Insufficient biospecimen (no/poor-quality FFPE tissue for H\&E/IHC)
- \-
Who the study is looking for
- Surgically treated for deep infiltrating endometriosis (DIE) with curative intent within the study period
- Histopathologic confirmation of DIE on resected specimen (e.g., rectovaginal septum, uterosacral/cardinal ligaments, parametria, bowel, ureter, bladder, retrocervical/cervicovaginal sites)
- Availability of archived FFPE tissue blocks adequate for H\&E and immunohistochemistry (e.g., SOX10) to quantify nerve fiber density
- Documented preoperative pain assessment (e.g., VAS 0-10 for dysmenorrhea, dyspareunia, dyschezia, dysuria, and/or chronic pelvic pain) obtained within ≤3 months prior to index surgery
- Accessible clinical data in the medical record (demographics, gynecologic history, prior medical/surgical therapies) sufficient for planned analyses
- IRB approval in place; inclusion under written informed consent or IRB waiver applicable to retrospective data/tissue use -
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Basaksehir Cam Ve Sakura Sehir Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.