RECRUITING

Endometriosis Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Aim 1. To determine the factors contributing to pain in patients with chronic pelvic pain with and without endometriosis Aim 2. To determine the changes following endometriosis lesion removal surgery in pain and sex hormone levels. Aim 3. To identify factors predicting clinical pain reduction after lesion removal surgery. Additional exploratory aims might compare subgroups of patients such as patients with vs. without endometriosis, with vs. without additional chronic pain syndromes, and with vs. without hormonal treatment. In addition, the role of lesion-specific immune signatures and psychological factors on pain will be explored. Patients with pelvic pain potentially due to endometriosis will complete questionnaires including social, health, behavioral, and psychological questionnaires. Patients will also complete a 2.5 hours study visit of psychophysical assessments of thermal and pressure stimuli. In addition, blood, urine, and saliva samples will be collected for hormonal, immune, and genetic analyses. Additional samples might be collected and stored for future analyses. For some participants, these procedures will be completed several times, including before the surgery as well as 3 months, 6 months and 1 year after surgery. After the surgery, surveys assessing pain and other symptoms will be sent every week on the first month and then monthly for 1 year. In addition, during the surgery, biopsies will be collected and analyzed to determine hormonal, immune and genetic factors. For adolescents, a parent/legal guardian will be asked to assist in completing some of the health-related surveys (i.e., physical developmental survey, health survey, migraine history survey).

Official Title

The Mechanisms Underlying Endometriosis Pain

Quick Facts

Study Start:2023-09-29
Study Completion:2029-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06101303

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with pelvic pain with and without endometriosis scheduled for an operative laparoscopic surgery for endometriosis diagnosis and/or treatment
  2. * Age 12-45
  3. * Females
  1. * Pregnancy
  2. * Planned hysterectomy or oophorectomy
  3. * Co-occurring vaginismus and/or vulvodynia
  4. * For patients aged 12-17 not having a parent/legal guardian willing to sign the consent and answer surveys about their child's health

Contacts and Locations

Study Contact

Alana McMichael, MA
CONTACT
314-273-6194
painlab@wustl.edu
Hadas Nahman-Averbuch
CONTACT
314-273-6194

Principal Investigator

Hadas Nahman-Averbuch, PhD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Hadas Nahman-Averbuch, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29
Study Completion Date2029-09-01

Study Record Updates

Study Start Date2023-09-29
Study Completion Date2029-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pelvic Pain
  • Endometriosis