RECRUITING

Vaginal Fluid Collection for Detection of Endometrial Cancer

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Conditions

Endometrial Cancer

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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

The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN). The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN.

Official Title

Vaginal Fluid Collection Study for Endometrial Cancer Test Research and Development

Quick Facts

Study Start:2024-02-19
Study Completion:2024-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06294886

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:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women ≥18 years of age.
  2. 2. Women with endometrial tissue biopsy-based histopathological diagnosis of EC (any histology, including uterine carcinosarcoma), AEH or EIN.
  3. 3. Women whose planned surgical intervention (if any) includes hysterectomy, D\&C, or hysteroscopic resection.
  4. 4. Participant understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
  1. 1. Patient with recurrent and/or previously treated EC.
  2. 2. Receipt of preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis prior to study enrollment.
  3. 3. Prior hysterectomy.
  4. 4. Current known pregnancy diagnosis.
  5. 5. Prior or current biopsy and histopathology-proven cervical cancer.
  6. 6. The presence of concomitant biopsy and histopathology-proven cervical dysplasia.
  7. 7. Any prior pelvic or vaginal radiotherapy.
  8. 8. Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years.
  9. 9. Chemotherapy within the past 5 years.
  10. 10. Prior intervention to treat, or surgery with intent to completely remove, the target pathology for the current diagnosis during the current episode.

Contacts and Locations

Study Contact

Wallis Blumm
CONTACT
9172082989
wblumm@innovis.net
Gregg S Britt
CONTACT
3103863000
gbritt@innovis.net

Principal Investigator

Gregg S Britt
STUDY_DIRECTOR
Innovis LLC

Study Locations (Sites)

Trials365
Shreveport, Louisiana, 71118
United States

Collaborators and Investigators

Sponsor: Innovis LLC

  • Gregg S Britt, STUDY_DIRECTOR, Innovis LLC

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 Date2024-02-19
Study Completion Date2024-06-01

Study Record Updates

Study Start Date2024-02-19
Study Completion Date2024-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Endometrial Cancer