RECRUITING

Developing a Test for the Detection of Ovarian Cancer

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 study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis. Statistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.

Official Title

Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study

Quick Facts

Study Start:2020-04-13
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04794322

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:30 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)
  2. * Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
  3. * Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy
  1. * Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
  2. * Inability to provide informed consent
  3. * Age less than 30 years
  4. * Inability to obtain the minimum amount of blood
  5. * Inability to obtain the minimum amount of uterine lavage sample
  6. * At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL)
  7. * Prior history of known ovarian or endometrial cancer
  8. * Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
  9. * History of untreated high-grade cervical dysplasia (CIN3)
  10. * History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.
  11. * Currently pregnant
  12. * Known Lynch syndrome

Contacts and Locations

Study Contact

Jackie Dahlgren
CONTACT
206 667 3438
jdahlgre@fredhutch.org

Principal Investigator

Christos Patriotis, PhD
STUDY_DIRECTOR
National Cancer Institute (NCI)

Study Locations (Sites)

University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Kaiser Permanente - San Francisco
San Francisco, California, 94115
United States
Anne Arundel Health System
Annapolis, Maryland, 21401
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21218
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
The Swedish Hospital
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Christos Patriotis, PhD, STUDY_DIRECTOR, National Cancer Institute (NCI)

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 Date2020-04-13
Study Completion Date2025-03

Study Record Updates

Study Start Date2020-04-13
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Uterine Lavage
  • Tumor DNA
  • Serum proteins
  • Ovarian neoplasms
  • Ovarian epithelial carcinoma
  • Ovarian cancer
  • Ovarian epithelial cancer
  • Neoplasms
  • Ovarian diseases
  • Early detection

Additional Relevant MeSH Terms

  • Ovarian Neoplasms
  • Ovarian Epithelial Carcinoma
  • Fallopian Tube Neoplasms
  • High Grade Ovarian Serous Adenocarcinoma
  • Stage I Ovarian Cancer
  • Stage II Ovarian Cancer
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8