Recruiting

Ovarian & Endometrial Cancer

Sponsor:

McGill University

Code:

NCT02296307

Conditions

Ovarian Neoplasms

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Blood test: CA-125 biomarker

Second Test: Transvaginal Ultrasound

Follow-up phone call

Study Details

Brief summary:

This study hopes to improve early detection of ovarian and endometrial cancers. It will determine if women with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency and/or early satiety, benefit from earlier surgery after screening by CA-125 ovarian cancer biomarker and transvaginal ultrasound.

Conditions

Ovarian Neoplasms

Study ID

NCT02296307

Start date

Jan, 2012

Status verified date

May, 2024

Completion date

Jan, 2026

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Sign an approved informed consent form (ICF).
2. Be ≥ 45 years of age.
3. Have at least one symptom outlined in below for a period of ≥2 weeks but ≤ 1 year:

  • Feeling full after eating only a few bites, loss of appetite
  • Diarrhea, constipation, bowel or rectum feels full, change in bowel habits, constant urge to have a bowel movement, painful or burning bowel movements, rectal pain, painful defecation
  • Bloating, distension of abdomen, clothes around the waist feel too tight, feel an abdominal mass
  • Weight loss not because of dieting
  • Nausea, vomiting, heartburn, gas, burping, indigestion
  • Increased urinary frequency, need to urinate urgently, pressure on the bladder, leaking urine, burning sensation when urinating, need to urinate but unable to do so, unable to empty bladder completely, feeling full after urinating
  • Vaginal discharge, bleeding, spotting, deep pain on intercourse
  • Discomfort or pain in abdomen, or pelvic region, or lower back
4. Subjects must be willing to comply with study protocol

Exclusion Criteria:

1. Previous bilateral salpingo-oophorectomy (BSO)
2. Previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum
3. Current bleeding per rectum, not due to haemorrhoids
4. Current frank haematuria
5. Symptoms that suggest the need for urgent clinical evaluation outside of a research protocol

Study Design

Enrollment

13600 participants

Anticipated

Interventions and Outcome Measures

Arms

DOvEE Participants

All symptomatic women who are eligible for participation in the DOvEE trial receive the same interventions:

Blood test: CA-125 biomarker at day 1 and week 6-8. Second Test: Transvaginal Ultrasound at day 1. Follow-up Phone Call: Confirms continuing health 6 months after last visit.

Interventions

Blood test: CA-125 biomarker

  • CA-125 biomarker blood test at visit 1, day 1.
  • CA-125 biomarker blood test at visit 2, week 6.

Second Test: Transvaginal Ultrasound

-Transvaginal Ultrasound at visit 1, day 1.

Follow-up phone call

Phone call 6 months after last visit to verify continued health.

Primary outcome measure

  • Proportion of diagnoses in early, curable stage. [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre, Royal Victoria Hospital

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Lucy Gilbert, MD,MSc,FRCOG

514-934-1934lucy.gilbert@mcgill.ca

Principal Investigator:

Lucy Gilbert, MD,MSc,FRCOG

Queen Elizabeth Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3L6

Principal Investigator:

Lucy Gilbert, MD,MSc,FRCOG

More Information

Sponsor

McGill University

Last update posted

May 2, 2024

Last verified

May, 2024

Keywords

  • Aged
  • Algorithms
  • CA-125 Antigen/blood*
  • Chi-Square Distribution
  • Early Detection of Cancer*
  • Feasibility Studies
  • Female
  • Humans
  • Logistic Models
  • Mass Screening/methods*
  • Middle Aged
  • Neoplasm Grading
  • Neoplasm Invasiveness
  • Neoplasm Staging
  • Ovarian Neoplasms/diagnosis*
  • Ovarian Neoplasms/epidemiology
  • Ovarian Neoplasms/immunology
  • Ovarian Neoplasms/ultrasonography
  • Pilot Projects
  • Predictive Value of Tests
  • Prevalence
  • Prognosis
  • Prospective Studies
  • Quebec/epidemiology
  • Tumor Burden

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2024-05-02.