RecruitingNCT02296307

DOvEE - Diagnosing Ovarian & Endometrial Cancer Early

Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women


Sponsor

McGill University

Enrollment

13,600 participants

Start Date

Jan 1, 2012

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 Years

Inclusion Criteria12

  • Sign an approved informed consent form (ICF).
  • Be ≥ 45 years of age.
  • 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
  • Subjects must be willing to comply with study protocol

Exclusion Criteria5

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

Interventions

OTHERBlood test: CA-125 biomarker

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

OTHERSecond Test: Transvaginal Ultrasound

-Transvaginal Ultrasound at visit 1, day 1.

OTHERFollow-up phone call

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


Locations(8)

West Island Cancer Wellness Centre

Kirkland, Quebec, Canada

Axion 50 plus

Laval, Quebec, Canada

Clinique Familiale Pas-A-Pas

Montreal, Quebec, Canada

Clinique Médicale du Haut-Anjou

Montreal, Quebec, Canada

McGill University Health Centre, Royal Victoria Hospital

Montreal, Quebec, Canada

Queen Elizabeth Health Centre

Montreal, Quebec, Canada

Lachine Hospital

Montreal, Quebec, Canada

Clinique du Dr. L. Quintal

Saint-Lambert, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT02296307


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