Clinical trial NCT02296307: DOvEE - Diagnosing Ovarian & Endometrial Cancer Early
Official title: Diagnosing Ovarian & Endometrial Cancer Early (DOvEE) by Targeting Symptomatic Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
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
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 13600
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are 45+ years of age, living in greater Montreal. Women may self-identify and contact the DOvEE Study directly, or be referred from primary care or physicians or specialists.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of diagnoses in early, curable stage.
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of participants with physical morbidity related to the program as a measure of safety and tolerability
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Kirkland
country: Canada
facility: West Island Cancer Wellness Centre
state: Quebec
city: Laval
country: Canada
facility: Axion 50 plus
state: Quebec
city: Montreal
country: Canada
facility: Clinique Familiale Pas-A-Pas
state: Quebec
city: Montreal
country: Canada
facility: Clinique Médicale du Haut-Anjou
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre, Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Queen Elizabeth Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Lachine Hospital
state: Quebec
city: St Lambert
country: Canada
facility: Clinique du Dr. L. Quintal
state: Quebec
Study officials:
affiliation: McGill University
name: Lucy Gilbert, MD,MSc,FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gilbert L, Basso O, Sampalis J, Karp I, Martins C, Feng J, Piedimonte S, Quintal L, Ramanakumar AV, Takefman J, Grigorie MS, Artho G, Krishnamurthy S; DOvE Study Group. Assessment of symptomatic women for early diagnosis of ovarian cancer: results from the prospective DOvE pilot project. Lancet Oncol. 2012 Mar;13(3):285-91. doi: 10.1016/S1470-2045(11)70333-3. Epub 2012 Jan 17.