← Landscape

Trial NCT04794322

Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer

Phase
Not given
Sponsor
Massachusetts General Hospital
Conditions
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
Ages
30+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy) * Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer * Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy Exclusion Criteria: * Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer * Inability to provide informed consent * Age less than 30 yearsAge * Inability to obtain the minimum amount of blood * Inability to obtain the minimum amount of uterine lavage sample * At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL) * Prior history of known ovarian or endometrial cancerPrior malignancy * Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin * History of untreated high-grade cervical dysplasia (CIN3) * 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. * Currently pregnantPregnancy * Known Lynch syndrome

Restrictions found (3)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County